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Controversies and Challenges in Sunscreen DISCLOSURE OF RELATIONSHIPS WITH INDUSTRY Photoprotection Darrell S. Rigel, MD MS Controversies and Challenges in Sunscreen Photoprotection

Darrell S. Rigel, MD MS DISCLOSURES Clinical Professor Neutrogena – C, A, H, I New York University Medical Center P&G – C New York, NY LaRoche Posay - H Beiersdorf – A, H, I

Duplicate

Melanoma – USA 2019

1/451/45 or 1/55 Lifetime Risk Invasive MM Why is this issue important? 1/74 1/100

1/150

1/250 1/600 1/1500

1930 1950 1980 1985 1993 2000 2010 2018

Rigel et al, NYU Melanoma Cooperative Group, 2019

Distribute Melanoma – USA 2019

1/35 1/451/45 Melanoma – US 1/55 Lifetime Risk 2019 Invasive MM 1/74 Not1/100 • Invasive = 96,480 1/150 ProjectedProjected 1/250 1/600 1/1500 •In-situ = 95,830

1930 1950 1980 1985 1993 2000 2010 2019 2025 Do Rigel et al, NYU Melanoma Cooperative Group, 2019

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Melanoma – USA 2019 US Annual Change in Melanoma Incidence Rate

6% 5.4% 5.5%

Lifetime Risk 1/231/23 5% Invasive and Insitu Males Females 192,310 total cases MM 4%

3.1% 3% 2.4%

2% 1.8%

1%

0.1% 0% 1930 1950 1980 1985 1993 2000 2019 1975-86 1987-2005 2006-10

Rigel et al, NYU Melanoma Cooperative Group, 2019 Siegel et al, Ca J Clinicians, 2019 Duplicate

US Annual Change in Melanoma Incidence Rate US Annual Deaths2 from Melanoma

6% 5.4% 5.5% 10000 9000 or 5% 7910 Males Females 8000

4% 3.7% 7000

3.1% 6000 3% 5000 2.4% 4000 2% 1.8% 1.8% 3000

1% 2000

0.1% 1000 0% 0 1975-86 1987-2005 2006-10 2011-15

Siegel et al, Ca J Clinicians, 2019 ACS

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US Annual Deaths2 from Melanoma US Annual Deaths2 from Melanoma

10000 10000

8450 9000 8110 9000 8110 7910 7910 8000 8000 7000 7000 6000 6000 5000 Not 5000 4000 4000 3000 3000 2000 2000 1000 1000 0 0

Do ACS ACS

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US Annual Deaths2 from Melanoma US Annual Deaths2 from Melanoma

10000 10000 8650 8650 8700 8450 8450 9000 8110 9000 8110 7910 7910 8000 8000 7000 7000 6000 6000 5000 5000 4000 4000 3000 3000 2000 2000 1000 1000 0 0

ACS ACS Duplicate

US Annual Deaths2 from Melanoma US Annual Deaths from Melanoma

10000 10000 9180 8790 8790 8650 8700 8650 8700 8450 8450 9000 8110 9000 or8110 7910 7910 8000 8000 7000 7000 6000 6000 5000 5000 4000 4000 3000 3000 2000 2000 1000 1000 0 0

ACS ACS

Distribute US Annual Deaths from Melanoma US Annual Deaths from Melanoma

9710 9480 9480 10000 9180 10000 9180 8790 8790 8650 8700 8650 8700 8450 8450 9000 8110 9000 8110 7910 7910 8000 8000 7000 7000 6000 6000 5000 Not 5000 4000 4000 3000 3000 2000 2000 1000 1000 0 0

Do ACS ACS

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US Annual Deaths from Melanoma US Annual Deaths from Melanoma

9940 9940 10130 9710 9710 9480 9480 10000 9180 10000 9180 8790 8790 8650 8700 8650 8700 8450 8450 9000 8110 9000 8110 7910 7910 8000 8000 7000 7000 6000 6000 5000 5000 4000 4000 3000 3000 2000 2000 1000 1000 0 0

ACS ACS Duplicate

US Annual Deaths from Melanoma US Annual Deaths from Melanoma

9940 10130 9940 10130 9710 9730 9710 9730 9480 9480 9320 10000 9180 10000 9180 8790 8790 8650 8700 8650 8700 8450 8450 9000 8110 9000 or8110 7910 7910 8000 8000 7000 7000 6000 6000 5000 5000 4000 4000 3000 3000 2000 2000 1000 1000 0 0

ACS ACS

Distribute US Annual Change in Melanoma Death Rate US Annual Deaths from Melanoma

9940 10130 9710 9730 3% 9480 9320 10000 9180 2.3% 8790 8650 8700 8450 2% 9000 8110 7910 1.1% 0.8% 8000 7230 1% 0.5% 0.4% 2012-16 7000 0% -0.2% 6000 -1% 1975-88 1989-2005 2006-11 5000 Not -2% 4000 -3% 3000 -4% 2000 Males Females 1000 -5% -5.2%-5.0% 0 -6%

Do ACS Siegel et al, Ca J Clinicians, 2019

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US Lifetime Risk for Invasive Melanoma - 2019 Primary vs Secondary Prevention Non-Hispanic Whites 4% 3.7% Primary = Protection Secondary = Early Detection

3% 2.7%

2% 1 in 27

1% 1 in 40

0% Male Female Siegel et al, Ca J Clinicians, 2019 Impact  Incidence Impact  Mortality Duplicate

What can we conclude from this data?

 Secondary prevention efforts appear to or be making an impact  Primary prevention not as impactful What Causes Melanoma? The overwhelming majority  Focus of our efforts on primary caused by UV exposure prevention – behavioral change (Sunscreen usage a component)

Distribute Melanoma vs. Latitude USA UV and Melanoma Risk • Sunlight is the major environmental risk factor for

100 melanoma • Examine if S-shaped curves describe the relationship Hawaii between solar UV doses and MM incidence and the % of MM that can be directly related to UV exposure Atlanta

Seattle Connecticut • Analysis indicates that S-shaped associations describe NotDetroit Utah Los Angeles MM incidence/100K San Jose NM the data well (P < 0.0001). San Francisco Iowa 10 • Conclusion: 50 45 40 3035 25 20 15 Latitude (deg N) ─ Between 89 and 95% of the annual CM cases are caused by solar UV exposure. ─ Avoidance of UV radiation will reduce the incidence of MM. Do SEER 2015 Juzeniene et al. Int J Hyg Environ Health. 2014

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Sunburn, Skin Aging and Skin Cancer are Caused by Same Are ALL melanomas Wavelengths of Sunlight caused by UV exposure? Sensitivity

No, but the vast UVB UVA

majority are! Wavelength (nm)

1. ISO 17166/CIE S007/E. 2. de Gruijl FR, Van der Leun JC. Health Phys. 1994;67(4):319-325. 3. Kligman LH, Sayre RM. Photochem Photobiol. 1991;53(2):237-242. Duplicate or Does Sunscreen Usage Lower Skin Cancer Risk?

