The U.S. Food and Drug Administration (FDA) has issued a proposed order that would add bemotrizinol to the list of permitted sunscreen active ingredients.

According to the FDA:
– bemotrizinol provides broad-spectrum UV protection and demonstrates low systemic absorption.
– Bemotrizinol has a low irritation potential
– if the proposed order is finalized, it would be considered generally recognized as safe and effective (GRASE) for use in adults and children over six months of age.
– it will be added to OTC Monograph M020, allowing its formal use in U.S. sunscreen formulations.

The petition submitted to FDA requested approval at concentrations of up to 6%.

The U.S. Department of Health and Human Services (HHS) expressed support for the proposal, highlighting the ingredient’s alignment with national health priorities: reduce sunburn, skin cancer risk, and premature skin aging when sunscreens are used as directed.

From a technical standpoint, bemotrizinol offers several advantages:
» Broad-spectrum coverage: It absorbs across nearly the entire UVB and UVA range, with strong peaks near 310 nm and 340 nm, providing meaningful protection against both burning (UVB) and UVA1-induced photoaging.
» Outstanding photostability: under very high experimental UV exposure, bemotrizinol shows minimal degradation.
» Stabilization of other filters: It enhances the stability of less photostable filters, such as avobenzone.
» Can help sunscreens maintain SPF and UVA protection closer to their labelled values during real-world use.