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FDA Proposes Expanding Active Ingredient List for Sunscreens
The FDA has announced a proposal to include bemitrizinol to its list of allowable active ingredients to include in sunscreens.
The US Food and Drug Administration (FDA) has announced a proposal to expand the current list of active sunscreen ingredients to include bemitrizinol.1
The December 11 announcement describes the FDA’s hope to modernize and expand sunscreen options as part of a larger initiative by the Office of Nonprescription Drugs. Agency officials have, as a result of this initiative, issued this new proposal to include bemotrizinol as an allowable active ingredient in formulations of sunscreen.
“The agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad,” FDA Commissioner Marty Makary, MD, MPH, said in a statement.1 “We’re continuing to modernize the regulation of sunscreen and other over-the-counter drug products.”
Makary further highlighted his belief in Americans’ timely access to the over-the-counter products, which are only the safest and most effective. Bemotrizinol provides users, according to data reviewed by FDA officials, with broad-spectrum protection against both UVA and UVB radiation.
In their announcement, the FDA also highlighted bemotrizinol’s minimal level of absorption through the skin into systemic circulation. They additionally noted the ingredient’s decreased likelihood of causing any skin irritation. Bemotrizinol would, if the proposal is finalized, become an additional active ingredient recognized by the agency as safe and effective for adults and for children aged 6 months and older.
Under existing regulations, an over-the-counter monograph drug—such as a sunscreen—may be marketed without a formal drug application as long as it adheres to the conditions outlined in its monograph, including permitted ingredients, intended uses, and dosing parameters. The FDA can revise a monograph through a proposed and then final administrative order. This process can be started by a company via an OTC Monograph Order Request (OMOR).
In this instance, DSM Nutritional Products LLC had given the agency an OMOR asking officials to allow bemotrizinol, in concentrations of up to 6 percent, to be added as a new active ingredient in the sunscreen monograph. While bemotrizinol is already being implemented in sunscreen products internationally, it has never been approved by the FDA in a drug application nor previously included in the US’s sunscreen monograph.
“Bemotrizinol would be a welcome addition to the current array of effective sunscreen active ingredients already available to American consumers,” Karen Murry, MD, acting director of the FDA’s Office of Nonprescription Drugs, said in a statement.1 “The reforms to the monograph drug system contained in the CARES Act have greatly streamlined the monograph drug regulatory process, and 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.”
FDA officials will continue to regulate sunscreen ingredients to ensure established standards for safety and effectiveness are met. Given the noted benefits of broad-spectrum sunscreens with an SPF of 15 or higher on public health and skin cancer, the agency advises the public to incorporate sunscreen into daily sun-safety practices.
The FDA announcement also highlighted the agency’s current acceptance of public comments on the proposed administrative order. Details on ways to submit any related feedback can be found in the proposed order posted on OTC Monographs@FDA. In this release, the FDA also noted its ultimate decision on bemotrizinol meeting the necessary criteria to be considered generally safe will be issued in a final order, adding the ingredient to OTC Monograph M020.1
References
FDA Proposes Expanding Sunscreen Active Ingredient List. US Food and Drug Administration. December 11, 2025. https://www.fda.gov/news-events/press-announcements/fda-proposes-expanding-sunscreen-active-ingredient-list?utm_medium=email&utm_source=govdelivery.
Viale PH. Protecting Against Sun Exposure: Which SPF Will You Recommend? J Adv Pract Oncol. 2017 Mar;8(2):134-135. doi: 10.6004/jadpro.2017.8.2.1. Epub 2017 Mar 1. PMID: 29900021; PMCID: PMC5995491.