34

Distribute Reduced melanoma risk after regular Sunscreen Use Clinically Shown to Prevent Squamous- sunscreen use Cell Carcinomas • 1,621 randomly selected residents of Nambour Daily sunscreen application and betacarotene supplementation in prevention of basal- cell and squamous-cell carcinomas of the skin: a randomised controlled trial (Queensland) Australia, age 25 to 75 years, were Adèle Green, Gail Williams, Rachel Neale, Veronica Hart, David Leslie, Peter Parsons, Geoffrey C Marks, Philip Gaffney, Diana Battistutta, Christine Frost, Carolyn Lang, Anne Russell randomly assigned to daily or discretionary sunscreen application to head and arms • Sunscreen used daily vs discretionaryNot use over 4 year RESULTS: • Treated for 5 years then followed for 10 years time period 40% fewer SCC lesions in • Use of an SPF 16 product, subjects using daily SPF 16 weight of product brought in sunscreen (p<0.05) every 3 months measured

Green et al, J Clin Oncol, 2011 Do Lancet. 1999;354(9180):723-9.

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Reduced melanoma risk after regular Sunscreen Usage and Melanoma Risk sunscreen use All Melanomas

1 1

0.75

0.5 Relative Relative Risk 0.25

0

J Clin Oncol. 2011 Jan 20;29(3):257-63. doi: 10.1200/JCO.2010.28.7078. Epub 2010 Dec 6 Discretionary 2 Duplicate

Sunscreen Usage and Melanoma Risk Sunscreen Usage and Melanoma Risk All Melanomas or Invasive MMs 1 1 1 1

0.75 0.75

0.5 0.5 0.5 Relative Risk Relative Risk Relative 0.25 0.25

0 0 Discretionary Daily Discretionary 2

Distribute Sunscreen Usage and Melanoma Risk Reduced melanoma risk after regular Invasive MMs sunscreen use • 1,621 randomly selected residents of Nambour (Queensland) Australia, age 25 to 75 years, were randomly assigned to daily or discretionary sunscreen 1 1 application to head and arms

0.75 • Treated for 5 years then followed for 10 years Not • Only 11 new MMs in daily group vs. 22 (p=0.051) 0.5 • 2 Invasive MMs in daily group vs.11

Relative Risk Relative • Conclusions: 0.25 0.27 – Melanoma risk significantly lowered by regular sunscreen use in adults 0 Green et al, J Clin Oncol, 2011 Do Discretionary Daily

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Sunscreen Use and Melanoma Risk Among Young Australian Adults Skin cancers in Australia prevented by regular sunscreen use • Assessed early-life sunscreen use and risk of cutaneous MM before age 40 • Estimated the proportion of skin cancers that would have • 629 cases and 240 controls occurred but were likely prevented by regular sunscreen use • Risk of MM was less with higher use of sunscreen in childhood (OR=0.60) and lifetime (OR=0.65) • Regular sunscreen use prevented around 14,190 persons from developing SCCs (PF 9.3%) and 1,730 from Melanoma • Protective association was stronger for people reporting blistering sunburn, receiving a diagnosis of melanoma at a younger age, or having many nevi. (PF 14%) • Total sun exposure inversely weighted by sunscreen use (as a measure of sun • Conclusions: exposure unprotected by sunscreen) was significantly associated with – Prevailing levels of sunscreen use probably reduced skin cancer melanoma risk (OR=1.80) incidence by 10-15% • Conclusion: – Sunscreen should be a component of a comprehensive sun protection strategy ⁻ Regular sunscreen use is significantly associated with reduced risk of cutaneous MM among young adults. Watts et al, JAMA Dermatol, 2018 Olsen et al, Aust N Z J Public Health. 2015 Duplicate

How many melanomas might be prevented if more people How many melanomas might be prevented if more people applied sunscreen regularly? applied sunscreen regularly? Calculated the PF, the proportional difference between the observed number of melanomas arising under prevailing levels of 5% annual or increase in sunscreen use for 10 years (50% increase)

British Journal of Dermatology Olsen et al, Br J Dermatol, 2017 14 DEC 2017 DOI: 10.1111/bjd.16079

Distribute How many melanomas might be prevented if more people How many melanomas might be prevented if more people applied sunscreen regularly? applied sunscreen regularly? Calculated the PF, the proportional difference between the observed number of melanomas arising under prevailing levels of 5% annual increase in sunscreen use for 10 years (50% increase) Estimated that cumulatively to 2031, 231,053 fewer melanomas would arise inNot the U.S. white population (PF 11%)

British Journal of Dermatology Do Olsen et al, Br J Dermatol, 2017 14 DEC 2017 DOI: 10.1111/bjd.16079

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How many melanomas might be prevented if more people MM risk using SPF<15 vs SPF >15 applied sunscreen regularly? Percentage improvement with regular use of SPF>15 Calculated the PF, the proportional difference between the observed 50% number of melanomas arising under prevailing levels of 5% annual increase in sunscreen use for 10 years (50% increase) 40% Estimated that cumulatively to 2031, 231,053 fewer melanomas 30% 33% would arise in the U.S. white population (PF 11%) Lowered risk of melanoma Conclusions: 20% 21% 20% • Interventions to increase use of sunscreen would result in reductions in melanoma incidence 10% • Countries with a high incidence of melanoma should monitor levels of 0% sunscreen use Blond/Red Hair Freckling in Sun Using SPF > 15

Norwegian Women Study N = 143,844 Olsen et al, Br J Dermatol, 2017 Ghiasvand et al, J Clin Oncol, 2016 Duplicate or

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Development of SPF HighestHighest SPFSPF AvailableAvailable

SPF 15+ Available • Correlation of indoor solar simulator with natural 60 Osterlind Berwick 30 - 50 82-85 sunlight 50 87-89 Westerdahl Beitner Rodenas 95-97 78-83 40 88-93 Graham Holly • Natural sunlight effects could be duplicated with 74-80 30 Klepp 81-86 Naldi 74-75 Green 8-15 Autier 94-97 solar simulator 20 79-80 91-92 Espinosa Holman 2 - 4 Arranz 10 80-82 Westerdahl 94-97 88-90 0 1960-70's Mid 1980's 1990's Sayre et al, Arch Dermatol, 1978

Duplicate or

How high is high enough? How high is high enough?

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Broad spectrum high-SPF photostable sunscreen with high UVA-PF can protect against cellular damage at high UV levels • To evaluate if high-SPF sunscreen can protect skin at the cellular level under UV exposure doses [>50 MEDs] similarly to the SPF value • Sunburn cells, Langerhans cells, thymine dimers, protein 53 (p53), and matrix metalloproteinase (MMP)-1 and MMP-9 No topical No topical No topical SPF 55 endpoints were evaluated in biopsies from 12 subjects: Delivered 0 1 MED 3 MED 55 MED – unprotected exposed to 0, 1 and 3 MED UVR MEDs – SPF 55 protected exposed to 55 MED of UV radiation Theoretical 0 1 MED 3 MED 1 MED Equivalent • After 55 MEDs, sunscreen-protected sites showed either significantly less damage or no difference than the 1 MED- • 12 Subjects, phototype 1-3 • Standard 2 mg/cm2 sunscreen application rate exposed unprotected sites • MED observations at 24 hours • 3mm punch biopsies taken at 24 hours • Conclusions: • SPF 55 sunscreen contained: – High-SPF sunscreen with high UVA-PF can provide 5% octyl salicylate, 10% homosalate, 6% oxybenzone, 3% avobenzone, and 2.8 % octocrylene proportionately high protection against multiple cellular Photodermatol Photoimmunol Photomed. 2014 Aug;30(4):212-9. doi: 10.1111/phpp.12124. Epub 2014 May 27 damage markers Cole et al, Photodermatol Photoimmunol Photomed. 2014 Duplicate

