Health Law Daily Wrap Up, COSMETICS—FINAL RULES: FDA expands list of permitted sunscreen ingredients, (Jun 10, 2026)

By Donielle Tigay Stutland, J.D.

Bemotrizinol is the first new active ingredient to be added in over 20 years.

The FDA added bemotrizinol to the list of permitted sunscreen active ingredients, which is the first new active ingredient added to the over-the-counter (OTC) sunscreen monograph since the late 1990s. FDA’s action comes within seven months of its issuing the proposed order. The new ingredient has been marketed as a sunscreen ingredient in Europe and many countries around the world for years. The final order “Amending Over-the-counter Monograph M020: Sunscreen Drug Products for Over-theCounter Human Use, and Related Information” now states a sunscreen drug product containing bemotrizinol as a sunscreen active ingredient at concentrations up to 6 percent is generally recognized as safe and effective (GRASE) if it meets the conditions described in OTC Monograph M020 as amended by the final order (Final Rule, 91 Fed. Reg. 35220 (June 10, 2026)).

“As promised in the Trump Administration’s MAHA Strategy Report, HHS is advancing innovation by bringing a new sunscreen ingredient to the U.S. market for the first time in 20 years,” said HHS Secretary Robert F. Kennedy, Jr. “Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products.”

“This is exactly the kind of progress we can achieve when we modernize our processes and apply sound science to regulatory decisions,” said Mike Davis, M.D., Ph.D., Acting Director of the FDA Center for Drug Evaluation and Research (CDER). “The FDA is committed to ensuring the American consumer has access to the most effective and safe therapies, including over-the-counter products like sunscreens.”

On September 23, 2024, DSM Nutritional Products LLC submitted a Tier 1 OMOR requesting FDA issue an administrative order finding that a sunscreen drug product containing bemotrizinol as an active ingredient is GRASE under the conditions described in OTC Monograph M020. The FDA reviewed the request and proposed to amend the OTC monograph to add bemotrizinol as a sunscreen active ingredient. The agency issued a proposed order on December 12, 2025, to this effect, and the public could submit comments from December 12, 2025 - January 26, 2026.

The final order provides that for a sunscreen drug product containing bemotrizinol as a sunscreen active ingredient to be legally marketed without an approved application under section 505 of the FD&C Act (21 U.S.C. 355), among other requirements, it must conform to certain conditions that address the concentration of bemotrizinol in the sunscreen drug product, permitted combinations of bemotrizinol with other sunscreen active ingredients and with skin protectant active ingredients, and permitted dosage forms. The final order allows sunscreen drug products containing bemotrizinol to be in the following dosage forms: oil, lotion, cream, gel, butter, paste, ointment, stick, and spray.

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