FDA Approves First New Sunscreen Ingredient in 27 Years, Promising Superior UVA Protection
The FDA has approved bemotrizinol, a highly photostable UV filter that has been used in Europe for decades, marking the first new over-the-counter sunscreen ingredient cleared for the U.S. market since 1999.
For the first time in 27 years, Americans will soon have a fundamentally new way to protect their skin from the sun. On June 9, 2026, the U.S. Food and Drug Administration officially approved bemotrizinol—often referred to as BEMT—as a safe and effective active ingredient for over-the-counter sunscreens.
The landmark decision ends a decades-long regulatory freeze that had left U.S. consumers relying on older, often flawed chemical filters, even as more advanced options became standard across Europe and Asia. The approval marks a significant shift in public health policy, offering a highly effective tool to combat rising rates of melanoma and other skin cancers.[1][8]
Bemotrizinol represents a major technological leap over the chemical filters currently dominating U.S. pharmacy shelves. It is a broad-spectrum organic filter, meaning it effectively absorbs both ultraviolet A (UVA) rays, which drive premature aging and skin cancer, and ultraviolet B (UVB) rays, which cause sunburns. Crucially, bemotrizinol is highly photostable.
Older chemical ingredients like avobenzone degrade rapidly when exposed to sunlight, losing their protective power exactly when it is needed most unless stabilized by other chemicals. Bemotrizinol maintains its structural integrity under direct UV exposure, providing consistent, long-lasting protection without breaking down into potentially irritating byproducts.[2][5]
For many consumers, the most immediate benefit of the new filter will be cosmetic. While mineral sunscreens containing zinc oxide or titanium dioxide offer excellent, stable broad-spectrum protection, they are notorious for leaving a chalky white cast on the skin. This heavy residue often discourages daily use, particularly among people of color.
Bemotrizinol, by contrast, goes on completely clear. By offering the robust protection of a mineral block with the invisible, lightweight finish of a chemical lotion, dermatologists expect the new ingredient to significantly boost the daily sunscreen compliance required to meaningfully reduce skin cancer risks.[4][6]
The safety profile of bemotrizinol also addresses long-standing concerns about chemical sunscreens. In recent years, studies have shown that older chemical filters, such as oxybenzone, can absorb through the skin and enter the bloodstream at levels far exceeding the FDA's threshold of concern. Bemotrizinol was specifically engineered as a large molecule.
Because of its size, it cannot easily cross the skin barrier, meaning it remains on the surface where it belongs. Rigorous testing confirmed minimal systemic absorption, leading the FDA to clear the ingredient for use by adults and children as young as six months old.[5][7]
The approval closes what consumer advocates have long called the "UVA gap" in American sun care. Bemotrizinol is not a new invention; it was developed by Swiss chemists in the 1990s and has been used safely in Europe, Asia, and Australia since 1999 under brand names like Tinosorb S. For decades, American dermatologists have watched with frustration as international consumers enjoyed access to superior sun protection while U.S. formulations stagnated.
Advocacy groups like the Environmental Working Group have spent years petitioning the federal government to modernize its approved list, arguing that the lack of photostable UVA filters constituted a genuine public health vulnerability.[4][5]
The 27-year delay stems from how the United States categorizes sun protection. Unlike Europe, which regulates sunscreens as cosmetics, the FDA classifies them as over-the-counter drugs. This designation requires pharmaceutical-grade clinical trials to prove safety and efficacy—a massive financial hurdle for manufacturers.
The original application for bemotrizinol was filed in 2005 but languished in a regulatory backlog. The breakthrough finally came via the CARES Act of 2020, which modernized the FDA's over-the-counter monograph system and allowed regulators to consider real-world safety data from decades of international use, rather than relying solely on new domestic clinical trials.[4][8]
While the approval is official, Americans will have to wait a few more months to purchase products containing the new filter. The first sunscreens formulated with bemotrizinol are expected to reach U.S. store shelves in the fall of 2026. Under the current regulatory framework, DSM Nutritional Products—which manufactures the ingredient under the trade name Parsol Shield—holds an 18-month exclusivity window. During this period, they will be the sole supplier, though several major skincare brands have already announced agreements to incorporate the filter into their upcoming product lines.[3][6]
For readers evaluating their sun protection strategy this summer, the advice remains practical: do not wait for the new formulations to start protecting your skin. Existing sunscreens, particularly mineral options containing zinc oxide, still provide excellent defense when applied generously and reapplied every two hours. However, the impending arrival of bemotrizinol means that the most common barriers to daily sunscreen use—greasiness, white cast, and concerns about chemical absorption—are about to be definitively solved.[5][7]
Where opinion splits
Dermatological Community
Medical professionals view the approval as a critical tool for reducing skin cancer rates.
