Lim, Henry W

Mohammad, Tasneem F

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Henry Ford Health System Henry Ford Health System Scholarly Commons Dermatology Articles Dermatology 3-24-2021 The Important Role of Dermatologists in Public Education on Sunscreens Tasneem F. Mohammad Henry W. Lim Follow this and additional works at: https://scholarlycommons.henryford.com/dermatology_articles The Important Role of Dermatologists in Public Education on SunscreensTasneem F. Mohammad, MD; Henry W. Lim, MDThe Sunscreen Innovation Act was enacted on November26, 2014, to help expedite the approval process for UVfilters by the US Food and Drug Administration (FDA),given that no new filters had been approved in severalyears. Nearly 5 years later,on February 26, 2019, theFDA released a proposedrule (84 FR 6204)1,2 in response to the Sunscreen InnovationAct that addressed the classification and labeling of over-the-counter sunscreen products. A component of this FDAproposal is to classify the 16 sunscreen active ingredients (ie,UV filters) listed in the 1999 FDA final monograph into 3 cat-egories: category I, generally recognized as safe and effective(GRASE); category II, not GRASE; and category III, insuffi-cient safety data to support a positive GRASE determination.Currently, sunscreen manufacturers are working with theFDA to discuss safety data needed for 8 of the 12 activeingredients listed in category III.Another component of the FDA proposal is to require sun-screen active ingredients to be placed on the principal dis-play panel of the label to facilitate product comparison.1,2 Theprincipal display panel is defined by the FDA as the portion ofthe label that is most evident when the product is displayedfor retail sale. It should be noted that although changes to sun-screen labeling have been proposed, little is known regardinghow consumers evaluate and prioritize sunscreen ingredi-ents in their decision-making and selection of sunscreen prod-ucts. Therefore, evidence is greatly needed to identify keypoints for dermatologists to better educate patients regard-ing sunscreen as a part of photoprotection.In this issue of JAMA Dermatology, Tribby and colleagues3evaluate how the proposed revisions may affect labeling.The authors explore the usefulness of listing the active ingre-dients on the principal display panel and the ability of studyparticipants to recall these ingredients when selecting sun-screen products. Study participants were shown 2 mock la-bels, 1 meeting the current FDA guideline and 1 aiming to meetthe proposed FDA guideline. Participants were queried on therecall of ingredients and how the ingredients influenced theirsunscreen selection. The study found that fewer than 30% ofstudy participants used information on the active ingredi-ents as the primary factor in choosing sunscreen and thatonly 11% could recall any of the active ingredients after view-ing both labels.Only 1 of the 47 participants in the study by Tribby andcolleagues looked at the label to seek environmentally safeingredients.3 The main reason for environmental concern isthe association found between the active ingredients in sun-screen and coral reef bleaching, with oxybenzone being themost widely discussed UV filter.4,5 In laboratory settings, theconcentration of UV filters required to decrease chlorophyllcontent and overall coral cell growth is 1000-fold higher thanthat measured in ocean water. Also, it is not clear what rela-tive contribution sunscreen-derived oxybenzone makes tomarine environments, which may be detrimentally affectedby industrial sources of oxybenzone as well as by globalwarming.On January 1, 2021, Hawaii banned the sale of sunscreenproducts containing octinoxate and oxybenzone. On January21, 2021, the state’s legislature introduced new bills that pro-pose also banning sunscreens containing avobenzone, homo-salate, octisalate, and octocrylene.6 However, because of therelatively small number of FDA-approved UV filters, their re-moval from the US market is not easily accomplished. Thereare limited options for achieving a final sunscreen product witha high sun protection factor (SPF) and broad-spectrum cover-age. Approval of other broad-spectrum photostable filters bythe FDA would be most beneficial to achieving this goal. Con-sidering the varying degrees of environmental awareness andconcerns in different geographic areas, if the study by Tribbyand