FDA Issues Orders Clarifying Rules for Marketing Sunscreens

WASHINGTON — The FDA on Friday issued two orders officials say are aimed at making sunscreens safer and clarifying requirements regarding active ingredients, although for now there won’t be any noticeable effect on which sunscreen products consumers see on retail shelves.

“Americans can reduce risks from sun exposure with continued use of sun protection measures, including broad-spectrum sunscreen with SPF values of at least 15,” Acting FDA Commissioner Janet Woodcock, MD, said in a press release. “Today’s activities … will allow us to continue ensuring that sunscreens are safe and effective for frequent, life-long use and provide consumers with the protection they expect from these products.”

Friday’s “deemed final order” was an outgrowth of the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act, which “reformed and modernized the way sunscreens marketed without approved applications are regulated in the U.S.,” the agency said in the release. The order “sets the current requirements for marketing these OTC sunscreen products.”

OTC products like sunscreen don’t have to go through a rigorous approval process, because they’re in the category of being “generally recognized as safe and effective (GRASE),” the agency explained, noting that because the deemed final order basically preserves the way sunscreens are being marketed now, “the FDA believes that most sunscreens on the market are in compliance” with it.

In fact, consumers “will not see any changes from these actions for the most part,” Theresa Michele, MD, director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, told MedPage Today during a Friday afternoon phone call with reporters.

But problems with sunscreens remain, according to the Environmental Working Group (EWG), a nonprofit research and advocacy organization that focuses on agricultural subsidies, toxic chemicals, drinking water pollutants, and corporate accountability.

In a release, the group noted that a “proposed order” — an order the FDA also issued Friday, which will eventually replace the deemed final order — “says that sunscreen makers have failed to answer the FDA’s 2019 call to conduct studies on the health effects of sunscreens, including the extent chemicals in the products can enter the bloodstream. In fact, the FDA says two new studies on the absorption of sunscreen chemicals reinforce the need for the data the agency has sought for more than 2 years.”

“Sunscreen chemicals like oxybenzone pose significant health concerns, but the sunscreen industry continues to bury its head in the sand,” Scott Faber, EWG’s senior vice president for government affairs, said in the release. “We’re grateful the FDA continues to demand basic data on the health effects of these chemicals.”

In particular, in 2019, the FDA concluded that 12 active ingredients commonly found in sunscreens, including oxybenzone, need additional safety data. (The other ingredients are cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone and avobenzone, the group said.)

“Sunscreen sales have increased dramatically, so sunscreen companies can certainly afford to conduct the studies needed to ensure their customers are safe,” Faber said.

The proposed order includes a few differences from the deemed final order, the FDA said in a Q&A document about the two orders:

• Maximum SPFs: The deemed final order does not include a limit on maximum SPF values, while the proposed order proposes that the maximum labeled SPF value should be SPF 60+. However, the proposed order also permits the marketing of sunscreen products formulated with SPF values up to 80.

• Active ingredients: The deemed final order considers sunscreens containing 16 sunscreen active ingredients to be GRASE, consistent with an earlier sunscreen monograph posted in 1999. But based on new data and changed conditions since issuance of the 1999 monograph, the proposed order suggests GRASE status for sunscreens containing zinc oxide and titanium dioxide but not for sunscreens containing para-aminobenzoic acid (PABA) and trolamine salicylate, cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone.

• Dosage forms: The deemed final order does not address the GRASE status of sunscreens in specific dosage forms. By operation of a separate section of the CARES Act, sunscreens in dosage forms other than oils, lotions, creams, gels, butters, pastes, ointments, sticks, sprays, or powders require an approved application to be marketed. The proposed order proposes the following dosage forms as GRASE for use in sunscreens: oils, lotions, creams, gels, butters, pastes, ointments, and sticks. FDA proposes GRASE status for spray sunscreens, subject to testing and labeling requirements, and proposes that additional data are needed to determine that powders are GRASE.

• Sunscreen-insect repellent combinations: The deemed final order does not address sunscreen-insect repellent combinations, the agency noted. The proposed order proposes to classify these products as not GRASE because incompatibilities between FDA and EPA labeling requirements prevent these products from being labeled in a manner that sufficiently ensures safe and effective use of the sunscreen component and provides adequate directions for use.

The proposed order “is essentially a ‘rulebook’ for OTC sunscreen products in the future,” Kenneth Tomecki, MD, president of the American Academy of Dermatology, said in an email to MedPage Today. “It builds upon the labeling and testing requirements in the current ‘rulebook’ that sunscreen manufacturers will need to meet in the future. And this is a good thing! It means that the FDA is proactively taking steps to ensure the continued safety and efficacy of sunscreens and working to clarify confusion around sunscreen labels.”

In addition to those listed above, some of the other provisions of the proposed order include making “broad-spectrum” testing mandatory for all sunscreens with an SPF of 15 or higher, and requiring sunscreens in the form of sprays and powders to undergo additional testing and labeling requirements, Tomecki noted.

The FDA said it will consider comments on the proposed order — but not the deemed final order — submitted during a 45-day public comment period before issuing a revised final order.