The FDA has released a proposed administrative order that updates its over-the-counter (OTC) sunscreen monograph. The proposed order serves as a roadmap for manufacturers to bring OTC sunscreens to market and provides a pathway to finalize outstanding questions about safety and labeling of sunscreen ingredients.

The proposed order “is essentially a ‘rulebook’ for OTC sunscreen products in the future,” said Academy President Kenneth Tomecki, MD, FAAD, in a MedPage Today article. “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.”

The proposed order largely reflects what was outlined in the 2019 proposed rule on sunscreen. Highlights include:

  • Maximum labeled SPF value should be SPF 60+ while permitting the marketing of sunscreen products formulated with SPF values up to 80.
  • Sunscreens containing zinc oxide and titanium dioxide were deemed generally recognized as safe and effective (GRASE).
  • Aminobenzoic acid (PABA) and trolamine salicylate are not GRASE due to safety issues.
  • Cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone are not GRASE because more data is needed to make a GRASE determination.
  • All sunscreens with SPF values of 15 and above must satisfy broad spectrum requirements.
  • Updates proposed to sunscreen product labels, including an alphabetical listing of the active sunscreen ingredients in the product.
  • Sunscreen-insect repellent combinations are not GRASE due to inconsistencies in testing methods between FDA and the Environmental Protection Agency.

The FDA also issued a deemed final order, which outlines all existing FDA regulatory guidance on sunscreens, dating back to the final rule released in 1999 that was never implemented, and the 2011 labeling rules for sunscreens. This release was required by the Coronavirus Aid Relief and Economic Security Act and simply establishes what the current sunscreen requirements are. The proposed administrative order would modernize these established requirements with the latest science and research, and once finalized, will supersede these previous actions.

Academy advocacy

This proposed administrative order is not final, and the Academy, industry, and other stakeholders will have the opportunity to comment on the proposed guidance.

Resources for physicians and the public

The Academy has released a media statement and will develop talking points to assist members when answering questions from patients. The Academy will also develop educational resources to help the public navigate the implications of the FDA's proposed order.

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