Sunscreen Use Not Only Protects, But Promotes Reversal of Photodamage Daily use of a facial photostable broad spectrum sunscreen (SPF 30) over one year or significantly improves clinical evaluation of photoaging Manpreet Randhawa, PhD,* Steven Wang, MD,† James J. Leyden, MD,‡ Gabriela O. Cula, PhD,* Alessandra Pagnoni, MD,x and Michael D. Southall, PhD*

• Clinical evaluations showed all photoaging parameters improved significantly from baseline as early as week 1- 2, and continued until week 52 – Skin texture, clarity, and mottled/discrete pigmentation were most improved parameters – Self-assessment showed significant improvement in skin clarity and texture

100% of subjects showed improvement in skin clarity and texture

Distribute SPF levels vs. UVB absorption It’s Not About How Much Is Blocked

100 It’s what gets through that counts against a lifetime of damage vs. 50 • Moving from SPF 15 to 30 is only incremental 3.3% added “protection” • Moving from SPF 30 to 50 is only 1.7% added “protection”

100 Marginal increase in UVB protection from SPF 90 % Blocked 80 Not50 to SPF 100 is only 1% 70 60 50 40 30 20 % Blocked SunburningUVRBlocked % 10 0 Do 0 102030405060708090100

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SPF 100 = Greater Sun Protection It’s Not About How Much Is Blocked Over Lifetime: The Bucket Theory

It’s what gets through that counts against a lifetime of damage

• More relevant factor in assessing sunscreen effectiveness is amount of damaging rays transmitted through sunscreen vs. amount of damaging rays blocked • Percentage transmitted over time is inversely proportional to the SPF • SPF 100 transmits half the damaging rays compared with SPF 50

67 Duplicate

Shift Conversation to Cumulative Damage Patients Often Don’t Apply Recommendedor Amounts of Sunscreen Although daily benefits of HIGH SPF are important, cumulative benefits over a lifetime can be life-saving •Protection for a day at the beach against sunburn is one thing •Protection over a lifetime against skin cancer and photoaging is a another critical consideration in sun safe

behavior Average Size 4- 6 Oz

Distribute SPF levels vs. UVB absorption with real world application 100 Underusage of Sunscreen vs. Large variation in sunscreen application (many 50 use less than recommended 2mg/cm2) Users received a mean SPF of 20-50% of But this assumes sunscreen applied at tested expected due to inadequate application Notconcentration (2mg/cm 2) Underprotection due to inadequate application Typically, 25-50% of rated amount applied might explain why sunscreen use has been reported in some studies as a risk factor for melanoma Do Stokes et al , Photodermatol Photoimmuno Photomed, 1997

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Impact of under application of sunscreen Patients Under Apply Sunscreen • SPF of sunscreens are tested using a thickness of 2 2 mg/cm •Numerous studies have shown that • Investigations show that sunscreen under natural consumers typically under apply conditions is applied insufficiently with amounts product by 1/4 to 1/2 of what should be applied about 0.39 to 1.0 mg/cm2 • Missing areas and UV radiation exposure before •Data shows that consumers seldom re-apply after the initial application sunscreen application are other pitfalls that reduce the protective effect of sunscreens considerably •Not all body areas get comprehensive application and coverage

Petersen et al, Photodermatol Photoimmunol Photomed. 2014 74 Duplicate

High-SPF Compensates for Under-Application of Sunscreen Methods • 4 lotionor and 2 spray sunscreens, selected based on formulation similarities • OBJECTIVE: To measure the actual SPF values – (A) - SPF 30 lotion sunscreen (Coppertone Sport 30) of various sunscreens (SPF 30 to 100) applied – (B) - SPF 100 lotion sunscreen (Neutrogena Ultra Sheer Lotion in the reduced amounts typically used by SPF 100) – consumers – (C) - SPF 100 spray sunscreen (Neutrogena Ultimate Sport Spray SPF 100) – – (D) - SPF 50 lotion sunscreen (Coppertone Sport 50+) – – (E) - SPF 50 spray sunscreen (Coppertone Sport 50 Continuous Spray) – (F) - SPF 70 lotion sunscreen (Coppertone Sport 70+) Ouyang et al, J Am Acad Dermatol, 2012 Ouyang et al, J Am Acad Dermatol, 2012

Distribute High SPF Offers Meaningful Margin of Safety Methods • 4 lotion and 2 spray sunscreens, selected based on formulation similarities – (A) - SPF 30 lotion sunscreen – (B) - SPF 100 lotion sunscreen Journal of the American Academy of Dermatology. 2012;67(6):1220–1227. –

• SPF protectionNot is – (C) - SPF 100 spray sunscreen directly and linearly – proportional to the application quantity – (D) - SPF 50 lotion sunscreen • Use of high-SPF – products can provide meaningful – (E) - SPF 50 spray sunscreen protection that low- SPF products may not when – (F) - SPF 70 lotion sunscreen underapplied Ouyang et al, J Am Acad Dermatol, 2012 Do Ouyang et al, J Am Acad Dermatol, 2012

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Methods Actual SPF at different application doses

A-Label SPF: D-Label SPF: F-Label SPF: B- Label SPF: E- Label SPF: C-Label SPF: 30 50+ 70+ 100 50 100 spray spray

• Application densities: Mean SPF at 31.0 52.8 70.6 104.6 50.7 105.3 –0.5, 1.0, 1.5 and 2.0 mg/cm2 2 mg/cm2 Mean SPF at 21.8 41.3 54.4 79.3 38.6 75.0 • Products applied according to the standard protocol for SPF 1.5 mg/cm2 Mean SPF at Testing, on the back of human volunteers 16.0 26.0 37.1 55.9 25.7 50.1 1 mg/cm2

Mean SPF at 8.8 13.9 19.3 27.1 12.6 22.4 0.5 mg/cm2

Ouyang et al, J Am Acad Dermatol, 2012 Ouyang et al, J Am Acad Dermatol, 2012

Duplicate

SPF 50+ Status Results • Sunscreensor with SPF of 50 or more are • There was a linear relationship between application density and the actual SPF available in some other developed countries, including New Zealand, the US and many • Sunscreens labeled SPF > 50 provided significant protection European countries even when applied at “real world” typical application densities • Australia and other countries have an SPF 50+ cap

Ouyang et al, J Am Acad Dermatol, 2012

Distribute SPF Cap 50+? SPF Cap 50+?

• Higher SPFs have better protection at “real • Higher SPFs have better protection at “real world” application concentrations world” application concentrations Not• 50+… Is it 51 or 100? • 50+… Is it 51 or 100? • What will be the incentive to develop a better sunscreen if there is no way to reflect Do that on the label?

