The U.S. Food and Drug Administration (FDA) has approved bemotrizinol (BEMT) as a new active ingredient for over-the-counter sunscreens, marking the first addition of a new UV filter to the U.S. sunscreen monograph in more than two decades.
Bemotrizinol is widely used in Europe and Asia and is valued for its broad-spectrum protection against both UVA and UVB rays, high photostability, and low skin absorption. It is expected to improve sunscreen performance by offering more stable and cosmetically elegant formulations compared with several existing U.S.-approved filters.
The ingredient has been deemed generally recognized as safe and effective (GRASE) for adults and children aged six months and older, following FDA review of safety and efficacy data.
The approval was granted under an expedited administrative process and allows use of bemotrizinol at concentrations of up to 6% in sunscreen formulations. It will be initially commercialized in the U.S. by DSM Nutritional Products under the brand name Parsol Shield, with early products expected to reach the market later in 2026.
Industry analysts view the decision as a significant modernization of U.S. sunscreen regulation, potentially narrowing the gap between American and international sun care standards.