Dermatologists and oncologists have long argued that the best sunscreen is simply the one a patient is willing to wear every day. By eliminating the chalky white cast of mineral blocks and the rapid degradation of older chemical filters, bemotrizinol removes the primary aesthetic and practical barriers to daily use. Medical experts anticipate that this cosmetically elegant option will significantly boost compliance, particularly among people of color who have historically struggled to find invisible broad-spectrum protection.
Consumer Safety Advocates
Watchdog groups celebrate the ingredient's safety profile and lack of systemic absorption.
Organizations like the Environmental Working Group have spent years highlighting the risks of older chemical filters like oxybenzone, which studies show can enter the bloodstream and potentially disrupt hormones. Advocates champion bemotrizinol because its large molecular structure prevents it from crossing the skin barrier. They view this approval as a monumental victory that finally closes the 'UVA gap' in the United States, providing a safe, non-toxic alternative to outdated chemical formulations.
Regulatory Officials
Regulators emphasize that the rigorous approval process ensures long-term public safety.
While acknowledging the frustration over the 27-year delay, FDA officials maintain that classifying sunscreens as over-the-counter drugs rather than cosmetics is necessary to protect American consumers. They point out that the modernized regulatory pathway established by the CARES Act of 2020 was the key to breaking the logjam. By allowing the agency to consider decades of real-world safety data from Europe and Asia, regulators were able to confidently clear the ingredient without compromising their strict safety standards.
Key points
- The FDA has approved bemotrizinol (BEMT), the first new over-the-counter sunscreen ingredient for the U.S. market since 1999.
- Bemotrizinol provides broad-spectrum protection against both UVA and UVB rays and does not degrade when exposed to sunlight.
- Because of its large molecular size, the ingredient sits on the skin's surface and is not absorbed into the bloodstream.
- Unlike mineral sunscreens, bemotrizinol goes on clear without leaving a white cast, making it suitable for all skin tones.
How we got here
1999
Bemotrizinol is first approved for use in sunscreens across Europe and Asia.
2005
The initial application for FDA approval of bemotrizinol is filed in the United States.
2020
The CARES Act is passed, modernizing the FDA's over-the-counter drug monograph system.
2024
DSM Nutritional Products submits a renewed request for bemotrizinol approval under the updated regulatory pathway.
June 2026
The FDA officially approves bemotrizinol as a safe and effective active ingredient for U.S. sunscreens.
Fall 2026
The first sunscreens formulated with bemotrizinol are expected to arrive on U.S. store shelves.
- Dermatological Community
- Medical professionals view the approval as a critical tool for reducing skin cancer rates.
- Consumer Safety Advocates
- Watchdog groups celebrate the ingredient's safety profile and lack of systemic absorption.
- Regulatory Officials
- Regulators emphasize that the rigorous approval process ensures long-term public safety.
Perspectives this story doesn't cover
- Sunscreen Manufacturers
- International Regulatory Bodies
Sources
[1]TIMERegulatory OfficialsFDA Approves the First New Sunscreen Ingredient in 20 Years. Here's What to Know.
Read on TIME →
[2]The ScientistConsumer Safety AdvocatesFDA Approves Bemotrizinol, the First New Sunscreen Ingredient in Decades
Read on The Scientist →
[3]Pharmacy TimesRegulatory OfficialsMeet the FDA's Newly Approved OTC Sunscreen Ingredient: Bemotrizinol
Read on Pharmacy Times →
[4]Environmental Working GroupConsumer Safety AdvocatesIn major win for U.S. consumers, FDA approves first new sunscreen ingredient in 25 years
Read on Environmental Working Group →
[5]Stanford MedicineDermatological CommunityA sunscreen 'gamechanger?' What the science says about bemotrizinol
Read on Stanford Medicine →
[6]HealthlineDermatological CommunityFDA Approves 'New' Sunscreen Ingredient Used in Europe and Asia for Years
Read on Healthline →
[7]MD Anderson Cancer CenterDermatological CommunityBemotrizinol: What to know about the new FDA-approved sunscreen ingredient
Read on MD Anderson Cancer Center →
[8]U.S. Food and Drug AdministrationRegulatory OfficialsFDA adds bemotrizinol to the list of permitted sunscreen active ingredients
Read on U.S. Food and Drug Administration →
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