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High SPF is Durable in Real World Use

Realistic sunscreen durability—A randomized, double-blinded, controlled clinical study H. Ouyang; K. Meyer; P. Maitra; S. Daly; A. Farberg; D. Rigel, MD Which is better? • Evaluation of SPF 70 sunscreen over 8 hours with exercise and 80 minutes of water exposure Shade? • Reapplication of SPF products is critical to compensate for missed spots, under-application or rub-off; however, many people do not follow recommendations to reapply every 2 hours High SPF Sunscreen?

Higher SPF sunscreens may provide an additional margin of safety for people who do not reapply as recommended • After 8 hours + 80 min water exposure, SPF at 64.3

Journal of the American Academy of Dermatology , Volume 74 , Issue 5 , AB228 85 86 Duplicate

Objective: Methods • Randomized,or Evaluator-blinded, Controlled Study • To directly measure sunburn protection • Lakeside Beach near Dallas Texas, August 12 offered by shade from a beach umbrella in – 75-90 degrees F comparison to a high SPF sunscreen – Horizontal UV Intensity 3-5 MEDs/hour

• 81 Participants – Sunscreen ONLY Group (SPF 100) – Shade ONLY Group (beach umbrella)

Ou-Yang et al, JAMA Dermatol, 2017

Distribute Methods Methods SUNSCREEN Group SHADE Group

• Neutrogena Ultra Sheer SPF 100 • Standard beach umbrella • Instructed to apply following label directions • Round, 80” diameter, 75” height • Sit atNot beach (no water activity) for 3.5 hours • UPF rating 1000+ • Reminded to reapply after 2 hours • Sit under umbrella shade at beach for 3.5 hours – Not allowed to use sunscreen • Reminded to reposition as solar angle changed Do Ou-Yang et al, JAMA Dermatol, 2017 Ou-Yang et al, JAMA Dermatol, 2017

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Methods Evaluation • 24 hours after beach sun exposure • 7 body sites evaluated (evaluator blinded to group) – face, upper chest, back of neck, left/right arm, left/right leg • Clinical Evaluation • 0 = no sunburn • 1 = possible sunburn, not clearly defined • 2 = defined redness • 3 = severe sunburn, pronounced redness • 4 = edema, blisters • Compared scores to baseline (baseline = 0 = NO evidence of sunburn at start study) Ou-Yang et al, JAMA Dermatol, 2017 Ou-Yang et al, JAMA Dermatol, 2017

Duplicate

Results Results

SUNSCREEN ONLY - Average Sunburn Score SHADE ONLY - Average Sunburn Score 0.3 or1

0.75 0.2

0.5

0.1 0.25

0 0 Face Upper Back of Right Arm Left Arm Right Leg Left Leg Face Upper Back of Right Arm Left Arm Right Leg Left Leg Chest Neck Chest Neck

Sunscreen group had significant increase (p<0.05) in sunburn for face only Shade group had significant increase (p<0.001) in sunburn for all body sites Ou-Yang et al, JAMA Dermatol, 2017 Ou-Yang et al, JAMA Dermatol, 2017

Distribute Results Results

Averaged Global Score Percent of Subjects with Sunburn 0.8 100%

Shade 75% 0.6 ONLY

50% 0.4

25% Not P<0.001 0.2 Sunscreen ONLY 0% Shade ONLY Sunscreen ONLY 0 Baseline Post Exposure Global Sunburn Scores: Shade Group ONLY: 78% subjects had increased sunburn score Both groups revealed significant (p<0.001) increase in global sunburn scores Sunscreen Group ONLY: 25% subjects had increased sunburn score Do Ou-Yang et al, JAMA Dermatol, 2017 Ou-Yang et al, JAMA Dermatol, 2017

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Results Conclusions Sunburn Scores Compared • Seeking shade alone may not provide sufficient SHADE ONLY SUNSCREEN ONLY protection for extended sun UV exposure 1

0.75 • Shade Protection Factor: challenging to quantify 0.5 given multiple factors 0.25

0 Face Upper Back of Right Arm Left Arm Right Leg Left Leg Chest Neck

Sunscreen only group vs. Shade only group: • Shade only had significantly increased (p<0.001) sunburn scores

Sunburn Score ≥ 2 • Shade only Group: 16 participants Ou-Yang et al, JAMA Dermatol, 2017 Ou-Yang et al, JAMA Dermatol, 2017 • Sunscreen only Group: 2 participants Duplicate

All shade may not be created equally! Conclusions

Reflected/ scattered by • Seeking shade alone may not provide sufficient clouds or protection for extended sun UV exposure • Shade Protection Factor: challenging to quantify given multiple factors Reflected/ scattered by atmosphere • Neither shade nor high SPF sunscreen alone Direct from sun prevented sunburn completely – National Societies/Groups should consider changing

Reflected/ messaging to combining multiple sun protective scattered by ground measures, rather than rely on a single approach

Ou-Yang et al, JAMA Dermatol, 2017 Ou-Yang et al, JAMA Dermatol, 2017

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Impact of sunscreen agent • Sunscreens are regulated by OTC monographs because they are drugs that are Generally Recognized as Safe and Effective (GRASE) andNot high SPF formulation • Variety of proposals included: - Cap max SPF values at 60+ - Require SPF15+ sunscreens to also be broad spectrum and provide increasing UVA regulations protection as SPF increases - Active ingredients present on front of package - Revised SPF, broad spectrum, water resistance statements - Clarified FDA expectations for sunscreen testing 101 Do Food and Drug Administration. Sunscreen Drug Products for Over-the-Counter Human Use. Federal Register. 2019.

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GRASE Insufficient Data Not GRASE Zinc Oxide Avobenzone PABA Titanium Dioxide Cinoxate Trolamine Salicylate Dioxybenzone Ensulizole Homosalate Meradimate Octinoxate Octocrylene Does higher SPF protect Oxybenzone Padimate O Sulisobenzone significantly better in real • FDA calling on industry and interested parties to provide data for the 12 ingredients with insufficient data for GRASE determination world settings? • Seeking public comment until 90 days after 2/26/2019 • Final rule to be published by 11/26/2019

Food and Drug Administration. Sunscreen Drug Products for Over-the-Counter Human Use. Federal Register. 2019. 104 Duplicate

High SPF formulation more effective during intense UV exposures Sunscreen – Proposed Rule on SPFs • SPF 85 formulation tested vs. SPF 50 • orProposing to limit SPF to “50+” • 56 subjects applied sunscreen to face while skiing – Acknowledged that SPFs higher than 50 have been at Vail, Colorado 1/13/08 substantiated and results are validated and repeatable – Additional data demonstrating additional clinical benefit • 1 application only at start of day above SPF 50 are being collected by the FDA • Average hours exposed 5.0 hours • Sunscreens labeled with SPFs above 50 may • Noon Sun 22 minutes = 1 MED remain on the market until this proposed rule • 7/28 sunburned SPF 50 vs. 1/28 SPF 85 (p=0.02) becomes final, provided they follow the appropriate SPF test. • Conclusion: • Depending on how this proposed rule is – SPF 85 formulation more effective than SPF 50 in protecting from sunburn with a single application in a finalized, these products may/may not be able high UV test environment to continue on the market. Russak et al, JAAD 2010

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• For each subject: 1. How much sunscreen was used?

