Key facts
- The FDA approved bemotrizinol, the first new sunscreen ingredient in over 27 years.
- Bemotrizinol is a broad-spectrum chemical UV filter that has been available internationally since 2000.
- DSM-Firmenich will hold exclusive marketing rights for the ingredient for 18 months.
- Legislative efforts, including the CARES Act and the SAFE Sunscreen Standards Act, helped streamline the FDA's review process.
- Companies can start using bemotrizinol in products from August 9, 2026, with Kenvue confirming its use in Neutrogena products.
The U.S. Food and Drug Administration (FDA) has approved bemotrizinol, a new sunscreen ingredient, marking the first such approval in over two decades. This ingredient, sold internationally as PARSOL® Shield, has been available in Europe since 2000 and offers broad-spectrum protection against UVA and UVC radiation.
Bemotrizinol is a chemical UV filter that is noted for its stability and a more pleasing texture compared to other organic filters available in the U.S. Unlike some other filters, it is also recognized as Generally Recognized As Safe and Effective (GRASE) by the FDA, and it does not absorb into the skin as significantly as other organic filters.
The lengthy approval process in the U.S. was attributed to the FDA's historical lack of resources for reviewing new over-the-counter drug ingredients, despite legislative efforts like the Sunscreen Innovation Act. The CARES Act of 2020 and the subsequent SAFE Sunscreen Standards Act helped to create incentives and streamline the review process, leading to this approval.
DSM-Firmenich, the ingredient manufacturer, will have exclusive marketing rights for bemotrizinol for the first 18 months. Companies will be able to incorporate the ingredient into their products starting August 9, 2026. Kenvue, owner of brands like Neutrogena, has confirmed plans to integrate bemotrizinol into its future sunscreen innovations.