Resident Corner

Simplifying Safety: A Guide to the New FDA Monograph

Roman Bronfenbrener, MD

Dermatologists are instrumental in educating their but will resolve the discrepancies between the derma- patients about safe sun practices. As residents, tologist’s recommendations and the sunscreen label’s we should begin to instill this teaching point into claims of efficacy. our daily patient encounters. The new US Food and Drug Administration sunscreen guidelines, Claims of Broad-Spectrum Efficacy instituted fully in December 2012, help consumers Sun protection factor (SPF) is a ratio that indicates make more educated decisions about how much UVB protection is afforded by a sunscreen. they purchase but also introduce new classifi- For instance, an SPF of 10 allows for 10 times more cations and claims with which dermatologists UVB to contact the skin before a given amount of should be intimately familiar.CUTIS This article aims to erythema is reached; therefore, if a patient normally concisely summarize the revisions as well as any burns in 5 minutes, properly applied SPF 10 sunscreen continued controversies with the guidelines. will prolong the burn time to 50 minutes. Previously, Cutis. 2014;93:E17-E19. consumers relied only on SPF values to determine their sunscreen’s efficacy, which is a serious flaw considering UVA protection is not factored into SPF. ou can always pick out the dermatologists on Exposure to UVA has been shown to increase the Dothe beach, donning wide-brimmedNot hats and risk for Copy skin cancer, and its deeper dermal penetra- sun-protective and setting egg timers tion with resultant elastolysis is partially responsible Y 2,3 for sunscreen reapplication. The long-term benefits for skin aging. The ideal sunscreen would provide of UV protection have been instilled in our brains uniform coverage against the entire UVA and UVB from early in our residency training. Sunscreen is an range, and the new guidelines allow for manufacturers invaluable tool in this armamentarium and provides to place the broad-spectrum designation on products an easily applied method of sun protection that can that function in this manner.4 The degree of UVA be used daily. Prior to the new US Food and Drug protection offered by a sunscreen is measured with in Administration (FDA) guidelines, whose compliance vitro testing of the critical wavelength (370 nm). A deadline passed in December 2012,1 sunscreen mar- sunscreen must have 90% of its absorbance at 370 nm keting and labeling allowed for wide discrepancies or greater to meet minimum UVA-blocking require- between manufacturers’ claims of efficacy and actual ments for classification as broad spectrum.5 consumer experience. These better-defined guidelines will not only help patients find a suitable sunscreen Usage Claims Sunscreens that meet the requirements for being considered broad spectrum and are rated SPF 15 or higher can now be labeled with several FDA- From the Department of Dermatology, State University of approved claims. These claims, which state that sun- New York, Stony Brook. screen use can not only reduce the risk for skin cancer The author reports no conflict of interest. Correspondence: Roman Bronfenbrener, MD, 181 N Belle Mead but also decrease signs of sun-induced skin aging, Rd, Suite 5, East Setauket, NY 11733 are in line with dermatologist recommendations. ([email protected]). Allowing companies to put these claims on products

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incentivizes better sunscreen manufacturing and such as seeking shade during peak hours (between encourages patient compliance.4 10 am and 2 pm) and wearing appropriate sun- protective clothing and eyewear.6 Resiliency Claims Prior to these recent guidelines, many sunscreen Vehicle for Sunscreen manufacturers made various unsubstantiated claims The new FDA monograph only pertains to products of resiliency and durable efficacy, even under extreme in certain formulations. Products designed as pow- conditions. Many sunscreen labels frequently touted ders, shampoos, and bodywashes are not included, products as being waterproof and/or sweatproof. as they have questionable efficacy, especially in real- Although certain sunscreens are more efficacious world applications. Companies can individually seek in high-moisture environments, the new guidelines to monograph their product, which would be done restrict claims of water resistance to times of either on a case-by-case basis and requires manufacturers of 40 or 80 minutes, a stark contrast from some prior new or novel sunscreen formulations to prove their claims that promised all-day protection.4 Sunscreens efficacy to the FDA when used as directed before they not labeled as water resistant are required to suggest will receive approval for marketing as a sunscreen.4 the use of a water-resistant sunscreen during wet activities such as swimming or sweating on the drug Final Thoughts information label. Labels also are required to state Although these guidelines benefit consumers in many that sunscreen should be reapplied at least every ways, they do not address all the concerns associated 2 hours, after towel drying, and more frequently when with sunscreen; for instance, the regulations make swimming or sweating (Figure).6 no final decision regarding spray sunscreens whose efficacy has shown substantial variation between in- Sunscreens Are Only a Single Component vitro testing and real-world application by consumers. of Sun-Safe Practice Similarly, controversy regarding potential inhala- Although sunscreen is an invaluable component of tion of sunscreen products in aerosol form has not sun protection, it is only one piece of a puzzle and been addressed. should not be considered theCUTIS only, or even the best, Another focus of attention is the maximum SPF form of protection against UV damage. New sun- rating to be allowed by the FDA. The FDA is propos- screen labels reinforce this notion with practical tips, ing a limit on the maximum SPF at 50,7 a measure