2. How much time did each Not individual subject spend in the sun?

3. Were there reapplications Do (not allowed in study)?

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In-vivo comparison of SPF 100 vs 50 in Actual Use Conditions

110 Duplicate

BACKGROUND • In the 2011 proposed monograph, the US Food and Drug Administration requested additionalor data stating “there is currently insufficient evidence that there is clinical benefit to the consumer at SPF above 50.” • In real-world settings, consumers apply sunscreens at densities lower than are used to clinically determine SPF and the linear dependence of SPF to application density is well established.

Williams et al, JAAD, 2018

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BACKGROUND • In the 2011 proposed monograph, the US Food and Drug Administration requested additional data stating “there is currently insufficient evidence that there is clinical benefit to the consumer at SPF above 50.” • In real-world settings, consumers apply sunscreens at densities lower than are used to clinically determine SPF and the linear dependence of SPF to application density is well established. • It is hypothesized that a sunscreen with a higher SPF would provide greater in-use efficacy compared with one currently labeled at the proposed maximum of SPF 50+. • Objective of this study was to evaluate the difference in sunburn protection provided by different SPF sunscreens during a day of downhill snow skiing. Williams et al, JAAD, 2018 Duplicate

METHODS STUDY DESIGN • 199 healthy men and women ≥18 years of age participated in a one day split face, randomized, double blind study in Vail, Colorado. • Participants andor evaluator were blinded to test product identity. Participants (Fitzpatrick skin type I to III, Erythema Score of 0.5 or less) were randomized • The difference in sunburn protection provided by two currently available to one of two treatment regimens for the face and neck: sunscreens (SPF 50+ and SPF 100+) was evaluated. (SPF 50+ on left & SPF 100+ on right) or (SPF 100+ on left & SPF 50+ on right) • Products were supplied in a kit containing two overwrapped tubes of sunscreen marked “right” and “left.” Each subject wore both sunscreens simultaneously, with product application randomized to either the right or • Products Evaluated left side of the face. • Neutrogena® Ultra Sheer® Dry-Touch Sunscreen Lotion Broad Spectrum • Subjects utilized the sunscreens as they would normally during ski activities. SPF 100+ (UPC 086800873105) Diaries were used to record sun exposure time and the frequency and timing • Banana Boat ® Sport Performance® with Powerstay Technology Sunscreen of sunscreen re-applications. Lotion Broad Spectrum SPF 50+ (UPC 079656045130) • Subjects reported the next morning for clinical evaluation. Williams et al, JAAD, 2018 Williams et al, JAAD, 2018

Distribute STUDY DESIGN STUDY DESIGN • Participants self-applied the pre-weighed study products upon receipt, prior to outdoor sun exposure as they normally would. To address any questions by subjects about product application or usage, subjects were referred to the product study labels which contained the complete sunscreen Drug Facts information without ingredients list.

• Time spent outdoors was captured by the subjects in the provided exposure Not diary and solar conditions were tracked utilizing a stationary radiometer. An application diary was used to record the frequency and time of any product reapplications.

• Primary and Secondary efficacy endpoints were evaluated by clinical grading the morning after the recreational sun exposure period. At which time study products were also collected and weighed to determine usage. Do Williams et al, JAAD, 2018 Williams et al, JAAD, 2018

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STUDY PARTICIPATION AND CONDITIONS STUDY PARTICIPATION AND CONDITIONS • Daily solar conditions tracked: • Conducted on a sunny day (March 21st, 2016) during normal Direct UVA and UVB metered 10:00 am to 4:30 pm local time recreational skiing/snowboarding in Vail, Colorado, USA (base • Average cumulative un-weighted subject UV exposure doses* elevation approx. 8,200’). 54.893 J/cm2 UVA 1.009 J/cm2 UVB 25+ MEDs for • 199 participants (42% women, 37±16 years old); Fitzpatrick Type II Skin skin Type I (16%), Type II (73%), & Type III (11%)

•

• Participants averaged 6.05 ± 1.29 hours of sun exposure *UV exposure calculated from pairing of radiometry data averaged at half hourly intervals with diary reported subject exposure time and duration. Denotes diffuse cloud cover

10:00 am 12:00 pm 2:00 pm 4:00 pm

Williams et al, JAAD, 2018 Williams et al, JAAD, 2018 Duplicate

RESULTS RESULTS Primary Endpoint Primary Endpoint or P < .001 SPF 50 side of face 11x 55.3% more likely

39.7% to be (n = 199) (n = sunburned Percentage of of subjects Percentage than SPF 5.0% 100 side

More sunburned No difference More sunburned on SPF 50+ side on SPF 100+ side Williams et al, JAAD, 2018 Williams et al, JAAD, 2018

Distribute RESULTS RESULTS Secondary Endpoint Usage

Erythema was significantly lower on the SPF 100+ protected side of the No differences were observed in usage, application density, or reapplication frequency face, and erythema progression was observed to be more than twice as of the study products Notsevere on the SPF 50+ protected side

1.10 mg/cm2 1.04 mg/cm2 Average Product Application Density Do Williams et al, JAAD, 2018 Williams et al, JAAD, 2018

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RESULTS RESULTS Post Hoc Analysis Post Hoc Analysis The number of sunscreen reapplications was not observed to diminish SPF 100+ sunscreen was significantly more effective the enhanced protection benefit of the SPF 100+ product at protecting against sunburn in all examined skin types

Williams et al, JAAD, 2018 Williams et al, JAAD, 2018 Duplicate

CONCLUSIONS CONCLUSIONS • Product usage data confirms that consumers apply sunscreen at densities • The SPF 100+or sunscreen was significantly more effective in protecting far less than that utilized to determine the SPF value listed on the product against sunburn than the SPF 50+ sunscreen for all skin types evaluated label • These findings demonstrate that there is a need for sunscreens labelled • In this real-world, actual usage study, the SPF 100+ sunscreen was with SPFs greater than 50+ to provide consumers with better choices for significantly more effective in protecting against sunburn than the SPF sunburn protection 50+ sunscreen

• Reapplication data confirms that consumers typically reapply the product less frequently then recommended on product label and that reapplication is observed to preserve but not enhance sunscreen efficacy

Williams et al, JAAD, 2018 Williams et al, JAAD, 2018

Distribute Sub-optimal Application of a High SPF Sunscreen Prevents Epidermal DNA Sub-optimal Application of a High SPF Sunscreen Prevents Epidermal DNA Damage in Vivo Damage in Vivo • The cyclobutane pyrimidine dimer (CPD) is a potentially mutagenic DNA • The cyclobutane pyrimidine dimer (CPD) is a potentially mutagenic DNA photolesion that is the basis of most skin cancers photolesion that is the basis of most skin cancers • An 50+ SPF formulation was applied at 0.75, 1.3 and 2.0 mg/cm2. • An 50+ SPF formulation was applied at 0.75, 1.3 and 2.0 mg/cm2. • 30 SED UVR exposures • 30 SED UVR exposures • Holiday behaviorNot was also simulated by UVR exposure for 5 consecutive days • Holiday behavior was also simulated by UVR exposure for 5 consecutive days

CPD expression

Control 0.75mg/cm2 2mg/cm2 Do Young et al, Acta Derm Venerol, 2018 Sunscreen Concentration Young et al, Acta Derm Venerol, 2018

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Sub-optimal Application of a High SPF Sunscreen Prevents Epidermal DNA Damage in Vivo Time to Apply Sunscreen Affects Photoprotection • The cyclobutane pyrimidine dimer (CPD) is a potentially mutagenic DNA • photolesion that is the basis of most skin cancers N=31 volunteers wearing swimwear applied sunscreen twice • Time spent on application and amount of sunscreen applied were • An 50+ SPF formulation was applied at 0.75, 1.3 and 2.0 mg/cm2. measured • 30 SED UVR exposures • Average first application took 4:15, time decreased 15% during • Holiday behavior was also simulated by UVR exposure for 5 consecutive days second application • Sunscreen significantly reduced DNA damage at 1.3 and 2.0 mg/cm2 in all • Linear relationship between time applying and amount applied 2 cases and for the 5 day study for 0.75 mg/cm . • 2.21g of sunscreen / minute • Conclusion: • Conclusion: ⁻ Results support the role of very high SPF sunscreens, even if they are - Advising patients to apply sunscreen over a longer period of time may typically used at ~1/3 of the thickness required for SPF labelling. increase the amount applied and thus improve actual SPF provided.

