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3h ago

FDA Adds Bemotrizinol to U.S. Sunscreen Rules

The change could narrow a long-standing gap in UVA protection available to American consumers.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
The FDA approved bemotrizinol for U.S. sunscreens, marking the first new active ingredient allowed since the 1990s.
© Shutterstock / Amparo Garcia
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Overview

  • The FDA finalized a June 9 order adding bemotrizinol (BEMT) to the over-the-counter sunscreen monograph and designated it generally recognized as safe and effective for people aged 6 months and older.
  • The final rule allows bemotrizinol at concentrations up to 6 percent after the agency reviewed data on its broad-spectrum UVA/UVB protection, strong photostability, and low skin absorption.
  • Dutch manufacturer DSM (dsm-firmenich) will market the first U.S. product, Parsol Shield, and holds 18 months of exclusivity before other makers may use the ingredient.
  • Companies must reformulate and test products before retail launch, so consumer items with bemotrizinol are expected later in 2026 rather than immediately.
  • The approval is the first new sunscreen active in more than two decades and used the streamlined OTC monograph pathway created by the CARES Act, a step that could lead to more international filters reaching the U.S. market.