FDA Approves Bemotrizinol, First New Sunscreen Ingredient in Nearly 20 Years
On June 9, 2026, the U.S. Food and Drug Administration (FDA) approved bemotrizinol (BEMT), a new active ingredient for use in over-the-counter sunscreens. This marks the first addition to the FDA's list of permitted sunscreen filters in nearly 20 years, ending a long drought that has frustrated dermatologists and consumer advocates alike.
Bemotrizinol is a chemical UV filter that has been widely used in Europe, Australia, and Asia for more than two decades. The FDA's final order allows the ingredient to be used at concentrations up to 6% in sunscreen products, and it is considered generally recognized as safe and effective (GRASE) for adults and children aged six months and older.
A Long-Awaited Approval
The approval process began when DSM Nutritional Products LLC submitted an over-the-counter monograph order request. The FDA issued a proposed order on December 12, 2025, opened a public comment period through January 26, 2026, and finalized the decision within seven months. Manufacturers are expected to incorporate BEMT into their product lines quickly, possibly before the end of summer 2026.
"This is a great day for American consumers and everyone who has fought to improve sunscreen options and close the UVA protection gap in U.S. sunscreens," said David Andrews, PhD, chief science officer at the Environmental Working Group (EWG), in a statement following the approval.
Why Bemotrizinol Matters: Broad-Spectrum Protection and Better Feel
Bemotrizinol offers several advantages over the older sunscreen filters currently available in the United States. The sun emits two types of harmful ultraviolet radiation: UVB rays, which cause sunburn and contribute to skin cancer, and UVA rays, which penetrate deeper and cause wrinkles, age spots, and also contribute to cancer. Most effective sunscreens protect against both—known as broad-spectrum protection.
Superior Stability and Coverage
Currently, most chemical filters available in the U.S. protect against either UVA or UVB, but not both. Products typically require a mix of ingredients to achieve broad-spectrum coverage. BEMT is unique because it is a broad-spectrum filter on its own, filtering an even longer range of radiation than most current ingredients, according to Saranya Wyles, a dermatology researcher at the Mayo Clinic.
Additionally, many existing chemical sunscreens break down quickly in sunlight, requiring frequent reapplication. Bemotrizinol is far more stable, meaning it doesn't degrade as easily and offers longer-lasting protection.
A More Pleasant User Experience
American sunscreens have long been criticized for their unpleasant texture—greasy, chalky, or ghostly white residue. This is a major reason why only about 13% of American adults apply sunscreen daily, despite its known benefits for preventing skin cancer and premature aging. BEMT is expected to provide a more cosmetically elegant feel, which could encourage more consistent use.
Kathleen Suozzi, a dermatologic surgeon at the Yale School of Medicine, said, "It's quite overdue to come to the U.S. market, because it has important advantages over our current sunscreens."
Addressing Safety Concerns: Low Absorption Into the Body
One of the key concerns driving regulatory caution around new sunscreen ingredients has been the potential for chemical filters to be absorbed into the bloodstream. In 2020, a study found that certain sunscreen ingredients appeared in the bloodstream at levels higher than the FDA recommends. While no evidence has linked those blood levels to harm, the finding spurred further scrutiny.
Bemotrizinol has been shown to have low levels of absorption through the skin into the body, according to the FDA. This characteristic may help alleviate some consumer anxiety about using chemical sunscreens. The FDA's GRASE designation confirms that the ingredient is safe and effective for its intended use.
The Long Road to Approval: A Gap in U.S. Sunscreen Innovation
The approval of bemotrizinol ends a decades-long dry spell for new sunscreen filters in the United States. While other countries—notably those in Europe, Australia, and Asia—have regularly updated their sunscreen ingredient lists with advanced filters like bemotrizinol, the U.S. has lagged behind due to a more stringent regulatory process.
Regulatory Hurdles
Under U.S. law, sunscreen ingredients are regulated as over-the-counter drugs, which means they must go through a more rigorous approval process than in many other countries where they are treated as cosmetics. The last new sunscreen ingredient approved by the FDA was in the late 1990s, leaving American consumers with outdated technology while the rest of the world moved forward.
This regulatory gap has been a source of frustration for dermatologists, consumer advocacy groups like the EWG, and the public. For years, Americans seeking better sun protection often imported sunscreens from Europe or Asia, or relied on mineral sunscreens (zinc oxide and titanium dioxide) that offer broad-spectrum protection but often leave a white cast.