Young et al, Acta Derm Venerol, 2018 Heerfordt, et al. Photodermatol Photoimmunol Photomed. 2018. Duplicate

GRASE Insufficient Data Not GRASE Zinc Oxide Avobenzone PABA Titanium Dioxide Cinoxate Trolamine Salicylate Dioxybenzone or Ensulizole Homosalate Meradimate Octinoxate • Sunscreens are regulated by OTC monographs because they are drugs that Octocrylene are Generally Recognized as Safe and Effective (GRASE) Oxybenzone Padimate O • Variety of proposals included: Sulisobenzone - Cap max SPF values at 60+ • FDA calling on industry and interested parties to provide data for the 12 - Require SPF15+ sunscreens to also be broad spectrum and provide increasing UVA ingredients with insufficient data for GRASE determination protection as SPF increases - Active ingredients present on front of package • Seeking public comment until 90 days after 2/26/2019 - Revised SPF, broad spectrum, water resistance statements • Final rule to be published by 11/26/2019 - Clarified FDA expectations for sunscreen testing Food and Drug Administration. Sunscreen Drug Products for Over-the-Counter Human Use. Federal Register. 2019. Food and Drug Administration. Sunscreen Drug Products for Over-the-Counter Human Use. Federal Register. 2019.

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New York Times

May 23, 2019

Duplicate

Oxybenzone Oxybenzone absorbs light in the UV-B (280–315 nm) and short-wavelength UV-A (315–355 nm) ranges. or

The compound was first synthesized in 1906 in Germany and was developed in the 1950s by the now-defunct General Aniline & Film (GAF) Corp.

The US Food and Drug Administration approved the use of oxybenzone in sunscreen products in the 1980s.

In 2013, a revised approval allowed concentrations of up to 6%.

Distribute Oxybenzone and Sunscreens: A Critical Review of the Evidence and Sunscreens and Oxybenzone a Plan for Discussion with Patients • Concerns have been raised regarding the environmental effects of commonly used organic ultraviolet (UV) filters, including oxybenzone (benzophenone-3) Given these controversies, it is critical that dermatologists have a • In laboratory settings, oxybenzone has been implicated as a possible clear understanding of the underlying issues related to oxybenzone contributor to coral reef bleaching. in order to effectively counsel their patients. • Has been identifiedNot in various species of fish worldwide • In July 2018, the Hawaii Governor signed a law prohibiting sale and The purpose of this paper was to provide dermatologists with a distribution of sunscreens containing oxybenzone (taking effect in 2021) framework for presenting this issue to patients. • Conclusion: - Concern about the environmental impact of organic UV filters should not detract from educating the public on the importance of photoprotection Do Schneider et al, JAAD, 2019 Mirsky et al, SKIN, 2018

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Oxybenzone and Sunscreens: A Critical Review of the Evidence and a Plan for Discussion with Patients WHY IS OXYBENZONE USED IN THE MAJORITY OF U.S. SUNSCREENS? • It has broad-spectrum coverage, successfully filtering UVA (320-440 nm) and UVB (290-320 nm) rays • Oxybenzone has many advantages over inorganic ingredients (TiO2 and ZnO). It is photostable, inexpensive, and easily spread on skin leading to greater acceptability. • Oxybenzone also overcomes the disadvantages of mineral filters, including minimal water-resistance, clumping, need for more frequent reapplication, and inability to achieve high SPFs without being cosmetically unacceptable due to deposition of a white cast on the skin

Mirsky et al, SKIN, 2018 Duplicate

Sunscreens and Oxybenzone 70+% of US sunscreens contain oxybenzone because it is: or • Inexpensive • Effective and broad spectrum • Does not impact on cosmetic acceptability

It is somewhat challenging to produce a cosmetically acceptable high SPF sunscreen without including oxybenzone

Mirsky et al, SKIN, 2018

Distribute Oxybenzone and Sunscreens: A Critical Review of the Evidence and a Plan for Discussion with Patients IS THERE DATA TO SUGEST THAT OXYBENZONE IS HARMFUL TO HUMANS? • Systemic absorption has been observed at a rate of 1% to 2% after topical application. However, the concentrations achieved by cutaneous penetration are too low to cause toxicity • Very high levels of oxybenzone were associated with estrogenic effects in rats. • To reach equivalent systemic concentrations of oxybenzone in humans, one would need to applyNot sunscreen at the FDA recommended density of 2 mg/cm2 to 100% body surface area daily for 35 years • Researchers also measured plasma concentrations of oxybenzone and reproductive hormones in men and women after application of 10% oxybenzone, finding no biologically significant differences in hormone levels • To date, there have been no clinically significant negative effects of oxybenzone in humans. Do Mirsky et al, SKIN, 2018

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Oxybenzone and Sunscreens: A Critical Review of the Evidence and Oxybenzone and Sunscreens: A Critical Review of the Evidence and a Plan for Discussion with Patients a Plan for Discussion with Patients IS OXYBENZONE THE REASON FOR CORAL BLEACHING? ARE THERE OTHER POTENTIAL PROBLEMS WITH OXYBENZONE RESTRICTIONS? • In-vitro experiments have found oxybenzone can cause coral bleaching at • Hawaii has one of the highest rates of skin cancer in the US making it surprising concentrations of 33-50ppm - artificial conditions not reflective of actual marine reef that this state chose to implement this law despite the Hawaii Medical ecosystems with levels much greater than those found in the ocean Association, many expert dermatologists, and sunscreen manufacturers all opposed the law. • Water sampled off the coasts of Hawaii and the US Virgin Islands have shown maximum oxybenzone concentrations of 0.019 and 1.4 ppm – materially less than those noted in • Other municipalities are considering following Hawaii in banning oxybenzone. the in-vitro study and therefore unlikely to cause harm. • Only 30% of sunscreens will be available to the population in Hawaii leading to a • Scientists believe that coral bleaching on the Great Barrier Reef has occurred as a direct potential increased future skin cancer risk in both residents and visitors. result of increased water temperatures from global warming • Spray formulations of sunscreen are rapidly becoming the most popular choice of • Locations where maximal coral bleaching has occurred do not correlate with where sunscreen users and creating oxybenzone-free sprays is difficult due to inherent humans populate. physical properties of inorganic sunscreen filters • There are no in-vivo studies that have shown oxybenzone to be directly causative in • Consumers may decide to forgo sunscreen based on unfounded fears that coral bleaching. “sunscreen is bad” and thus increase their skin cancer risk. Mirsky et al, SKIN, 2018 Mirsky et al, SKIN, 2018 Duplicate

