FDA Opens U.S. Sunscreen Rules to Bemotrizinol

The U.S. Food and Drug Administration approved the first new sunscreen ingredient to be permitted for over-the-counter consumer use in the U.S. since 1999.

1. Frame 1FDA approved bemotrizinol for a federal sunscreen rule, adding a skin-safety filter after nearly three decades.
2. Frame 2The filter now checks two hazards: it filters UVA and UVB, with low skin absorption, according to FDA.
3. Frame 3UVA can damage skin beyond sunburn because UVB is only part of the ultraviolet hazard.
4. Frame 4The rule changes the OTC monograph, a document that lets compliant products skip separate drug applications.
5. Frame 5DSM requested up to 6 percent; FDA review moved from proposed order to public comments to final order.
6. Frame 6Failure mode stays practical: labels must match permitted ingredients, uses, and doses before shoppers benefit.