colleagues3 had been conducted in an area other thanWashington, DC, a higher percentage of participants mighthave tried to avoid ingredients with perceived environmen-tal consequences.Five of the 47 participants in the study by Tribby andcolleagues3 avoided certain ingredients for personal health rea-sons. A systematic review of 29 studies7 was recently pub-lished on the association of octinoxate and oxybenzone withhuman health. For oxybenzone, no adverse effects were ob-served for male or female fertility, female reproductive hor-mone levels, adiposity, fetal growth, child neurodevelop-ment, or sexual maturation. While associations with thyroidhormone, testosterone level, kidney function, and pubertaltiming were reported, causal relationships were not estab-lished. No reported effect of octinoxate on thyroid or repro-ductive hormone levels was noted. The authors concluded thatcurrent evidence is not sufficient to support the causal rela-tionship between an elevated systemic level of octinoxate oroxybenzone and adverse health outcomes.In a study by Matta and colleagues,8 scientists at the FDAshowed systemic absorption of 6 organic sunscreen filters whenapplied to 75% of the body at a concentration of 2 mg per cm2(the concentration used in SPF testing). Notably, absorptionwas detected even after a single application. This finding wasused to support the need for additional safety testing on sun-screen filters; however, the authors clearly stated that their re-sults did not indicate that individuals should refrain from usingsunscreen.Related articleOpinionEDITORIALjamadermatology.com (Reprinted) JAMA Dermatology Published online March 24, 2021 E1© 2021 American Medical Association. All rights reserved.Downloaded From: https://jamanetwork.com/ by a Henry Ford Health System User  on 04/20/2021As discussed by Tribby and colleagues,3 a previous studyby Xu and colleagues9 showed that cosmetic elegance is themost-cited positive feature of highly rated sunscreens. Thisstudy focused on sun-sensitive individuals who typically havefair skin and may apply products containing inorganic filters(ie, titanium dioxide and zinc oxide) to maintain a cosmeti-cally preferred appearance. In consumers with richly pig-mented skin, sunscreen is used primarily to prevent photoag-ing and pigmentary problems. This subgroup may favor organic(also known as chemical) sunscreen filters because inorganicfilters can be cosmetically unacceptable—leaving a white filmon the skin. Further studies are needed on sunscreens and in-dividuals with richly pigmented skin.In the US, active ingredients in sunscreens are regulatedby the FDA as over-the-counter drugs. On March 27, 2020,the Coronavirus Aid, Relief, and Economic Security (CARES)Act10 was signed into law. Under the CARES Act, the FDA isto update and finalize requirements for over-the-counterdrugs, including sunscreens, via a streamlined administra-tive order process intended to improve efficiency, timeli-ness, and predictability. As a result, a final sunscreen orderwill no longer undergo a time-consuming 3-phase process tobe incorporated into the final sunscreen monograph11;instead, it will automatically be deemed a final administra-tive order and be effective immediately. Consequently, theCARES Act will replace the Sunscreen Innovation Act onSeptember 30, 2022.Under the CARES Act,10 the FDA is required to issue a pro-posed administrative order by September 27, 2021. Once thefinal administrative order has been issued, sunscreen manu-facturers will have at least 1 year to ensure that products of-fered on the shelves in the US are in compliance. The CARESAct also incentivizes innovation by providing an opportunityfor an 18-month exclusivity period to the requesting manu-facturer of a new filter. This exclusivity period begins on thedate when the manufacturer can lawfully market the sun-screen ingredient. Notably, none of these provisions changethe safety testing that the FDA is requiring for category III sun-screen ingredients listed in the 1999 proposed rule.1,2The study by Tribby and colleagues3 confirms what mostclinicians have suspected from interacting with patients—that the general public may not have enough information onthe key factors that should influence decision-making regard-ing sunscreen selection. While most consumers look for SPFvalues, and some might look for broad-spectrum labeling,this study points to an opportunity