FDA Proposes New Sunscreen Ingredient, Bemotrizinol, too Boost Consumer Choice
The U.S. Food and Drug Administration is taking steps to modernize sunscreen regulations, proposing the addition of bemotrizinol as a new active ingredient permitted for use in over-the-counter sunscreens. This move, announced on December 11, 2025, aims to expand consumer options and align U.S.standards with those of many other countries.
The FDA’s review of available data indicates that bemotrizinol offers robust protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays, exhibits minimal absorption into the body through the skin, and is unlikely to cause skin irritation. If finalized, the addition would classify bemotrizinol as generally recognized as safe and effective for use in adults and children aged six months and older.
“The agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad,” stated FDA Commissioner Marty Makary, M.D., M.P.H. “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-amiable over-the-counter products available.”
Streamlining OTC Drug Approvals
The process for introducing new sunscreen ingredients is governed by regulations surrounding over-the-counter (OTC) monograph drugs. Thes products can be marketed without pre-approval, provided they adhere to specific requirements outlined in the monograph, including permitted ingredients, usage guidelines, and dosage levels. The FDA can modify these monographs through administrative orders, often initiated by companies submitting an OTC Monograph Order request (OMOR).
DSM Nutritional Products LLC initiated this latest advancement by requesting the FDA add bemotrizinol – at concentrations up to 6 percent – to the sunscreen monograph. While already approved for use in numerous countries, bemotrizinol has not previously been authorized by the FDA for inclusion in U.S. sunscreen products.
Public Health Benefits and Ongoing Regulation
The FDA emphasizes its commitment to ensuring the safety and efficacy of sunscreens. Broad spectrum sunscreens with an SPF of 15 or higher are crucial in preventing sunburn and reducing the risks of skin cancer and premature skin aging, particularly when used in conjunction with other protective measures like protective clothing and limiting sun exposure.
“Bemotrizinol would be a welcome addition to the current array of effective sunscreen active ingredients already available to American consumers,” said Karen Murry,M.D., acting Director of the Office of Nonprescription Drugs. she also highlighted the impact of reforms contained within the CARES Act, which have significantly streamlined the OTC drug regulatory process. “We look forward to working with other companies on bringing products containing other new active ingredients to market for a wide array of conditions in multiple therapeutic areas,in a much more timely fashion than was possible in the past.”
The FDA is currently soliciting public comments on the proposed order, with instructions for submission available on the OTC Monographs @ FDA portal. Should the agency determine bemotrizinol to be safe and effective, a final order will be issued, adding the ingredient to OTC Monograph M020.
For additional information regarding OTC monograph drugs and the administrative order process, visit the OTC Monographs @ FDA portal. Further details about sunscreens can be found on the FDA’s consumer page dedicated to the topic.
The FDA, an agency within the U.S. Department of Health and Human services, is dedicated to protecting public health by ensuring the safety, effectiveness, and security of a wide range of products, including human and veterinary drugs, vaccines, medical devices, the nation’s food supply, cosmetics, and dietary supplements.
