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Sun Protection, Sunscreens and Vitamin D
SunSun protection,protection, sunscreenssunscreens andand VitaminVitamin DD GPGP NationalNational ConferenceConference RotoruaRotorua EnergyEnergy EventsEvents CentreCentre JuneJune 20092009 Dr. Louise Reiche Dermatologist New Zealand Dermatological Society Incorporated MelanomaMelanoma SkinSkin cancercancer andand sunlightsunlight Exposure to UVR causes > 90% of skin cancers Skin cancer is commonest cancer in NZ >50,000 new cases per year ~300 deaths per year ~$33.4 NZ million per year International Agency for Research on Cancer. IARC Monographs on the evaluation of carcinogenic risks to humans. Solar ultraviolet radiation. Lyon: International Agency for Research on Cancer, 1992. Armstrong BK. How sun exposure causes skin cancer. In: Hill D, Elwood JM, English DR, Eds. Prevention of Skin Cancer. Dordrecht: Kluwer Academic Publishers, 2004. O’Dea D. The Costs of Skin Cancer to New Zealand. Wellington: Cancer Society of New Zealand, 2000. New Zealand Health Information Service. Cancer, New Registrations and Deaths. Wellington: New Zealand Health Information Service, 2004. MelanomaMelanoma 1842 new cases in 2002 328 directly attributable to severe sunburn (Sneyd and Cox 2006) Authors recommended, “to reduce burden of melanoma in NZ, need to prevent excessive sun exposure and (facilitate) early diagnosis” Whilst cancer overall is rare in adolescence, melanoma was commonest cancer MelanomaMelanoma NZ incidence and death rate among world highest 56.2/100,000 in European population of Auckland highest reported worldwide men -
FDA Proposes Sunscreen Regulation Changes February 2019
FDA Proposes Sunscreen Regulation Changes February 2019 The U.S. Food and Drug Administration (FDA) regulates sunscreens to ensure they meet safety and eectiveness standards. To improve the quality, safety, and eectiveness of sunscreens, FDA issued a proposed rule that describes updated proposed requirements for sunscreens. Given the recognized public health benets of sunscreen use, Americans should continue to use broad spectrum sunscreen with SPF 15 or higher with other sun protective measures as this important rulemaking eort moves forward. Highlights of FDA’s Proposals Sunscreen active ingredient safety and eectiveness Two ingredients (zinc oxide and titanium dioxide) are proposed to be safe and eective for sunscreen use and two (aminobenzoic acid (PABA) and trolamine salicylate) are 1 proposed as not safe and eective for sunscreen use. FDA proposes that it needs more safety information for the remaining 12 sunscreen ingredients (cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, avobenzone). New proposed sun protection factor Sunscreen dosage forms (SPF) and broad spectrum Sunscreen sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks are requirements 2 proposed as safe and eective. FDA 3 • Raise the maximum proposed labeled SPF proposes that it needs more data for from SPF 50+ to SPF 60+ sunscreen powders. • Require any sunscreen SPF 15 or higher to be broad spectrum • Require for all broad spectrum products SPF 15 and above, as SPF increases, broad spectrum protection increases New proposed label requirements • Include alphabetical listing of active ingredients on the front panel • Require sunscreens with SPF below 15 to include “See Skin Cancer/Skin Aging alert” on the front panel 4 • Require font and placement changes to ensure SPF, broad spectrum, and water resistance statements stand out Sunscreen-insect repellent combination 5 products proposed not safe and eective www.fda.gov. -
Chemical UVR Absorbers
