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2d ago

FDA Proposes Adding Bemotrizinol to U.S. Sunscreens, Invites Public Comment

If finalized, the order would deem the UV filter GRASE at up to 6% under the OTC monograph, enabling launches without individual drug applications.

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Sunscreens in the U.S. could soon have a new ingredient that has been popular globally for years.

Overview

  • The agency posted a proposed order to amend OTC Monograph M020 to include bemotrizinol at concentrations up to 6% as a sunscreen active ingredient.
  • Public comments are open until Jan. 26, 2026 on Regulations.gov before the FDA decides whether to issue a final order.
  • FDA’s assessment cites broad UVA/UVB protection, strong photostability, low systemic absorption, and rare irritation, with use proposed for adults and children six months and older.
  • DSM Nutritional Products LLC submitted the request; under the monograph framework, compliant products could be marketed without an approved new drug application.
  • An FDA spokesperson said a final order is anticipated in summer or fall 2026, with potential U.S. availability in late 2026, which would be the first new sunscreen active in over two decades and a step welcomed by dermatology groups.