Derm Appeal Blog

It’s been available in other countries for years, but bemotrizinol has only recently been added to the FDA’s list of permitted sunscreen active ingredients, becoming the first new active ingredient approved for use in over-the-counter (OTC) sunscreen products in more than two decades. For the FDA, approving bemotrizinol represents an effort to advance sunscreen innovation by bringing a well-studied ingredient to the U.S. market for the first time in 20 years, although the compound has already undergone extensive use and evaluation abroad. For the dermatology industry in the U.S., the availability of bemotrizinol is a potential gamechanger, expanding the available options for effective, cosmetically acceptable photoprotection.

One-Two Punch

“People are more likely to use sun protection consistently when they can find products that meet their individual needs and preferences,” said Deborah S. Sarnoff, MD, President of The Skin Cancer Foundation, noting that skin cancer remains the most common cancer in the U.S. “Additional sunscreen options can help make daily sun protection more accessible and appeal to a broader range of consumers.”

Consumers will soon be able to purchase formulations that feature bemotrizinol under the brand name PARSOL Shield, adding another option to a comprehensive sun protection strategy that includes seeking shade, wearing protective clothing, hats, UV-blocking sunglasses, and using a broad-spectrum sunscreen with a minimum SPF of 30, or SPF 50 and above for prolonged outdoor exposure.

Because it is a chemical filter that protects against both UVA and UVB rays, bemotrizinol offers several advantages associated with modern sunscreen technology, providing broad-spectrum protection while maintaining favorable cosmetic properties. This combination delivers effective protection without the unpleasant thickness and unsightly white cast associated with mineral sunscreens. In addition, the larger molecular structure results in low levels of skin absorption.

It is also highly photostable, meaning it breaks down more slowly when exposed to sunlight and maintains its protective performance over time.

Benefits of Bemotrizinol

Broad-spectrum Protection: Shields skin from both UVA and UVB damage, helping reduce the risk of sunburn and long-term skin damage.

Photostability: Maintains nearly 98% effectiveness after extensive UV exposure, making it more reliable than other sunscreen agents.

Synergistic Effects: Combining bemotrizinol with other sunscreen agents, such as bisoctrizole or ethylhexyl triazone, can help enhance the overall SPF performance of a formulation.

Safety: Bemotrizinol has not shown estrogenic effects in vitro, making it a safe choice for regular use.

Huge Impact

According to cosmetic chemist Victoria Fu, co-founder of Chemist Confessions, the availability of bemotrizinol in the U.S. could “have a huge impact on the U.S. sunscreen industry.”

“As sunscreen formulators, we have felt the U.S. has been decades behind in sunscreen technology because of the limited sunscreen filters available to us,” she noted. “But with improved consumer education, there is now a bigger-than-ever demand for better sunscreen products.”

Meeting that demand could signal big changes for the dermatology and skincare industries, as manufacturers reformulate products to include bemotrizinol and clinicians start redirecting patients to new, improved sunscreen formulations.

According to Darrell Rigel, MD, MS, clinical professor at New York University, adjunct clinical professor at UT Southwestern, and consultant dermatologist at Cooper Clinic in Dallas, the approval of bemotrizinol may also represent a new regulatory pathway that could help bring additional options to U.S. consumers in the future.

While bemotrizinol represents a significant milestone, Dr. Rigel noted that additional sunscreen ingredients currently used in Europe and Japan may also offer potential benefits. Future approvals may usher in a new era of sunscreen innovation, expanding access to safe, effective, and user-friendly sun protection options.

Dr. Sarnoff welcomes continued innovation that can help prevent skin cancer and, ultimately, save lives.

“Increasing access to innovative sun protection tools,” she said, “is an important step toward improving sun-safe behaviors and reducing the burden of skin cancer in the United States.”

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