Chemical UVR Absorbers The names given in bold and used Diisopropyl methyl cinnamate Glyceryl ethyihexanoate dimethoxy- throughout this handbook are those of Empirical formula: cinnamate the International Nomenclature of C 6H22O2 Chemical names. Cosmetic Ingredients. Glyceryl octanoate dimethoxycinnamate; Chemical names: 2-propenoic acid, 3-(4-methoxyphenyl)-, 2-Propenoic acid, 3-12,4bis(1 diester with 1 ,3-dihydroxy-2-(2-ethyl-1 - methylethyphenyl-methyl ester; 2,5- oxohexyl)oxypropane diisopropyl methyl cinnamate _ lsoamyl-para-methoxycinnamate Ethyihexyl methoxycinnamate Empirical formula: Empirical formula: C151-12003 C 8H26O3 Chemical names: Cinnamates Chemical names: Amyl4-methoxycinnamate; isopentyl-4- 2-Ethylhexyl-4-methoxycin nam ate; methoxycinnamate; isopenlyl-para- Cinoxate 2-ethyl-hexyl-para-methoxycinnamate; methoxy-cinnamate; 3-(4-methoxyphenyl)- Empirical formula: para-methoxycinnamic acid, 2-ethylhexyl 2-propenoic acid, isopentyl ester Ci4HieO4 ester; 3-(4-methoxyphenyl)-2-propenoic acid, 2-ethylhexyl ester; octinoxate; octyl Trade names: Chemical names: methoxycinnamate; 2-propenoic acid, 3- Neo Heliopan type E 1000; Solarum AMC 2- Ethoxyothyl-para-methoxyci n nam ate; (4-methoxyphenyl)-2-ethylhexyl ester 2-propenoic acid, 3-(4-methoxyphery- para-A minobenzoic acids (PA BAs) 2-ethoxyethyl ester; 2-ethoxyethyl-4- Trade names: methoxycinnamate AEC Octyl Methoxycinnamate; Escalol Amyl dimethyl FABA 557; Eusolex 2292; Heliosol 3; Empirical formula: Trade names: Jeescreen OMC; Katoscreen OMC; Nec C14H21 NO2 Giv Tan F; Phiasol -
United States Patent (19) 11 Patent Number: 6,086,858 Mceleney Et Al
US006086858A United States Patent (19) 11 Patent Number: 6,086,858 McEleney et al. (45) Date of Patent: *Jul. 11, 2000 54). COLORED FORMULATIONS FOR 4,818,491 4/1989 Fariss. APPLICATION TO HUMAN SKIN 4.954,544 9/1990 Chandaria. 5,426.210 6/1995 Kato et al.. 75 Inventors: John McEleney, Newton; Wende SS 8.1. R el, Restry BMS Curtis A. Vock, 5,562,8962- - -2 10/1996 Repperepper et al..al. s 5,567,420 10/1996 McEleney et al. ....................... 424/60 5,609,852 3/1997 Galley et al.. 73 Assignee: IPA, LLC, Forth Worth, Tex. 5,753,210 5/1998 McEleney et al. ....................... 424/59 c: 5,955,062 9/1999 McEleney et al. ... ... 424/59 * Notice: This patent is Subject to a terminal dis- 5,958,383 9/1999 McEleney et al. ....................... 424/59 CC. OTHER PUBLICATIONS 21 Appl. No.: 09/333,088 Deposition Transcript of Jack Katz, Feb. 10, 1999, pp. 1-32, 22 Filled: 15, 1999 regarding civil action entitled, Playtex Products, Inc. and 22 File Jun. 15, Sun Pharmaceuticals Corporation vs. Schering-Plough Related U.S. Application Data Healthcare Products, Inc., Case No. 98–482-RPM, United States District Court, Middle District of Delaware. 63 Continuation of application No. 09/217,170, Dec. 21, 1998, First Amended Complaint, IPA v Schering-Plough et al., which is a continuation of application No. 09/024,458, Feb. Civil Action No. 98–482 (RRM), Jan. 22, 1999, 14 pages. ship, alengageplain E. Defendants' Answer & Counterclaims to First Amended ation of application N. Soss 64. -
Salicylate UV-Filters in Sunscreen Formulations Compromise the Preservative System Efficacy Against Pseudomonas Aeruginosa and Burkholderia Cepacia
cosmetics Article Salicylate UV-Filters in Sunscreen Formulations Compromise the Preservative System Efficacy against Pseudomonas aeruginosa and Burkholderia cepacia Noa Ziklo, Inbal Tzafrir, Regina Shulkin and Paul Salama * Innovation department, Sharon Laboratories Ltd., Odem St. Industrial zone Ad-Halom, Ashdod 7898800, Israel; [email protected] (N.Z.); [email protected] (I.T.); [email protected] (R.S.) * Correspondence: [email protected]; Tel.: +972-54-2166476 Received: 15 July 2020; Accepted: 1 August 2020; Published: 3 August 2020 Abstract: Contamination of personal-care products are a serious health concern and therefore, preservative solutions are necessary for the costumers’ safety. High sun protection factor (SPF) sunscreen formulations are known to be difficult to preserve, due to their high ratio of organic phase containing the UV-filters. Salicylate esters such as octyl salicylate (OS) and homosalate (HS) are among the most common UV-filters currently used in the market, and can undergo hydrolysis by esterase molecules produced by contaminant microorganisms. The hydrolysis product, salicylic acid (SA) can be assimilated by certain bacteria that contain the chorismate pathway, in which its final product is pyochelin, an iron-chelating siderophore. Here, we show that OS and HS can compromise the preservative efficacy against two pathogenic important bacteria, Pseudomonas aeruginosa and Burkholderia cepacia. Challenge tests of formulations containing the UV-filters demonstrated that only bacteria with the chorismate pathway failed to be eradicated by the preservation system. mRNA expression levels of the bacterial pchD gene, which metabolizes SA to produce pyochelin, indicate a significant increase that was in correlation with increasing concentrations of both OS and HS. -
