Bemotrizinol Moves Closer to US FDA Approval

The limitations imposed on sunscreen manufacturers in the US are well-documented. In comparison to Europe and Asia, the US market has the fewest approved sunscreen actives. Currently, only nine ingredients are commonly used for formulating marketable US sunscreen products. Further, it’s been 25 years since the last UV filter, Ensulizole, was added to the US Food and Drug Administration’s Sunscreen Monograph. But a new approval is on the horizon.

DSM-Firmenich’s Bemotrizinol (BEMT) sunscreen active has been under FDA review for over 19 years. It has been globally approved for more than 20 years in other countries. Now, BEMT may soon be available in the US. In an interview with HBW Insight, Carl D’Ruiz, head, NA Personal Care and Pharma Regulatory and Scientific Affairs, DSM-Firmenich, said if the approval process continues as expected, FDA will approve BEMT’s use as an OTC UV filter late next year or early 2026. Once, the approval comes, products featuring BEMT will soon be available in the US, according to D’Ruiz.

BEMT is a photostable broad-spectrum filter that efficiently provides UVA and UVB protection even at low concentrations, according to DSM-Firmenich. It is easy to use and compatible with both organic and inorganic UV filters. 

In a LinkedIn post, D’Ruiz said: “BEMT has garnered trust among consumers worldwide.  Now, as we stand on the cusp of realization, after nearly two decades of unwavering dedication, we glimpse the finish line with a sense of triumph and anticipation.”

DSM-Firmenich has spent about $20 million to get the BEMT approved during the past two decades. A sunscreen’s arduous journey has been documented in Happi.