FDA Approves Bemotrizinol as an OTC Sunscreen Ingredient

The FDA officially expanded the nation’s sunscreen options for the first time in over 2 decades. On June 9, 2026, the agency added the active ingredient bemotrizinol to the OTC sunscreen monograph, marking a significant shift in the regulatory landscape and offering a new tool for pharmacists to recommend in the fight against skin cancer.¹

This decision, finalized just 7 months after the initial proposal, represents the first new sunscreen ingredient permitted in the United States since the late 1990s.

For pharmacists on the front lines of patient counseling, this approval addresses a long-standing gap between domestic sun care and international standards. Although the United States classifies sunscreen filters as OTC drugs requiring rigorous clinical trials, many other countries treat them as cosmetics, allowing for faster adoption of new technologies. Consequently, bemotrizinol has been used safely across Europe, Australia, and Asia for decades, and American consumers are limited to older chemical filters or mineral-based options like zinc oxide and titanium dioxide.^1-3

This advancement was a priority of the Make America Healthy Again strategy, aimed at modernizing regulatory processes that had previously fallen behind other nations, according to Health and Human Services Secretary Robert F. Kennedy Jr. The approval was made possible through the streamlined administrative order process established by the CARES Act, allowing the FDA to modify the OTC monograph more efficiently when supported by sound science. Under the final order, manufacturers are now permitted to include bemotrizinol in sunscreen formulations at concentrations up to 6%.¹

“As promised in the Trump administration’s MAHA Strategy Report, HHS is advancing innovation by bringing a new sunscreen ingredient to the U.S. market for the first time in 20 years,” Kennedy said in the news release.¹ “Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products.”

From a clinical perspective, bemotrizinol offers several distinct advantages that pharmacists can highlight to patients who are dissatisfied with current products. As a highly effective, oil-soluble organic chemical UV filter, it provides broad-spectrum protection by absorbing both UVA and UVB rays.²

Unlike traditional mineral sunscreens that often leave a chalky white residue—a common complaint among those with deeper skin tones—bemotrizinol formulations can be designed to dry without leaving a visible cast. Furthermore, it is notably photostable, meaning it does not break down quickly under sunlight and can even enhance the durability of other filters within a product.²

FDA Acting Director Mike Davis and other officials have emphasized that bemotrizinol is generally recognized as safe and effective for adults and children aged 6 months and older. Because bemotrizinol molecules are larger than those of some older chemical filters, the ingredient has shown low levels of absorption through the skin into the body. This profile may make it a preferable alternative for patients with sensitive skin who may experience irritation from other chemical ingredients like octinoxate or octisalate.^1,2

Despite the excitement surrounding this new ingredient, pharmacists should continue to reinforce fundamental sun safety principles with their patients. The Skin Cancer Foundation stresses that no sunscreen is "waterproof," and even "water-resistant" formulas require reapplication every 2 hours, or immediately after swimming or sweating. Patients should be advised to apply a shot glass amount—roughly 1 ounce—to cover the entire body 15 to 30 minutes before sun exposure.^3,4

Additionally, pharmacists can play a crucial role in managing sunscreen inventory and patient education regarding shelf life. FDA regulations require products to remain stable for at least 3 years, and any product without an explicit expiration date should be considered expired 3 years after purchase.³

As the new bemotrizinol-enhanced products reach retail shelves, ensuring that patients understand how to store these containers—keeping them out of direct heat and sun to maintain efficacy—will be vital for maximizing the public health benefits of this regulatory milestone.³

“The FDA’s rigorous standards ensure consumers can be confident in the sunscreens and other nonprescription drugs they use,” Karen Murry, MD, director of the office of nonprescription drugs in the Center for Drug Evaluation and Research, said 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.”

READ MORE: Dermatology Resource Center

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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. Forefront Dermatology. Bemotrizinol: what does this new sunscreen ingredient mean for the US?. Accessed June 9, 2026. https://forefrontdermatology.com/bemotrizinol-sunscreen-ingredient/

3. FDA. Sunscreen: how to help protect your skin from the sun. June 9, 2026. Accessed June 9, 2026. https://www.fda.gov/drugs/understanding-over-counter-medicines/sunscreen-how-help-protect-your-skin-sun

4. Skin Cancer Foundation. Sunscreen & your skin. Accessed June 9, 2026. https://www.skincancer.org/skin-cancer-prevention/sun-protection/sunscreen/