Ultraviolet Radiation
Environmental Health Criteria 160 Ultraviolet Radiation An Authoritative Scientific Review of Environmental and Health Effects of UV, with Reference to Global Ozone Layer Depletion V\JflVV ptiflcti1p cii ii, L?flUctd EnrrcmH Prormwe. Me World Haah6 Orgniri1ion and Fhc nIrrHbccrlT Ornrn)is5ion on Nfl-oflizirig Raditiori Prioiioii THE Ef4VIRONMEF4FAL HEALTH CI4ITERIA SERIES Acetonitrile (No. 154, 1993) 2,4-Dichloroplierioxyaceric acid (2 4 D) (No 29 Acrolein (No 127, 1991) 1984) Acrylamide (No 49, 1985) 2,4.Dichlorophenoxyucetic acd - erivirorrmerrtul Acr5lonilrile (No. 28, 1983) aspects (No. 54, 1989) Aged population, principles for evaluating the 1 ,3-Dichloroproperte, 1,2-dichloropropane and effects of chemicals (No 144, 1992) mixtures (No. 146, 1993( Aldicarb (No 121, 1991) DDT and its derivatives (No 9 1979) Aidrin and dieldrin (No 91 1989) DDT and its derivatives - environmental aspects Allethrins (No 87, 1989) (No. 83, 1989) Alpha-cypermethrirr (No 142, 1992) Deltamethrin (No 97, 1990) Ammonia (No 54, 1985) Diamirrotoluenes (No 74, 1987( Arsenic (No 18. 1981) Dichiorsos (No. 79, 1988) Asbestos and other natural mineral fibres Diethylhexyl phthalate (No. 131, 191112) (No. 53, 198€) Dirnethoate (No 90, 1989) Barium (No. 137 1990) Dimethylformnmde (No 114, 1991) Benomy( (No 143, 1993) Dimethyf sulfate (No. 48. 1985) Benzene (No 150, 1993) Diseases of suspected chemical etiology and Beryllium (No 106, 1990( their prevention principles of studies on Biommkers and risk assessment concepts (No. 72 1967) and principles (No. 155, 1993) Dilhiocarbsmats pesticides, ethylerrvthiourea, and Biotoxins, aquatic (marine and freshmaterl propylerrethiourea a general introdUCtiori (No 37, 1984) NO. 78. 1958) Butanols . four isomers (No. 65 1987) Electromagnetic Fields (No 1 '37 19921 Cadmiurrr (No 134 1992) Endosulfan (No 40. -
EWG Petitions CDC to Conduct Biomonitoring Studies for Common Sunscreen Chemicals
EWG Petitions CDC To Conduct Biomonitoring Studies for Common Sunscreen Chemicals May 22, 2019 To: U.S. Department of Health and Human Services Centers for Disease Control and Prevention National Center for Environmental Health Agency for Toxic Substances and Disease Registry 4770 Buford Hwy, NE Atlanta, GA 30341 Patrick Breysse, Ph.D., CIH Environmental Working Group (EWG), a nonprofit research and advocacy organization with headquarters in Washington, D.C., is petitioning the Centers for Disease Control and Prevention to add common sunscreen chemicals to the CDC’s Biomonitoring Program. EWG has been doing research on sunscreen ingredients since 2007, helping to educate the public about the importance of using sunscreens for health protection, as well as providing information about health risks that may be associated with certain ingredients used in sunscreen products. In response to a significant increase in the use of sunscreens in the United States and the associated increased potential for systemic exposure to the ingredients in these products, in February 2019, the Food and Drug Administration proposed a new rule for sunscreen products.1 The proposed rule would require sunscreen active ingredients to be assessed for their propensity to absorb through the skin and overall safety. Recently, the FDA completed tests on the absorbance of four common sunscreen active ingredients: avobenzone, oxybenzone, octocrylene, and ecamsule. As reported in a study published by the Journal of American Medical Association in May 2019,2 application of all four tested sunscreen ingredients resulted in plasma concentrations that exceeded the 0.5 ng/mL threshold proposed by the FDA for waiving systemic carcinogenicity studies as well as developmental and reproductive toxicity studies. -
Sun Protection
