FDA Accepts Addition of Bemotrizinol as First New Sunscreen Ingredient in 20 Years

The FDA has approved bemotrizinol as a permitted active ingredient in over-the-counter (OTC) sunscreen products, according to an agency announcement on June 9, 2026.¹ The action marks the first addition to the OTC sunscreen monograph since the late 1990s and makes bemotrizinol the first new sunscreen active ingredient added through the streamlined administrative order process established by the CARES Act. The ingredient is approved for use in adults and children 6 months or older.¹

The FDA issued a proposed order on December 11, 2025, with a public comment period closing January 26, 2026.^1,2 DSM Nutritional Products, LLC, submitted the OTC monograph order request to add bemotrizinol at concentrations up to 6% as a new active ingredient, and the FDA finalized the action within 7 months of issuing the proposed order.¹

"This is exactly the kind of progress we can achieve when we modernize our processes and apply sound science to regulatory decisions," said Mike Davis, MD, PhD, acting director of the FDA’s Center for Drug Evaluation and Research (CDER), in the news release. “The FDA is committed to ensuring the American consumer has access to the most effective and safe therapies, including over-the-counter products like sunscreens.”¹

Bemotrizinol: UV Spectrum Coverage, Absorption Profile, and GRASE Determination

Bemotrizinol provides broad-spectrum protection against both UV-A and UV-B rays.¹ The ingredient has low levels of absorption through the skin into the body and rarely causes skin irritation, according to the FDA's review of available data.^1,2 Based on this review, the FDA considers bemotrizinol generally recognized as safe and effective (GRASE) for OTC sunscreen use.¹

“What makes bemotrizinol very interesting to add to the US armamentarium of sun protection is the fact that it is a broad spectrum chemical absorber. It is able to hit all of the UV-A and UV-B spectrum, protecting against aging, skin cancer, and sunburns. It's a larger molecule than some of our well-known chemical absorbers to date, such as avobenzone. This larger molecule of bemotrizinol doesn't penetrate the skin as easily, so you have less systemic absorption, potentially making it safer,” said Christopher Bunick, MD, PhD, associate professor of dermatology at Yale School of Medicine and Dermatology Times’ editor in chief.

The proposed order issued in December 2025 described bemotrizinol as an ingredient marketed in sunscreen products across Europe and numerous other countries for years prior to US regulatory action.² The FDA had not previously approved a drug application or added the ingredient to the sunscreen monograph before this action.² Concentrations up to 6% are permitted under the final order.¹

“This approval is a huge step for patients. The addition of this sunscreen filter allows US manufacturers to formulate in a cosmetically elegant way, and the products will begin to achieve the look and feel of all the European and Japanese sunscreens that have gone viral,” Kavita Mariwalla, MD, FAAD, a double board-certified dermatologist, Mohs surgeon, and current president of the American Society for Dermatologic Surgery, told Dermatology Times. “This filter gives expanded coverage for the UV spectrum, and that is a good thing. It gives us a chance to catch up to the science already in place in other parts of the world.”

Regulatory Pathway and OTC Monograph Process

Under the OTC monograph framework, a sunscreen product can enter the US market without an approved new drug application if it meets conditions set in the monograph, including permitted active ingredients, uses, and doses. The FDA can modify a monograph through an administrative order process, which a manufacturer initiates by submitting an OTC monograph order request. The CARES Act streamlined this process, enabling faster review cycles than prior regulatory pathways allowed.^1,2

“The FDA’s rigorous standards ensure consumers can be confident in the sunscreens and other nonprescription drugs they use,” said Karen Murry, MD, director of the Office of Nonprescription Drugs at the CDER, in the news release. “Now, through the best available science and updated regulatory framework, we can work with companies to get innovative products to market in a more efficient manner than ever before.”¹

In the December 2025 proposed order announcement, Murry described bemotrizinol as "a welcome addition to the current array of effective sunscreen active ingredients already available to American consumers."²

“Advances around sunscreen and skin cancer prevention are always welcome. Such progress helps our patients by expanding the options from which they can choose; that, by default, will increase adherence and use," Mona Gohara, MD, board-certified dermatologist and clinical professor of dermatology at Yale School of Medicine in New Haven, Connecticut, told Dermatology Times.

Dermatology clinicians may encounter patient and industry inquiries related to new sunscreen formulations containing bemotrizinol as manufacturers begin incorporating the ingredient. The ingredient's broad-spectrum coverage profile and low skin absorption may be relevant for patient counseling on sunscreen selection, particularly in populations where tolerability and efficacy across UV wavelengths are priorities.

“Sunscreen is about the art of formulation and mixing the filters to drive efficacy and a great aesthetic experience. This approval gives experts in formulation elevated ingredients to work with. At the end of the day, the best sunscreen is the one you will use, and the approval of this filter makes the options that much better for our patients,” Mariwalla concluded.

For an additional breakdown on bemotrizinol and what the ingredient's properties mean for sun protection and cosmetic elegance, watch below from Dermatology Times’ editor in chief, Christopher Bunick, MD, PhD.

References

1. FDA expands sunscreen options for the first time in 20 years. News release. FDA. June 9, 2026. Accessed June 9, 2026. https://www.fda.gov/news-events/press-announcements/fda-expands-sunscreen-options-first-time-20-years
2. FDA proposes expanding sunscreen active ingredient list. News release. FDA. December 11, 2025. Accessed June 9, 2026. https://www.fda.gov/news-events/press-announcements/fda-proposes-expanding-sunscreen-active-ingredient-list

Frequently Asked Questions

What is bemotrizinol, and how does it work in sunscreens?

Bemotrizinol is a broad-spectrum UV filter providing protection against both UV-A and -B rays. The FDA approved its addition to the over-the-counter (OTC) sunscreen monograph at concentrations up to 6% following a review showing low skin absorption and a low rate of skin irritation.

Is bemotrizinol safe for pediatric patients?

The FDA determined bemotrizinol to be generally recognized as safe and effective for use in adults and children 6 months or older, consistent with labeling standards for other approved OTC sunscreen active ingredients.

How is bemotrizinol added to the OTC monograph different from a standard drug approval?

OTC monograph products do not require an approved new drug application. Instead, manufacturers submit an OTC monograph order request and the FDA reviews it through the administrative order process established under the CARES Act. The final order amending the sunscreen monograph is what enables commercial marketing.