Sunscreen Labeling According to Drug Facts Do2011 Final RuleNot Copy Active Ingredients Purpose 3% Sunscreen If used as directed with other sun 10% 7.5% } protection measures, this product Uses reduces the risk of skin cancer • helps prevent and early skin aging, as well as • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun helps prevent sunburn. Warnings Only products labeled with both For external use only "Broad Spectrum" AND SPF15 or Do not use on damaged or broken skin higher have been shown to When using this product keep out of eyes. Rinse with water to remove. provide all these benefits. Stop use and ask a doctor if rash occurs Keep out of reach of children. If product is swallowed, get medical BRAND help or contact a Poison Control Center right away. Sunscreen Directions • apply liberally 15 minutes before sun exposure • reapply: • after 40 minutes of swimming or sweating X • immediately after towel drying

X • at least every 2 hours

BROAD SPECTRUM • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use SPF 15 a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. – 2 p.m. • wear long-sleeve shirts, pants, hats, and • children under 6 months: Ask a doctor Example of new product label Inactive ingredients according to the US Food and Drug aloe extract, barium sulfate, benzyl alcohol, carbomer, dimethicone, disodium EDTA, jojoba oil, methylparaben, octadecene/MA Administration monograph with copolymer, polyglyceryl-3 distearate, phenethyl alcohol, propylparaben, WATER RESISTANT sorbitan isostearate, sorbitol, stearic acid, tocopherol (vitamin E), updated recommendations for use (40 MINUTES) triethanolamine, water Other information and efficacy claims for sunscreens. • protect this product from excessive heat and direct sun (This figure is in the public domain, 6.0 FL OZ (180 mL ) Questions or comments? courtesy of the US Food and Call toll free 1-800-XXX-XXXX Drug Administration.6)

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already undertaken by both European and Australian prefers. It will be important to stay abreast of new regulatory bodies. Proponents for this regulation argue developments, as further FDA decisions as well as that sunscreens with higher SPF ratings expose the exciting technological advances will continue to skin to higher concentrations of potentially irritating change the face of sun protection. or sensitizing chemicals while only minimally raising the percentage of UVB blocked. Higher SPF numbers REFERENCES also provide false security to consumers who may 1. Labeling and effectiveness testing; sunscreen drug prod- apply the product less frequently and decrease their ucts for over-the-counter human use; delay of compliance use of other sun protective measures.8 As a counter- dates. Fed Regist. 2012;77(92):27591-27593. To be codified point, allowing higher SPF sunscreens may actually at 21 CFR §201 and 310. protect consumers because many do not apply their 2. Understanding UVA and UVB. Skin Cancer Foundation product at the same 2 mg/cm2 used in the laboratory Web site. http://www.skincancer.org/prevention/uva-and to determine SPF and UVA-blocking parameters. -uvb/understanding-uva-and-uvb. Accessed February 28, 2014. Higher SPF sunscreens would therefore allow greater 3. Wang S, Setlow R, Berwick M, et al. A and protection in real-world use, as compared to marginal : a review. J Am Acad Dermatol. 2001;44: differences in the laboratory setting.6,8 837-846. Finally, it is important to remain vigilant about 4. FDA sheds light on sunscreens. US Food and Drug our patients’ concerns, many relating to prevalently Administration Web site. http://www.fda.gov/forconsum- held beliefs regarding safety of various sunscreen ers/consumerupdates/ucm258416.htm. Updated August components as well as vitamin D synthesis. Although 20, 2013. Accessed March 1, 2014. the FDA is unlikely to address these issues in its 5. What is Critical Wavelength® anyway? Critical Wavelength monographs, our job as dermatologists is to continue Web site. http://criticalwavelength.com/CRITICAL to educate our patients to ensure they make rational, _WAVELENGTH_.html. Accessed February 24, 2014. science-based decisions with regard to their sun pro- 6. Sunscreen labeling according to 2011 final rule. US tection habits. Food and Drug Administration Web site. http://www On the whole, these recently implemented guide- .fda.gov/downloads/ForConsumers/ConsumerUpdates lines are invaluable in enlighteningCUTIS consumers and /UCM258718.pdf. Accessed February 7, 2014. encouraging educated purchases. Prior unconfirmed 7. Revised effectiveness determination; sunscreen statements made by sunscreen marketers on prod- drug products for over-the-counter human use. Fed uct labels and advertising have been replaced by Regist. 2011;76(117):35672-35678. To be codified at evidence-based claims that are consistent across the 21 CFR §201. entire range of sunscreen products. These regulations 8. Wang SQ. Ask the expert: does a higher-SPF (sun protec- also simplify the recommendations we make to our tion factor) sunscreen always protect your skin better? Skin patients.Do Currently, I recommend Not that my patients CancerCopy Foundation Web site. http://www.skincancer.org use a broad-spectrum product with an SPF of 30 or /skin-cancer-information/ask-the-experts/does-a-higher- higher; if the sunscreen meets these criteria, I am spf-sunscreen-always-protect-your-skin-better. Accessed satisfied with any brand or vehicle that the patient March 1, 2014.

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