[ Oncology Watch] Sun Protection: What We and Our Patients Need to Know To preserve their health and the appearance of their skin, patients need straight- forward, practical advice on susncreen selection and protection strategies. By Jonathan Wolfe, MD rom preventing skin cancer to pre- measures protection against cutaneous burning. Even a FDA public education serving a youthful appearance, burning—the effects of UVB—and does piece states, “A higher number means it Fsunscreens play an important role not account for UVA radiation at all.5 As protects longer.”7 This is not a strictly in dermatologic care. However, some a result, a product with a high SPF could accurate interpretation of the SPF value confusion persists among patients and actually confer little or no protection and ignores the fact that unique proper- even some practitioners when it comes to against UVA. ties of the main sunscreen ingredients SPF, available chemical and physical sun- The somewhat esoteric description of (chemical or physical) and the formula- screens, and the best advice for sun SPF calculation is available online at the tion (waterproof, water resistant) influ- avoidance. In recognition of the AAD’s FDA website.6 Ultimately, the SPF num- ence duration of protection. Skin Cancer Detection and Prevention ber represents the ratio of the MED for Patients also often falsely assume that Month, I’ll review important patient protected skin (MED(PS)) to the MED the increase in SPF value is proportion- education points. for unprotected skin (MED(US)). Tests ate to the increase in UVB protection. It are conducted only in patients with skin is not. -
Determination of Sun Protection Factor (SPF) of Sunscreens by Ultraviolet Spectrophotometry
Revista Brasileira de Ciências Farmacêuticas Brazilian Journal of Pharmaceutical Sciences vol. 40, n. 3, jul./set., 2004 Determination of sun protection factor (SPF) of sunscreens by ultraviolet spectrophotometry Elizângela Abreu Dutra, Daniella Almança Gonçalves da Costa e Oliveira, Erika Rosa Maria Kedor- Hackmann*, Maria Inês Rocha Miritello Santoro Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo Uniterms: The aim of this research was to determine the sun protection factor • Sunscreens (SPF) of sunscreens emulsions containing chemical and physical • Cosmetic products sunscreens by ultraviolet spectrophotometry. Ten different • Sun protection factor commercially available samples of sunscreen emulsions of various • UV spectrophotometry manufactures were evaluated. The SPF labeled values were in the *Correspondence: range of 8 to 30. The SPF values of the 30% of the analyzed E. R. M. Kedor-Hackmann samples are in close agreement with the labeled SPF, 30% presented Departamento de Farmácia Faculdade de Ciências Farmacêuticas – SPF values above the labeled amount and 40% presented SPF UPS values under the labeled amount. The proposed spectrophotometric Av. Prof. Lineu Prestes, 580 – Bloco 13 – Cidade Universitária method is simple and rapid for the in vitro determination of SPF 05508-900 - São Paulo – SP – Brazil values of sunscreens emulsions. E-mail: [email protected] INTRODUCTION and is responsible for the damage due to sunburn. UVA radiation reaches the deeper layers of the epidermis and The rapid growth of commercially available products dermis and provokes the premature aging of the skin. containing sunscreens indicates that even though a suntan Ultraviolet radiations have been implicated as a causative is still desired, people are conscious of the possible dangers factor of skin cancer. -
Sun Protection
DRUG NEWS Recommending the Best Sun Protection Clinical Pearls: o Recommend a “broad-spectrum” sunscreen – one that covers UVB, UVA1, and UVA2. o Recommend SPF 30-50 o Advise on non-pharmacological sun protection methods o Emphasize proper sunscreen application technique o Emphasize skin protection when taking drugs known to cause photosensitivity. Familiarize yourself with known implicated drugs by referring to appendix 2. Background 1-4 The sun emits 3 types of ultraviolet (UV) radiation: UVC (100-290 nm), UVB (290-320 nm), and UVA (320 -400 nm). UVA rays can be further divided into the shorter UVA2 rays and the longer UVA1 rays. UVC rays, the shortest rays, are completely absorbed by the ozone layer, whereas UVB rays penetrate the epidermis and UVA rays, the longest rays, penetrate into the dermis. The main consequence of UVB