Oxybenzone and Sunscreens: A Critical Review of the Evidence and Oxybenzone and Sunscreens: A Critical Review of the Evidence and a Plan for Discussion with Patients a Plan for Discussion with Patients HOW SHOULD DERMATOLOGISTS RECONCILE THE SCIENCE TO ADVOCATE FOR PATIENTS? WHAT IS A REASONABLE APPROACH TO DISCUSS THIS ISSUE WITH PATIENTS? • The current state of science does not appear to justify instituting an outright ban 1) There is strongor data to support sunscreen usage lowers skin cancer risk. on oxybenzone. 2) There is laboratory evidence to suggest oxybenzone has negative environmental • Misinformation and misinterpretation of studies that were not done in humans effects, but these experiments were not representative of real-world conditions or real-life environments led to this law. and thus results are inconclusive. • As dermatologists and physicians, we should strive to be patient centric and 3) If a patient is concerned about possible environmental effects, they may use continue our focus on lowering skin cancer incidence and mortality inorganic sunscreens, but they should be counseled about the associated disadvantages. • While we should encourage further research, the potential risks to patients by curtailing access to effective sunscreening agents must be seriously considered 4) Sunscreens are one part of a total sun-protection package that includes avoiding the midday sun and using sun-protective clothing. • Hypothetical environmental concerns alone should not detract dermatologists from continuing to educate their patients on the importance of sun protection 5) Understanding that the optimal sunscreen is one that patients will use consistently, keeping in mind cost and cosmetic acceptability. Mirsky et al, SKIN, 2018 Mirsky et al, SKIN, 2018

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AAD Sunscreen New measures of RecommendationsNot measuring sunscreen effectiveness

Do 156

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New non-invasive approach assessing in vivo SPF using A new approach for evaluating the water resistance of Diffuse Reflectance Spectroscopy and in vitro transmission sunscreens: Tap water vs. Salt water vs. Chlorine water • Seventeen test materials with known in vivo SPF values were • In-vivo screening approach to measure water resistance tested using UVA-induced fluorescence imaging • Combines the evaluation of UVA absorption spectrum as All testing performed on the forearms of 10 subjects using • measured by diffuse reflectance spectroscopy (DRS) with the UVA fluorescence imaging with tap, salt and chlorinated spectral absorbance "shape" of the UVB absorbance of test water. material as determined with in-vitro thin film spectroscopy • Method effective and also tests water specific sunscreens • Strong correlation of this new method with in vivo clinical SPF such as a beach dedicated product showing a 20% higher values r2 = 0.98 resistance to salt water versus tap and chlorine waters • Conclusion: • Conclusion: – This methodology provides a new approach to determine SPF – The use of UVA-induced fluorescence imaging on skin values without the extensive UV irradiation procedures (and proved a useful in-vivo approach for measuring the water biological responses) currently used to establish sunscreen efficacy resistance performance Puccetti et al, Int J Cosmet Sci, 2014 Ruvolo et al, Photodermatol Photoimmunol Photomed, 2014 Duplicate

Immune Protection Factor of Sunscreens Accumulated p53 protein and UVA Protection Levels in Sunscreen • UV exposure leads to decreased immune response in skin • 2or sunscreens (SPF 7 – PFA 3 or 7) tested • UV induced suppression of Nickel allergy • p53 levels measured in biopsies from UVA measure in subjects wearing sunscreen exposed skin • IPFs derived from the ratio of the minimal • Increased p53 with same exposure levels immune suppression dose (MISD) of UV in with lower UVA protection sunscreen applied sites vs. MISD of unprotected sites • Conclusions: Conclusions: – p53 levels could be a biologic measure – IPF can be used as a measure of UV protection of UVA protection

Damian et al, Photochem Photobiol, 1999 Seite et al, Photoderm Photoimmunol Photomed, 2000

Distribute Chemiluminescence Evidence of Free Radical Radical Sun Protection Factor - RSF Generation • Free radical formation from UV exposure in the skin measured in pig skin biopsies with electron Free Radical Generation After 20 J/cm2 UVA Irradiation spin resonance spectrometry Unirradiated 700 Baseline • Correlated with in-vivo measurements in human 600 Non-photostable Sunscreen skin 500 Untreated • The effectiveness of UV filters inversely 400Not Photostable 300 correlate with level of radical generation Sunscreen

Intensity (cps) Intensity 200 • Conclusions: 100 – Biophysical endpoint of free radical and 0 0 50 100 150 200 250 300 reactive oxygen species in skin (RSF) can Time (s) measure UV protection in sunscreens Chu M, Bargo P, Cole CA. Measurement of the reduction of UVA-induced oxidative stress after application of Do photostable sunscreens. 2004 Herrling et al, Spetrochim Acta A Mol Biomol Spectrosc, 2006

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DNA Dosimetry Assessment for Sunscreen Genotoxic Photoprotection Integrated Sun Protection Factor - IPF • Sun Protection Factor for DNA (DNA-SPF) is calculated by • Free radical formation occurs from UV, IR-A and using specific DNA repair enzymes, and it is defined as the visible light exposure in the skin capacity for inhibiting the generation of cyclobutane pyrimidine dimers (CPD) and oxidised DNA bases compared • Measured in skin biopsies with electron spin with unprotected control samples resonance X-band spectrometry • 5 commercial sunscreens and 17 sun protection formulations • Integrates radiation exposure effects in all skin were tested • layers • All of the commercial brands of SPF 30 sunscreens provided sufficient protection against simulated sunlight genotoxicity • Conclusions: • Conclusions: – Method effective for testing overall UV – DNA dosimeter is an alternative, complementary, and protection reliable method for the quantification of sunscreen photoprotection at the level of DNA damage Schuch et al, PLoS One, 2012 Zastrow et al, Skin Pharmacol Physiol, 2004 Duplicate

Topical Berry Extract with SPF Activity • In-vitro study of blackberry and raspberry extract found intrinsic SPF activityor • Raspberry = SPF 37, Blackberry = SPF 54 Augmenting • When incorporated into emulsions, the products were creamy and fruity in odor. Photoprotection • Conclusion: • Berry extracts can be potential natural alternatives to be used as sunscreen.