for dermatologists to edu-cate patients on the key factors to consider when choosing asunscreen.Dermatologists are in the best position to educate the pub-lic on the importance of photoprotection for skin health, in-cluding seeking shade when outdoors; wearing photoprotec-tive clothing, a wide-brimmed hat, and sunglasses; andapplying broad-spectrum sunscreen with an SPF 30 or higher.Given the evolving information on sunscreen safety, the en-vironmental consequences of sunscreen, and new sunscreenregulations, dermatologists are in a unique position to edu-cate the public on the proper practice of photoprotection andto provide objective and updated information on sunscreens.ARTICLE INFORMATIONAuthor Affiliations: Department of Dermatology,Henry Ford Health System, Detroit, Michigan.Corresponding Author: Henry W. Lim, MD,Department of Dermatology, Henry Ford HealthSystem, 3031 W Grand Blvd, Ste 800, Detroit, MI48202 (hlim1@hfhs.org).Published Online: March 24, 2021.doi:10.1001/jamadermatol.2020.5393Conflict of Interest Disclosures: Dr Mohammadreported being a subinvestigator for Allergan andFerndale, with grants paid by Allergan and Ferndaleto his institution, outside the submitted work.Dr Lim reported grants to his institution fromIncyte, L’Oréal, Pfizer, and PCORI; consulting feesfrom Beiersdorf, Ferndale, ISDIN, La Roche-Posay,and Pierre Fabre; and speaking engagements withCantabria Labs and La Roche-Posay, all outside thesubmitted work.REFERENCES1. Wang SQ, Lim HW. Highlights and implications ofthe 2019 proposed rule on sunscreens by the USFood and Drug Administration. J Am Acad Dermatol.2019;81(2):650-651. doi:10.1016/j.jaad.2019.04.0072. US Department of Health and Human Services,Food and Drug Administration. Sunscreen drugproducts for over-the-counter human use.Proposed rule 84 FR 6204. Federal Register.February 26, 2019. Accessed January 31, 2021.https://www.federalregister.gov/documents/2019/02/26/2019-03019/sunscreen-drug-products-for-over-the-counter-human-use3. Tribby CP, Julian AK, Perna FM. Perceivedusefulness and recall of sunscreen label informationby consumers. JAMA Dermatol. Published onlineMarch 24, 2021. doi:10.1001/jamadermatol.2020.53944. Downs CA, Kramarsky-Winter E, Segal R, et al.Toxicopathological effects of the sunscreen UV filter,oxybenzone (benzophenone-3), on coral planulaeand cultured primary cells and its environmentalcontamination in Hawaii and the U.S. Virgin Islands.Arch Environ Contam Toxicol. 2016;70(2):265-288.doi:10.1007/s00244-015-0227-75. Mitchelmore CL, He K, Gonsior M, et al.Occurrence and distribution of UV-filters and otheranthropogenic contaminants in coastal surfacewater, sediment, and coral tissue from Hawaii. SciTotal Environ. 2019;670:398-410. doi:10.1016/j.scitotenv.2019.03.0346. An Act Relating to Water Pollution, HB 1860§342D-21, 30th Leg (Hawaii 2021). AccessedFebruary 9, 2021. https://www.capitol.hawaii.gov/session2020/bills/HB1860_.HTM7. Suh S, Pham C, Smith J, Mesinkovska NA. Thebanned sunscreen ingredients and their impact onhuman health: a systematic review. Int J Dermatol.2020;59(9):1033-1042. doi:10.1111/ijd.148248. Matta MK, Florian J, Zusterzeel R, et al. Effect ofsunscreen application on plasma concentration ofsunscreen active ingredients: a randomized clinicaltrial. JAMA. 2020;323(3):256-267. doi:10.1001/jama.2019.207479. Xu S, Kwa M, Agarwal A, Rademaker A, KunduRV. Sunscreen product performance and otherdeterminants of consumer preferences. JAMADermatol. 2016;152(8):920-927. doi:10.1001/jamadermatol.2016.234410. Coronavirus Aid, Relief, and Economic SecurityAct. 15 USC §116 (2020). Accessed January 31, 2021.https://uscode.house.gov/view.xhtml?path=&req=Coronavirus&f=treesort&fq=true&num=23&hl=true&edition=prelim11. Evans A. Examining the monograph.Dermatology World Weekly. November 2020.Accessed January 29, 2021. https://www.aad.org/dw/monthly/2020/november/feature-examining-monographOpinion EditorialE2 JAMA Dermatology Published online March 24, 2021 (Reprinted) jamadermatology.com© 2021 American Medical Association. All rights reserved.Downloaded From: https://jamanetwork.com/ by a Henry Ford Health System User  on 04/20/2021

The Important Role of Dermatologists in Public Education on Sunscreens

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The Important Role of Dermatologists in Public Education on Sunscreens

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