The FDA Just Approved a New Sunscreen Ingredient— What It Means for Patients with Skin Cancer, Survivors, and the General Public

For anyone living with a history of skin cancer—or working to prevent it—sun protection shouldn’t be just a summer habit. That’s why today’s announcement from the U.S. Food and Drug Administration (FDA) is significant news for our community. 

For the first time in decades, the FDA has approved a new sunscreen active ingredient: bemotrizinol, also known as BEMT, or by its trade name Tinosorb S. This approval has the potential to meaningfully improve the quality and effectiveness of sun protection available to individuals in the United States. 

What Is Bemotrizinol? 

Bemotrizinol is a broad-spectrum UV filter (or active ingredient), meaning it blocks both UVA and UVB rays—the two types of ultraviolet radiation responsible for skin damage and increased melanoma risk. 

• UVB rays are the primary cause of sunburn and the main cause of melanoma, as well as basal cell and squamous cell skin cancers 

• UVA rays contribute to premature aging and increase oxidative stress, which indirectly causes mutations—increasing the risk of developing melanoma and other skin cancers 

Many sunscreen ingredients approved in the U.S. protect against one type of UV ray or the other, and most protect only against UVB. Bemotrizinol’s ability to effectively filter both makes it a particularly valuable addition to the sunscreen toolkit. 

The FDA has determined that bemotrizinol has low levels of absorption through the skin—a concern that has been raised in recent years about some existing sunscreen ingredients. The FDA has classified it as “generally recognized as safe and effective” (GRASE) for use by adults and children as young as 6 months old, at concentrations up to 6%. 

Why Has It Taken This Long? 

If you’ve purchased sunscreen abroad or from an international online store, you may have noticed that these products often contain ingredients not sold in the U.S. 

Europe, Canada, Australia, and many Asian countries have approved and used for decades numerous sunscreen filters that the U.S. has not approved, including bemotrizinol. Regulatory pathways for new over the counter (OTC) sunscreen ingredients in the U.S. are slow and complex, creating a gap between the protection available to consumers in the U.S. versus those in other parts of the world. To learn more about this topic, read our publication, The State of Sunscreen in the U.S..

Today’s approval is the first to move through a process established by the CARES Act, designed to modernize how the FDA evaluates over-the-counter drug ingredients. But there are still many other sunscreen filters used currently around the world that are awaiting FDA approval. We hope that more approvals are coming soon. 

Why Does This Matter for the Skin Cancer Community—and the General Public? 

UV exposure remains the single most preventable risk factor against skin cancer. Consistent and effective sunscreen use should be a cornerstone of ongoing skin cancer prevention for everyone. For melanoma survivors, people with a family history of the disease, and those with high-risk features such as fair skin, a large number of moles, or a history of significant sun exposure, protection from UV radiation is even more important.  

Here’s why this approval is meaningful for our community specifically: 

More effective formulations. Manufacturers can now develop sunscreens using bemotrizinol for the U.S. market, opening the door to products that offer broad-spectrum bemotrizinol alone or in combination with other filters, creating more effective sunscreen products for those living in the U.S. 

A more complete UVA shield. Current FDA-approved UVA filters have limitations. Bemotrizinol’s broad-spectrum coverage, particularly its strong UVA protection, addresses a real gap in what’s been available in the U.S. market. 

Improved cosmetic wearability. One barrier to consistent sunscreen use is texture and appearance. Access to newer filter technologies like bemotrizinol may support the development of lighter, more elegant formulas—sunscreens that may feel better on the skin. Sunscreens that feel better on the skin are more likely to be used.  

Greater consumer confidence. Knowing that a sunscreen active ingredient has been used safely in Europe for decades, reviewed by the FDA, and classified as safe and effective provides consumers with confidence. 

What’s Happening Now? 

Today’s approval doesn’t mean bemotrizinol-containing sunscreens are on shelves just yet—manufacturers will need time to formulate and bring new products to market. But here’s what we recommend in the meantime: 

• Continue using your current broad-spectrum SPF 30 or higher sunscreen daily—existing products remain effective and are your best line of defense right now 

• Reapply every two hours when outdoors, and immediately after swimming or sweating 

• Don’t rely on sunscreen alone—wearing protective clothing, wide-brimmed hats, and UV-blocking sunglasses, and seeking shade during peak UV hours (10am–4pm) remain critical 

• Talk to your dermatologist about your personal sun protection plan, especially if you are a melanoma survivor or have elevated risk factors 

• Perform regular skin self-exams and keep up with your scheduled dermatology appointments 

Looking Ahead 

Today’s FDA approval is a long-overdue first step forward for improved sun safety in the United States. For the skin cancer community, it represents both progress and promise—more options, better science, and the potential for improved protection for the people who need it most. 

At AIM at Melanoma/AIM at Skin Cancer, we will continue to monitor new sunscreen developments and update our community as bemotrizinol-containing products become available. Sunscreen is one of the most powerful tools we have for UV protection — and we are committed to making sure you have the best information possible to use it effectively. 

This blog post is for informational purposes only and does not constitute medical advice. Please consult your dermatologist or oncologist for personalized recommendations.