165 Cefali, et al. J Cosmet Dermatol. 2018.

Distribute Polypodium leucotomos extract (PLE): a status Polypodium leucotomos report on clinical efficacy and safety Decreases UV induced skin damage • Investigated Photoprotective effects of oral administration in 9 25 studies showing safety and efficacy patients • Measured erythema (MED) and biopsied skin and measured sunburn cells, pyrimidine dimers, dermal mast cell infiltration and Langerhans cells • All of theseNot measures were improved with the administration of polypodium • Conclusion: – Effective systemic chemoprotective agent against UV Conclusion: radiation exposure skin damage Current level of evidence suggests oral PLE can be prescribed confidently for long-term use Do Middelkamp-Hup et al, J Am Acad Dermatol. 2004 Winkelmann et al, J Drugs Dermatol. 2015

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Dermatologists’ Perceptions Recommendations and Usage of Sunscreen Dermatologists' Views 100% 100% 99% 99% 90% 97%

80%

70%

60%

50%

What do our colleagues think? 40%

30%

20%

10%

0% Lowers SkCA Risk Reduces photoaging Rec to friends/family Pts use too little

N = 156 169 Farberg et al, JAMA Dermatol. 2016 Duplicate

Dermatologists’ Perceptions Recommendations and Usage of Sunscreen Dermatologists’ Perceptions Recommendations and Usage of Sunscreen Dermatologists' Beliefs Dermatologists' Recommendation Factors 100% 100% 99% 90% 96% 97% 90% 96% 91% or 87% 80% 83% 80% 70% 70% 71% 60% 60%

50% 50%

40% 40% 42% 30% 30%

20% 20%

10% 10%

0% 0% Sunscreens safe Oxybenzone safe Retinyl palmitate High SPFs safety Recommend SPF level Broad spectrum Feel/elegance Photostability safe margin SPF50+ N = 156 N = 156 Farberg et al, JAMA Dermatol. 2016 Farberg et al, JAMA Dermatol. 2016

Distribute MoreSPF Years Recommendation in Practice, More Likely By Years to Recommend in Practice High SPF 100% 6% 7% 8% 8% 12% 11% 10% 16% 16% 15% 80% 23%

60%

88% 79% 40% 72% 72% 73% The more fundamental issue… Not 63%

20%

4% 4% 0% 4% 4% 4% Overall 0-5 years 5-10 years 10-20 years 20-30 years 30+ years SPF 70+ SPF 50-69 SPF 30-49 SPF 15-29 SPF <15 Do 174

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Beachgoers Frequently Report Painful Sunburns • Survey of beachgoers (N=1054) assessed behaviors, attitudes, and knowledge related to sun exposure at the beach • 19% of respondents had sunbathed for >30 days in the past year and 17% reported >3 hours of sun exposure per day • 47% of respondents reported 1 or more painful sunburns during the previous summer • Independent predictors for sunburn were male gender, age <30, higher education, skin type I-III, sun exposure at midday • Conclusion: • Beachgoers are a high risk population for sunburn and thus future skin cancers. Education efforts should discourage midday sun exposure, changing attitudes towards tanning, and improved knowledge of skin cancer. de Troya-Martin, et al. Photodermatol Photoimmunol Photomed. 2018. Duplicate

Poor Public Understanding of Sunscreen Labeling Poor Public Understanding of Sunscreen Labeling • Survey of dermatology patients on sunscreen use and knowledge 100% of FDA-mandated labeling or 80%

• N=334, 68% female, majority rarely applied sunscreen Incorrect 60% understanding • Answered questions on concepts of SPF, broad spectrum, and 60% waterproof 40% Correct understanding • “What does ‘SPF’ on sunscreen labels represent?” 20% 28% • “In reference to sunscreen, what does ‘broad-spectrum’ mean?” 31%

• “Can sunscreen be waterproof?” 0% SPF? Broad-Spectrum? Waterproof?

Prado et al. Photodermatol Photoimmunol Photomed. 2018. Prado et al. Photodermatol Photoimmunol Photomed. 2018.

Distribute Poor Public Understanding of Sunscreen Labeling Poor Public Understanding of Sunscreen Labeling

80% 40% 70% 31% 31% 60% 57% 29%

Hx of Skin CA 43%* 40% 20% 34% NO Hx of Skin CA Not26% 28% 20% 9% * P=0.032

0% 0% SPF? Broad-Spectrum? Waterproof? 0123 Number correctly answered Mean = 1.2 Do Prado et al. Photodermatol Photoimmunol Photomed. 2018. Prado et al. Photodermatol Photoimmunol Photomed. 2018.

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Poor Public Understanding of Sunscreen Labeling Poor Public Understanding of Sunscreen Labeling 60% • Pts with personal h/o skin cancer 3x more likely to answer at least 1 question correctly 43% 40% • Older pts and darker skin type more likely to answer all questions Hx of Skin CA 32% 33% Mean = 1.46 incorrectly 27% 27% NO Hx of Skin CA • Conclusion: 19% Mean = 1.11 20% 11% • General understanding of sunscreen labeling is poor. 8% Overall difference • Most patients did not comprehend the key features of FDA- 0% P=0.032 mandated sunscreen labeling. 0123 Number correctly answered • Educational programs are needed to address this knowledge gap. Prado et al. Photodermatol Photoimmunol Photomed. 2018. Prado et al. Photodermatol Photoimmunol Photomed. 2018. Duplicate

Despite Decades of Science, Education, Sunscreen Compliance is Low High SPF is proven to offer clinically significantor benefits in real-world settings and Only 30% actual use scenarios of women and >15% of men use sunscreen on face and exposed skin1

Discuss value of High SPF sunscreens for: Only 39.1% • patients who under-apply of American households purchase sunscreen2 • acute and long-term exposure • extended outdoor activity

1American Academy of Dermatology survey, May 2015 2Source: IRI, US Sunscreen Household Penetration, 52 weeks ending 6/29/2014, all major retail outlets

Distribute Meeting the challenges of Photoprotection Summary • Photoprotection important and lowers Skin Cancer risk • Higher SPFs have been proven to have clinical benefits to users • Dermatologists are recommending higher SPFs • UnderstandingNot oxybenzone issues and being able to discuss with pts • Knowledge gap in the public on sunscreen understanding • Have to improve getting the message to our pts – especially in Dothe importance of high SPFs

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Duplicate

A Multidisciplinary Approach to Cutaneous or Squamous Cell Carcinoma Today @5PM Royal Palm 4-5

Darrell S. Rigel, MD MS Clinical Professor of Dermatology New York University Medical Center New York, NY

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Sun Care Habits Among Aquatic Athletes • Aquatic athletes (N=240) answered questions on sun protection, sun exposure, and sports habits • On average, 76% of respondents had experienced a sunburn in the last season and 27% had experienced 3+ sunburns • The majority had not visited a doctor for a skin check (67-91%) or practiced self-examination (67-98%) • Conclusion: • In this population, there is a general lack of awareness of skin cancer risk. We need to raise awareness of the dangers of sun exposure, through educational interventions on the importance of protecting against sunburn in order to reduce the future incidence of skin cancer.

De Castro-Maqueda, et al. J Cancer Educ. 2019. Duplicate

Beachgoers Frequently Report Painful Sunburns • Survey of beachgoers (N=1054) assessed behaviors, attitudes, and knowledge related to sun exposure at the beach or • 19% of respondents had sunbathed for >30 days in the past year and 17% reported >3 hours of sun exposure per day • 47% of respondents reported 1 or more painful sunburns during the previous summer • Independent predictors for sunburn were male gender, age <30, higher education, skin type I-III, sun exposure at midday • Conclusion: • Beachgoers are a high risk population for sunburn and thus future skin cancers. Education efforts should discourage midday sun exposure, changing attitudes towards tanning, and improved knowledge of skin cancer. de Troya-Martin, et al. Photodermatol Photoimmunol Photomed. 2018.

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