Our long national sunscreen nightmare is almost over

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The FDA has approved bemotrizinol, the first new chemical sunscreen filter since 1999, promising more effective and stable sunscreens in the US. This development could help counter anti-sunscreen misinformation and improve sun safety.

The U.S. Food and Drug Administration (FDA) has approved bemotrizinol, also known as Tinosorb S, as a new chemical sunscreen filter—the first such approval since 1999. This move is expected to lead to the availability of more effective and stable sunscreens in the United States, potentially transforming sun protection practices and addressing longstanding issues with American formulations.

For over two decades, American sunscreens have lagged behind international options, often characterized by white casts, sticky textures, and limited effectiveness. The recent FDA approval of bemotrizinol introduces a broad-spectrum, photostable chemical filter that offers better UVA and UVB protection. Unlike older filters, bemotrizinol is less likely to be absorbed into the bloodstream, addressing safety concerns raised in recent years. This approval follows the FDA’s 2019 and 2021 requests for more safety data on existing chemical filters, which had fueled anti-sunscreen sentiments and misinformation campaigns. The new filter, deemed GRASE (generally recognized as safe and effective), is expected to enable formulators to produce more effective, user-friendly sunscreens, potentially reducing the misinformation that has contributed to risky sun behaviors among youth. Experts emphasize that while mineral sunscreens remain safe, chemical options like bemotrizinol could bridge the gap in protection and formulation quality in the US market.

Implications for Sun Safety and Misinformation Combat

This approval could significantly improve sun protection in the US by enabling the development of more effective, stable, and cosmetically appealing sunscreens. It also provides a scientific counter to anti-sunscreen misinformation, which has gained traction on social media and contributed to risky behaviors such as tanning and reduced sunscreen use. Better formulations may encourage more consistent use, ultimately reducing skin cancer risk and long-term skin damage. Furthermore, this milestone signals a shift in FDA regulation, potentially paving the way for more innovative ingredients and enhanced public health outcomes.

Historical Challenges in US Sunscreen Regulations

For years, US consumers have faced limitations in sunscreen options, often settling for products with poor textures and limited UVA protection. International markets, especially in Asia and Europe, have long offered formulations that are more effective, lighter, and cosmetically appealing. The FDA’s regulatory stance has been cautious, primarily due to safety concerns about chemical filters, leading to a preference for mineral sunscreens like zinc oxide and titanium dioxide, which are deemed GRASE. The controversy intensified after studies showed some chemical filters were absorbed into the bloodstream, prompting the FDA to request more safety data in 2019 and 2021. This resulted in a temporary stagnation in new approvals, fueling anti-sunscreen sentiment and misinformation campaigns that falsely equate chemical filters with health risks. The recent approval of bemotrizinol marks a reversal, indicating progress in regulatory attitudes and scientific understanding.

“The approval of bemotrizinol represents a significant step forward in providing Americans with access to safer, more effective sunscreens.”

— Dr. Janet Woodcock, FDA Commissioner

Remaining Questions About Implementation and Impact

It is still unclear when and how quickly manufacturers will introduce products containing bemotrizinol in the US market. Details about regulatory pathways, formulation challenges, and consumer acceptance are still emerging. Additionally, the long-term safety and real-world effectiveness of bemotrizinol in diverse formulations remain to be fully studied and confirmed through post-market surveillance.

Next Steps for Market Adoption and Public Awareness

Manufacturers are expected to begin developing and submitting formulations using bemotrizinol for FDA approval and market release. Public health campaigns and dermatologists will likely promote its benefits to encourage wider adoption. Monitoring of product availability, safety, and consumer feedback will follow, shaping future regulations and innovation in sun protection products.

Key Questions

When will sunscreens with bemotrizinol be available in the US?

While the FDA has approved bemotrizinol, it may take several months to a year for manufacturers to develop, test, and bring products to market, depending on formulation and regulatory processes.

How does bemotrizinol compare to existing chemical filters?

Bemotrizinol offers broader UVA and UVB protection, is more photostable, and less likely to be absorbed into the bloodstream, making it a safer and more effective option.

Will mineral sunscreens still be necessary?

Mineral sunscreens remain safe and effective, especially for those with sensitive skin. The new chemical filter provides additional options, improving overall protection and formulation diversity.

Does this mean anti-sunscreen misinformation will decline?

The availability of better formulations may help counter misinformation by offering more effective and appealing products, but public education efforts will still be necessary to combat false claims.

Are there any safety concerns with bemotrizinol?

Bemotrizinol has been deemed GRASE by the FDA, indicating it is generally recognized as safe and effective based on current data. Ongoing studies will continue to monitor its safety in real-world use.

Source: The Verge