FDA has published a proposed administrative order to include bemotrizinol (BEMT) as an active ingredient in over-the-counter (OTC) sunscreen products under the U.S. sunscreen monograph. The list has remained largely unchanged for decades, making this development a significant shift that may open the door for U.S. consumers to access more modern sun-protection technologies already used internationally.
What exactly has FDA proposed, and what would change if the proposal is finalized?
If finalized, the order would allow sunscreen manufacturers to use BEMT at concentrations of up to 6% and would classify the ingredient as generally recognized as safe and effective (GRASE) for broad-spectrum sunscreens intended for adults and children six months old and older. BEMT would be added to OTC Monograph M020, enabling sunscreen manufacturers to market products using BEMT without submitting individual New Drug Applications. Products incorporating BEMT could reach the market as early as late 2026, depending on when FDA issues a final order.
What is BEMT and how is it different?
BEMT is an oil-soluble organic UV filter with a high molecular weight that offers protection against both UVA and UVB rays. BEMT works through a different mechanism than mineral filters like zinc oxide and titanium dioxide, which are inorganic ingredients that mostly absorb and scatter UV rays. As a result, its addition to the monograph would expand the range of formulations available to U.S. sunscreen manufacturers.
How did we get here and how long did it take?
For many years, the list of approved sunscreen ingredients in the United States saw little change, even as newer UV filters were being adopted in Europe and Asia. In response to this growing gap, Congress passed the Sunscreen Innovation Act (SIA) in 2014, designed to accelerate FDA review and approval of new sunscreen active ingredients. But the slow pace of notice and comment rulemaking and scientific hurdles meant no new ingredients were added. The Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 replaced the rulemaking process with a faster administrative order framework, without lowering scientific standards. Through this new process, BEMT was assessed under FDA’s rigorous GRASE standards.
What comes next?
Under the CARES Act administrative order framework, FDA reviews data submitted in an OTC Monograph Order Request (OMOR), issues a proposed order, considers public comments, and may then finalize the order. BEMT’s pathway illustrates the modern requirements applied to all new sunscreen active ingredients: FDA now expects comprehensive safety and effectiveness data to support a GRASE determination. Any new active ingredient—including BEMT—must therefore provide a robust data package addressing these updated standards. FDA has indicated a final order could be issued in mid- to late 2026, with products potentially reaching the market thereafter. Whether additional UV filters follow depends on whether sponsors are willing to invest in meeting FDA’s contemporary data expectations.
Please call us if you have any questions about FDA’s proposed order, or have questions about your sunscreen products.