A Win for Advocacy
The approval of BEMT is seen as a victory for groups that have long pushed for expanded sunscreen options. Department of Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement, "Bemotrizinol has been used safely in Europe for decades, and FDA's action will increase competition and consumer confidence in sunscreen products."
Implications for Public Health and the Sunscreen Market
The arrival of bemotrizinol is expected to reshape the U.S. sunscreen market and could have significant public health implications. Skin cancer is the most common cancer in the United States, and regular sunscreen use is a key preventive measure. Yet many people avoid sunscreen because of its unpleasant feel or concerns about safety.
Potential for Increased Usage
Dermatologists hope that the improved texture and stability of BEMT-based sunscreens will encourage more people to apply sunscreen daily. The fact that BEMT is less likely to sting or irritate sensitive skin is another potential benefit, especially for children and people with conditions like eczema.
"The approval of bemotrizinol will help change that. The FDA's go-ahead will finally bring more effective, safer sun protection to American store shelves," said the EWG's David Andrews.
A Boost for U.S. Sunscreen Manufacturers
For American sunscreen manufacturers, the approval opens the door to new product formulations that can compete with global brands. Many international sunscreen products already contain bemotrizinol, and U.S. companies have been eager to incorporate it into their lines. The ability to market a sunscreen that is both highly effective and cosmetically elegant could drive sales and brand loyalty.
The Bigger Picture: Skin Cancer Prevention and Evolving Standards
The approval of bemotrizinol is part of a broader trend toward modernizing sunscreen regulations and improving public health outcomes. The FDA has signaled that it is open to reviewing additional new sunscreen ingredients, and other advanced filters currently used abroad—such as Tinosorb S and Tinosorb M—may also be considered for approval in the future.
Closing the UVA Protection Gap
One of the critical issues that BEMT addresses is the UVA protection gap. Many U.S. sunscreens have historically offered strong UVB protection (measured by SPF) but weaker UVA protection. The FDA's proposed rule on sunscreen labeling, issued in 2019 and not yet finalized, would require sunscreens with an SPF of 15 or higher to also provide adequate UVA protection to be labeled "broad spectrum." Bemotrizinol's strong UVA filtering capability will help manufacturers meet these anticipated standards.
Impact on Young Adults: A Link to Rising Colon Cancer Rates?
While sunscreen is primarily associated with preventing skin cancer, broader public health trends show that other cancers are rising among young adults. A recent report highlighted the colon cancer crisis, with ultra-processed foods linked to an increase in cases among younger populations. Although not directly related to sunscreen, the trend underscores the importance of preventive health measures across all age groups.
What Consumers Can Expect Next
Consumers can expect to see products containing bemotrizinol on store shelves within months. The FDA's order allows its use at concentrations up to 6%, and manufacturers are already working on new formulations. These sunscreens will likely be marketed as offering superior UVA protection, longer-lasting wear, and a more pleasant feel.
Guidance for Consumers
Dermatologists recommend that consumers continue to use broad-spectrum sunscreen with an SPF of 30 or higher, and that they apply it generously and reapply every two hours or after swimming or sweating. The addition of BEMT does not eliminate the need for these practices, but it does give Americans access to a more effective and user-friendly option.
For those who prefer mineral sunscreens, zinc oxide and titanium dioxide remain excellent choices. But for those who have avoided chemical sunscreens due to texture or absorption concerns, bemotrizinol-based products may offer a welcome alternative.
Conclusion: A New Era for American Sunscreens
The FDA's approval of bemotrizinol represents a significant milestone in the effort to improve sun protection in the United States. After nearly 20 years without a new sunscreen ingredient, American consumers will finally have access to a filter that has been trusted globally for decades.
While the regulatory process has been slow, the outcome is a clear win for public health. With better protection, improved stability, and a more pleasant user experience, bemotrizinol has the potential to increase daily sunscreen use and reduce the burden of skin cancer.
As the summer of 2026 approaches, the arrival of bemotrizinol-based sunscreens could not be more timely. For dermatologists, advocates, and the millions of Americans who care about skin health, this is a development worth celebrating.
For more on health and wellness, read our coverage of Simone Biles' recent health scare.
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