FDA Rolls Out Proposal Rule for Final Monograph on Sunscreen Use

Close up on woman applying sun cream on her arm with a spray at the beach on a warm, sunny day. Sunscreen protection, skin cancer concept
The proposal includes the generally recognized as safe and effective (GRASE) status of 16 approved UV filters, dosage forms, and SPF recommendations.

In early 2019, the US Food and Drug Administration (FDA) issued a proposal to put into effect an official document on the use of nonprescription sunscreens. The proposal also includes the generally recognized as safe and effective (GRASE) status of 16 approved UV filters, dosage forms, and SPF recommendations. Highlights from the proposal were published in a paper in the Journal of the American Academy of Dermatology.

The proposed rule, initiated on February 26, 2019, will include a final monograph regarding over-the-counter sunscreen. Public comments on the proposal will be accepted by the FDA until May 28, 2019, representing a 90-day period from the rule’s announcement. During this period, dermatologists are urged to communicate the proposal to patients in an effort to increase awareness of the importance of sunscreen use for preventing skin cancer and reducing the visible signs of aging. The public is encouraged to comment in writing to the FDA if they wish to participate in the rule-making process.

In the proposal, the rule will categorize 16 UV filters currently listed in the US FDA 1999 Final Monograph into 3 GRASE status categories. Category 1 (GRASE) includes the primary broad-spectrum mineral sunscreen ingredients, zinc oxide and titanium dioxide. The second category, Not GRASE, includes 2 UV filters no longer available in the United States: para-aminobenzoic acid and trolamine salicylate. Category 3 includes filters which have insufficient safety to determine a positive GRASE status. The 12 remaining filters are undergoing or will undergo additional safety testing by the FDA, but the agency commented that it is unconcerned regarding the filters’ safety and efficacy.

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Dosage formulations considered GRASE in the proposal include oils, lotions, butters, gels, pastes, ointments, and sticks. Spray sunscreens and sunscreen powders, however, require further study.

The proposal will also raise the maximum value of SPF sunscreen manufacturers can claim on their product, from 50+ to 60+. Sunscreens claiming broad-spectrum protection must meet a UVA I (340-400 nm)/UV (290-400 nm) ratio of ≥0.7.

“For those concerned about the environmental impact of UV filters, sunscreens containing titanium dioxide and/or zinc oxide can be used,” the authors of the proposal highlight wrote in their paper. “It is also important that we continue to educate the public that sunscreens are safe and effective.”

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Wang SQ, Lim HW. Highlights and implications of the 2019 proposed rule on sunscreens by the US Food and Drug Administration [published online April 4, 2019]. J Am Acad Dermatol. doi:10.1016/j.jaad.2019.04.007