Overview
- The proposed order would allow bemotrizinol in OTC sunscreens at concentrations up to 6% under Monograph M020.
- The FDA says the filter provides broad-spectrum UVA/UVB protection, shows high photostability, has low systemic absorption, and rarely causes irritation.
- If finalized, bemotrizinol would be considered GRASE for adults and for children 6 months and older.
- DSM Nutritional Products submitted the petition; the ingredient is widely used internationally and marketed as PARSOL Shield.
- It would be the first new U.S. sunscreen active in more than 25 years, reflecting OTC monograph reforms under the CARES Act and the SAFE Sunscreen Standards Act, with products potentially reaching shelves in late 2026.