Here Comes the Sun — The Latest on Sunscreen Safety

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With all of the challenges to public health during the Summer of 2020, there is some comfort in the Centers for Disease Control’s (CDC) recommendation that fresh air and sunshine is beneficial. For decades, sunscreen has been marketed as an effective over-the-counter (OTC) product for the prevention of skin cancer, by far the most common of all cancers (ACS, 2020). The U.S. Food and Drug Administration (FDA) first called for safety and efficacy data for sunscreen products in 1972.[1] Ever since, the FDA has been trying to determine whether OTC sunscreen products are generally recognized as safe and effective. FDA’s conclusions will evolve as more data is gathered and technology for testing improves. The answers are important because consumers want safe and effective products.

On July 17, 2020, the Wall Street Journal published “Sunscreen Chemicals Accumulate in Body at High Levels.”[2] This article led with “For the second time in less than a year, a study of common sunscreen ingredients has established that the chemicals are absorbed into the bloodstream at concentrations far greater than the Food and Drug Administration’s safety threshold.” The tested ingredients (avobenzone, oxybenzone, octocrylene, ecamsule, homosalate, and octisalate) are commonly used in sunscreen products and were previously listed as approved active ingredients for OTC sunscreen products; however, the regulation listing these ingredients has been stayed indefinitely.[3]

The WSJ article referenced the FDA’s January 21, 2020 randomized clinical trial study “Effect of Sunscreen Application on Plasma Concentration of Sunscreen Active Ingredients” published in the Journal of the American Medical Association (JAMA).[4] The January 2020 article followed from a prior FDA randomized clinical trial reported in JAMA on May 6, 2019.[5] Both FDA studies examined the absorption of chemicals from sprays, lotions and creams used as sunscreens. The latter study had 48 instead of 24 subjects and tested 6 instead of 4 active ingredients.

In the May 2019 JAMA article, the FDA noted increased plasma concentrations but it concluded “[t]hese results do not indicate that individuals should refrain from the use of sunscreen.” In the January 2020 JAMA article, after more testing, the FDA again published that individuals had increased plasma concentrations of certain chemicals but again concluded “[t]hese findings do not indicate that individuals should refrain from the use of sunscreen.” The FDA on its website notes “[w]ithout further testing, the FDA does not know what levels of absorption can be considered safe.”[6] The FDA also notes “[t]he findings in these studies do not mean that the FDA has concluded that any of the ingredients tested are unsafe for use in sunscreens, nor does the FDA seeking further information indicate such.”

While the FDA seeks more research on ingredients, the Coronavirus Aid, Relief and Economic Security Act (CARES Act) has set a deadline for the FDA to issue a new proposed rule identifying which OTC sunscreen products are safe and effective. As part of the modernization of regulations for OTC drugs, Section 3854 of the CARES Act requires the Secretary of Health and Human Services to issue a revised proposed sunscreen order by September 2021 and then issue a final rule at least one year prior to the effective date of the revised order.[7] Until the time when a new rule is finalized, there are only two ingredients that the FDA already considers generally safe and effective based on the review of scientific evidence as explained in the prior proposed rule: zinc oxide and titanium dioxide.[8]

So for now, seeking shade, and wearing a hat, UV-protective clothing, and sunglasses will go a long way to making your socially-distanced outdoor adventures safe.

[1] 84 FR 6204 (III)(B)(1)

[2] https://www.wsj.com/articles/sunscreen-chemicals-accumulate-in-body-at-high-levels-11594978201#:~:text=There%20are%20two%20varieties%20of,if%20ever%2C%20used%20in%20sunscreens.

[3] See 21 CFR 352.

[4] JAMA. 2020;323(3):256–267

[5] “Effect of Sunscreen Application Under Maximal Use Conditions on Plasma Concentration of Sunscreen Active Ingredients,” JAMA. 2019;321(21):2082–2091

[6] https://www.fda.gov/news-events/fda-voices/shedding-more-light-sunscreen-absorption#:~:text=Without%20further%20testing%2C%20the%20FDA,absorption%20can%20be%20considered%20safe.

[7] CARES Act, Section 3854(c)(1) and (2)

[8] 84 FR 6204

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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