The Food and Drug Administration announced it is considering allowing bemotrizinol to be used as an active ingredient in sunscreen sold in the United States.
Bemotrizinol, approved more than 20 years ago for use in the European Union, protects against both UVA and UVB rays and rarely causes skin irritation. The FDA said it may give the ingredient its “safe and effective” designation for adults and children ages 6 months and older.
The review follows passage of the CARES Act in March 2020, which created an expedited process for evaluating the safety and effectiveness of active ingredients in nonprescription sunscreens.
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Under the proposal, bemotrizinol could be used in sunscreen at concentrations of up to 6%.
“The agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad. We’re continuing to modernize the regulation of sunscreen and other over-the-counter drug products,” FDA Commissioner Marty Makary said. “Americans deserve timely access to the best safe, effective, and consumer-friendly over-the-counter products available.”
DSM Nutritional Products LLC, which petitioned the FDA for the rule change, submitted its proposal in 2024. The FDA has until early 2026 to review the application.
If approved, DSM’s sunscreen would be sold under the brand name PARSOL Shield.
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“PARSOL Shield has been safely used worldwide for over 20 years, and we are proud to lead the introduction of this proven technology to U.S. consumers. If approved, it will elevate the standard of sun protection and play a vital role in public health and skin cancer prevention,” said Parand Salmassinia, president of beauty and care at DSM-Firmenich.
