S051: Dilemmas in Skin Cancer Dilemmas Associated with Oxybenzone in Sunscreens

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1 S051: Dilemmas in Skin Cancer Dilemmas Associated with Oxybenzone in Sunscreens Henry W. Lim, MD Department of Dermatology Senior Vice President for Academic Affairs Henry Ford Hospital, Detroit, Michigan

2 Disclosure Investigator: Estée Lauder Ferndale Unigen Incyte Speaker, educational session: Pierre Fabre

3 Oxybenzone and Octinoxate (Schneider, S, Lim, HW. JAAD 2019 Jan;80(1):266. Detroit) Oxybenzone, 4-methylbenzylidenecamphor (not FDA approved), octocrylene, and octinoxate (ethylhexyl methoxycinnamate) are used in personal care products (cosmetic items, fragrances, flavors) and as photostabilizers plastics. Not easily removed by waste water treatment plan. Centers for Disease Control has estimated that up to 96.8% of the US population is exposed to oxybenzone.

4 Oxybenzone (Schneider, S, Lim, HW. JAAD 2019 Jan;80(1):266. Epub 2018 Nov 14.) Endocrinologic effects in rat model No known safety issues in humans (has been in us in the US since 1978)

5 Endocrine Effects of Sunscreens (Wang, SQ, Burnett, M, Lim, HW. Arch Dermatol, 2011; 147:865) Years of Daily Sunscreen Application to Achieve Oxybenzone Levels Given to Rats Scenario 1 Scenario 2 Scenario 3 BSA, % mg/cm Amt req d. 30 ml/d 15 ml/d 15 ml/d Time, yrs Assumption: Oxybenzone 10%; absorption: 2%. Body wt: 75 kg

6 Oxybenzone (Schneider, S, Lim, HW. JAAD 2019 Jan;80(1):266. Epub 2018 Nov 14) Endocrinologic effects in rat model No known safety issues in humans (has been in us in the US since 1978) Oxybenzone kills adult coral reefs, and deforms DNA in the larval stage (in laboratory settings) Detected in fish (low concentration)

7 Bleaching of Coral Reefs (National Oceanic and Atmospheric Administration. Great Barrier Reef Marine Park Authority 2016, Interim report: 2016 coral bleaching event on the Great Barrier Reef, GBRMPA, Townsville. New York Times, March 16, 2017) Along the Great Barrier Reef in Australia, bleaching of coral reefs occurred in remote areas with infrequent human contacts Warming of ocean water: major cause

8 Photoallergen Safety of Oxybenzone (Schneider, S, Lim, HW. JAAD 2019 Jan;80(1):266. Detroit) Endocrinologic effects and adverse effects on coral reefs: only in animal model and in laboratory settings, respectively Ocean warming is the major cause of coral reef bleaching Barkley, HC, et al. Commun Biol 2018; Nov 8; 1:177. Woods Hole, MA; Honolulu, Hawaii Cheng, L, et al. Science 2019, Jan 11; 363:128. Beijing, and Boulder, CO

9 Challenge The lack of other UVA filters, widely available and used in other parts of the world, limits the ability of manufacturers to remove oxybenzone from products marketed in the US

10 Regulations: Oxybenzone and Octinoxate Jan 2021: Ban in Hawaii and Key West, FL Legislation for 2019 to prohibit sale of sunscreens containing oxybenzone and octinoxate: introduced in California and Florida

11 Reef-safe sunscreens: Many contain non-nanotized ZnO

12 ZnO and TiO 2 (Corinaldesi, C, et al. Sci Total Environ 2018 Oct; ; ) Laboratory settings: Uncoated ZnO: rapid bleaching of coral (in sunscreens, ZnO particles are coated) TiO 2 : Did not cause bleaching

13 TiO 2 and ZnO Nanoparticles (Schneider, S, Lim, HW. Photodermatol Photoimmunol Photomed 2018 Nov 18. Epub) No evidence of clinically relevant percutaneous penetration; no side effects in human Not sufficient data on inflamed skin where epidermal barrier function has been compromised. Environmental adverse effets: very low

14 FDA Proposed Rule: Feb 26, 2019 (Federal Register.

15 FDA Proposed Rule: Feb 26, 2019 (Unpublished version released Feb. 21, 2019) Of the 16 UV filters listed in 1999 Final Monograph: 2 (zinc oxide and titanium dioxide): GRASE (= generally recognized as safe and effective) 2 (PABA, trolamine salicylate): Not GRASE 12: insufficient safety data to make a positive GRASE determination

16 What should we advise our patients? (Schneider, S, Lim, HW. JAAD 2019 Jan;80(1):266. Epub 2018 Nov 14) The adverse effects of sun exposure is well established. Practice of photoprotection is essential: Seek shade Wear photoprotective clothing, wide-brimmed hat, sunglasses Apply SPF>30 broad spectrum sunscreen to otherwise exposed area

17 What should we advise our patients? (Schneider, S, Lim, HW. JAAD 2019 Jan;80(1):266. Detroit) FDA proposed rule (2/26/19) is meant to seek more data, does NOT mean that current filters are unsafe For those concern about the environmental effect of oxybenzone or octinoxate: US: Use mineral (inorganic) sunscreen With practice of rigorous photoprotection: vit D IU daily

18 Detroit, MI Thank you!