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The US FDA today added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant moment in the agency’s efforts to advance sunscreen innovation. Bemotrizinol is the first new active ingredient added to the over-the-counter (OTC) sunscreen monograph since 1999.

Bemotrizinol protects against both ultraviolet A and B rays and has low absorption through the skin into the body, according to the FDA announcement on June 9. The agency considers bemotrizinol generally recognized as safe and effective for sunscreen use by adults and children 6 months and older.

Medscape previously reported that, after approval, new formulations using bemotrizinol could be on the US market as soon as July 2026. Bemotrizinol has been used in Europe and other regions for years. 

‘A Genuinely Meaningful Advance’ 

The addition of bemotrizinol to the list of sunscreen active ingredients “is a genuinely meaningful advance and one that many of us in dermatology have been waiting decades to see,” Adam Friedman, MD, professor and chair of dermatology at GW School of Medicine and Health Sciences in Washington, DC, told Medscape Medical News. “While sunscreen innovation has continued globally, the United States has largely been limited to a stagnant pool of UV filters, creating a growing gap between what American consumers can access and what is available in many other countries.”

Friedman said one of the major unmet needs in sunscreen has been the ability to provide robust, photostable broad-spectrum protection while maintaining elegant cosmetic properties. “Many currently available US filters either have limitations in UVA coverage, require complex combinations to achieve broad-spectrum protection, or can make formulations heavier, greasier, or more difficult to wear daily,” he said.

Bemotrizinol is a highly photostable filter with broad absorption across both the UVB and UVA spectrum, he noted, “including UVA1 wavelengths that are particularly important for photoaging, pigmentary disorders, and cumulative photodamage. Because it is photostable, it can also help stabilize other sunscreen ingredients within formulations, potentially improving overall performance.”

The development is also important for patients, Friedman said, “because the best sunscreen is ultimately the one people are willing to use consistently.” Adding this formulation adds flexibility in developing products that are effective, cosmetically pleasing, and suitable for diverse skin tones, he noted.

‘A Milestone and a Starting Point’ 

Friedman said he views the announcement “as both a milestone and a starting point. The significance extends beyond a single ingredient,” he said. “It demonstrates that innovation within the US sunscreen marketplace is possible and may help pave the way for additional advances in photoprotection.”

The FDA finalized this action within seven months of issuing the proposed order, according to the agency’s announcement. 

One manufacturer, DSM Nutritional Products, has submitted an OTC monograph order request to add bemotrizinol (Parsol Shield), at concentrations up to 6%, as a new active ingredient in the OTC monograph for sunscreens. “ The FDA reviewed the request and proposed to amend the OTC monograph to add bemotrizinol as a sunscreen active ingredient,” the FDA stated in its announcement. 

In December 2025, the company announced that when bemotrizinol is approved, Parsol Shield will be available for use in sunscreen products “in accordance with the monograph conditions at that tim e.”

“An OTC monograph drug, such as a sunscreen product, can enter the market without an approved drug application if it meets certain requirements, including conditions established in its monograph such as permitted active ingredients, uses, and doses,” the FDA stated in its announcement, adding: “The FDA can modify an OTC monograph through an administrative order, and a drug company may start the process by submitting an OTC monograph order request.” 

Friedman is a consultant or adviser for: La Roche-Posay; Galderma; Kenvue; MicroCures; LEO Pharma; Pfizer; Hoth Therapeutics; Zylo Therapeutics; Mino Labs; Johnson & Johnson; Arcutis; Lilly; UCB; Novartis; Regeneron/Sanofi; and Takeda. He is a speaker or member of speakers bureau for: Regeneron/Sanofi; Johnson & Johnson; Incyte; UCB; Galderma; Arcutis; Lilly; Pfizer; Novartis Research funding from: Pfizer; Eli Lilly; Galderma; Incyte; Johnson & Johnson; AbbVie; Loreal; and Regeneron/Sanofi.
 

Marcia Frellick is a Chicago-based independent healthcare journalist and a regular contributor to Medscape.