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FDA Adds Bemotrizinol to U.S. Sunscreen Ingredients

The agency certified a long‑used European UV filter as generally recognized as safe and effective for adults and children 6 months and older, clearing the way for U.S. product launches.

Overview

  • The FDA finalized approval of bemotrizinol on June 9, 2026, designating the chemical UV filter GRASE for use in over‑the‑counter sunscreens for adults and children 6 months and older.
  • The agency based its decision on evidence that bemotrizinol provides stable broad‑spectrum UVA and UVB protection at tested concentrations up to 6 percent and shows low measured skin absorption.
  • Approval used a streamlined OTC review pathway created by Congress in 2020, making bemotrizinol the first new active sunscreen ingredient added to the U.S. list in more than two decades.
  • Dutch company DSM (DSM‑Firmenich) will market the first U.S. product as Parsol Shield and holds an 18‑month exclusivity window, after which other manufacturers may incorporate the filter into formulations.
  • Experts and consumer groups say the decision narrows a long‑standing UVA protection gap in U.S. sunscreens and could spur lighter, longer‑lasting formulations, though consumers should not expect wide retail availability until manufacturers complete reformulation and launches later in 2026.