irradiation is sunburn, but can also include immunosuppression and skin cancer. Consequences of UVA radiation include: phototoxicity (i.e. involvement in drug-induced sun sensitivity reactions), photo-aging, immunosuppression, and skin cancer. What is SPF? 2,5,6,7 It is easy to be misled by Sun Protection Factors (SPF). SPF is assessed through a standardized test by finding the ratio of the minimal dose of solar radiation that produces perceptible erythema (i.e., minimal erythema dose) on sunscreen-protected skin compared with unprotected skin. Sunburn is caused primarily by UVB rays (and shorter UVA2 rays), and thus SPF indicates mostly UVB protection. However, UVA protection is equally important since it is responsible for photo-aging and cancer. Therefore, it is important to look for the phrase “broad spectrum” when choosing a sunscreen as broad spectrum indicates both UVB and UVA protection. -
Food and Drug Administration, HHS § 352.20
Food and Drug Administration, HHS § 352.20 (c) Cinoxate up to 3 percent. than 2 to the finished product. The fin- (d) [Reserved] ished product must have a minimum (e) Dioxybenzone up to 3 percent. SPF of not less than the number of (f) Homosalate up to 15 percent. sunscreen active ingredients used in (g) [Reserved] the combination multiplied by 2. (h) Menthyl anthranilate up to 5 per- (2) Two or more sunscreen active in- cent. gredients identified in § 352.10(b), (c), (i) Octocrylene up to 10 percent. (e), (f), (i) through (l), (o), and (q) may (j) Octyl methoxycinnamate up to 7.5 be combined with each other in a single percent. product when used in the concentra- (k) Octyl salicylate up to 5 percent. tions established for each ingredient in (l) Oxybenzone up to 6 percent. § 352.10. The concentration of each ac- (m) Padimate O up to 8 percent. tive ingredient must be sufficient to (n) Phenylbenzimidazole sulfonic contribute a minimum SPF of not less acid up to 4 percent. than 2 to the finished product. The fin- (o) Sulisobenzone up to 10 percent. ished product must have a minimum (p) Titanium dioxide up to 25 percent. SPF of not less than the number of (q) Trolamine salicylate up to 12 per- sunscreen active ingredients used in cent. the combination multiplied by 2. (r) Zinc oxide up to 25 percent. (b) Combinations of sunscreen and skin [64 FR 27687, May 21, 1999] protectant active ingredients. Any single sunscreen active ingredient or any per- EFFECTIVE DATE NOTE: At 67 FR 41823, June mitted combination of sunscreen ac- 20, 2002, § 352.10 was amended by revising tive ingredients when used in the con- paragraphs (f) through (n), effective Sept. -
United States Patent (19) 11 Patent Number: 4.959,205 Brunner Et Al
United States Patent (19) 11 Patent Number: 4.959,205 Brunner et al. 45 Date of Patent: Sep. 25, 1990 54 COMPOSTION AND METHOD FOR TREATMENT OF DERMAL FOREIGN PATENT DOCUMENTS NFLAMMATION 1539625 6/1976 United Kingdom . OTHER PUBLICATIONS (75) Inventors: Maureen Brunner, San Francisco; Howard Palefsky, Atherton, both of The Merck Index, 1976, 9th edition, pp. 629 and 630. Calif. B. Ljunggren et al, Arch Derm Forsch (1973)248:1-12. J. P. Callen et al, Arthritis Rheum (Aug. 1988) 31:1007-13. (73) Assignee: Collagen Corporation, Palo Alto, L. H. Kligman, J Invest Dermatol (1987) 88:12s-17s. Calif. A. D. Pearse et al, J Invest Dermatol (1987) 88:83-87. M. Pathak, Dermatologic Clin (1986) 4:321-34 (Pathak 21 Appl. No.: 327,488 I). M. Pathak et al, J Amer Acad Dernatol (1986) 22 Filed: Mar. 23, 1989 15:894-99, T. Schwartz et al, Dermatologica (1985) 171:450-58. (51) Int. Cl. ......................... A61K 7/40; A61K 7/42; L. E. Gibson et al, Geriatrics (1985) 40:87-92. A61K 31/56 K. Kyuki et al, JapJ Pharmacol (1983) 33:121-32. (52) U.S. C. ...................................... 424/59; 514/177; M. Pathak, JAmer Acad Dermatol (1982) 7:285-312. 514/847; 514/886; 514/887; 514/938 P. Peters et al, Agents & Actions (1977) 7:545-53. 58) Field of Search........................... 424/59; 514/887 Primary Examiner-Dale R. Ore Attorney, Agent, or Firm-Irel & Manella 56) References Cited (57) ABSTRACT U.S. PATENT DOCUMENTS Mild dermal inflammation, such as mild eczema and 4,083,974 4/1978 Turi......................................