FDA approves bemotrizinol, first new U.S. sunscreen active in more than 20 years
The FDA has approved bemotrizinol as a new over-the-counter sunscreen active, the first U.S. addition in more than 20 years, cleared at up to 6% for adults and children and expected to appear in U.S. products beginning in 2026.
Key takeaways
- New active: Bemotrizinol (BEMT) was added to the OTC sunscreen monograph and declared GRASE at up to 6%. Source: FDA press announcement.
- First filer: DSM Nutritional Products (DSM‑Firmenich) submitted the OMOR and will market bemotrizinol as Parsol Shield, receiving ~18 months limited exclusivity. Source: FDA press announcement.
- Performance: Bemotrizinol is a broad‑spectrum, photostable UVA/UVB filter that can stabilize other filters in formulations. Source: dermatology review.
- Public health impact: The approval tests the OMOR pathway created by CARES Act reforms and could accelerate modernization of U.S. sunscreen options.
Main content
A milestone for U.S. sunscreen regulation
The FDA’s final administrative order added bemotrizinol to the OTC sunscreen monograph (M020), declaring the ingredient Generally Recognized as Safe and Effective (GRASE) for use in sunscreens at concentrations up to 6%. This is the first new sunscreen active added to the U.S. monograph in over two decades and represents a practical test of the new OTC Monograph Order Request (OMOR) pathway established under CARES Act reform. For details, see the FDA press announcement and the FDA’s monograph Q&A on the OMOR process: FDA Q&A.
What bemotrizinol is and how it performs
Bemotrizinol, INCI bis‑ethylhexyloxyphenol methoxyphenyl triazine (BEMT), is a chemical UV filter widely used outside the U.S. It absorbs both UVA and UVB rays and is notably photostable, helping maintain protection under sunlight and stabilizing other UV filters in a formula. Dermatology reviews characterize bemotrizinol among advanced filters that provide broader, more stable protection than some older U.S. filters. Source: dermatology review.
Safety profile and absorption data
The FDA’s GRASE finding drew on safety, efficacy, and pharmacokinetic data submitted by the filer. Clinical pharmacokinetic studies cited by regulators showed plasma concentrations rarely exceeded 0.5 ng/mL, a benchmark used in recent sunscreen absorption research. Adverse events in trials were few and mostly mild; the FDA concluded bemotrizinol has low dermal absorption and an acceptable irritancy profile at concentrations up to 6%. Peer‑reviewed literature documents long overseas use and generally supports safety. Sources: FDA press announcement; dermatology review.
Monograph conditions and product forms
Under the monograph, bemotrizinol may be used at up to 6%, combined with other permitted sunscreen actives, and formulated in multiple dosage forms — lotions, creams, gels, sticks and sprays. The FDA also specified manufacturing precautions for sprays to limit inhalation and flammability risks. These conditions mirror broader monograph safety measures. For regulatory analysis and details, see the industry review and FDA documentation: industry commentary; FDA documentation.
Industry and agency reactions
FDA Commissioner Marty Makary, MD, MPH, acknowledged the agency’s past delays in updating sunscreen rules and framed the bemotrizinol approval as corrective. As he stated,
“We’re continuing to modernize the regulation of sunscreen and other over‑the‑counter drug products… Americans deserve timely access to the best safe, effective and consumer‑friendly over‑the‑counter products available.”
Acting director Karen Murry, MD, called bemotrizinol “a welcome addition” and signaled the agency’s intent to work with companies to bring other new actives to market more quickly. Source: FDA press announcement.
What this means for consumers and manufacturers
Consumers stand to gain more choice and potentially improved UVA protection — important for reducing skin cancer risk and photoaging — because bemotrizinol’s photostability helps maintain protection during sun exposure. Formulators can target stronger protection with lighter textures, which may increase user compliance. For manufacturers, the approval validates the OMOR pathway and may encourage additional filings for modern filters. After DSM’s estimated 18‑month limited exclusivity, other brands may incorporate bemotrizinol under monograph rules. Sources: FDA press announcement; industry commentary.
Regulatory background: why it mattered
Historically, the U.S. lagged behind Europe and Asia because the 1999 monograph did not include many modern photostable filters. The CARES Act reforms introduced the OMOR process to allow evidence‑based updates to OTC monographs. Bemotrizinol is the first sunscreen active to clear that path, creating a precedent that could close regulatory gaps with other regions. Sources: FDA press announcement; dermatology review.
Implications for The World
- Global harmonization: The U.S. move narrows the gap with regions that have used bemotrizinol for years, easing global formula alignment. Source: dermatology review.
- Public health: Broader access to advanced, photostable filters could improve population sun protection if products reach consumers and are used correctly. Source: dermatology review.
- Market effects: Global sunscreen makers may accelerate U.S. launches once exclusivity ends, increasing competition and possibly lowering prices. Source: FDA press announcement; industry commentary.
- Regulatory precedent: The OMOR pathway’s use here sets a model for future updates to U.S. sunscreen regulation. Source: FDA Q&A.
- Consumer guidance: Public health agencies continue to recommend broad‑spectrum sunscreens (SPF 15+; many experts recommend SPF 30+), reapplication every two hours, protective clothing and shade — bemotrizinol expands the toolkit but does not replace these measures. Sources: FDA press announcement; dermatology review.
Conclusion
Bemotrizinol’s addition to the U.S. OTC sunscreen monograph is a notable regulatory and public‑health milestone: it expands available filters, validates the OMOR pathway, and may catalyze broader modernization of sunscreen options in the U.S. and beyond.
