A milestone was reached today that could finally bring U.S. consumers access to the type of modern, more effective sun protection used abroad for decades: The Food and Drug Administration is proposing classifying bemotrizinol as an active ingredient in over-the-counter sunscreens.

Happi reported on this big move last week, as seen here.

The move is part of the agency’s renewed effort to modernize the outdated sunscreen marketplace and encourage innovation.

Personal Care Products Council Statement

 “The Personal Care Products Council (PCPC) applauds the U.S. Food and Drug Administration’s (FDA) proposal to add bemotrizinol (BEMT) to the over-the-counter (OTC) sunscreen monograph as Generally Recognized as Safe and Effective (GRASE). This regulatory milestone marks the first new UV filter approved as GRASE in the United States in more than 20 years, a significant advancement for the cosmetics and personal care products industry and consumers.

“Bemotrizinol offers broad-spectrum UVA and UVB protection and has a strong global safety record. Its inclusion helps bring U.S. sunscreen innovation closer to international standards, ensuring consumers have access to the most effective sun protection technologies.

“While this milestone is significant, PCPC continues to advocate for an accelerated pathway for additional modern UV filters. Streamlining regulatory approvals is essential to keep pace with scientific advancements and meet growing consumer demand for safe, effective sun care.

“We commend FDA for taking this important step and look forward to collaborating on future initiatives to modernize U.S. sunscreen regulation and strengthen skin cancer prevention.”

EWG Looks at Sunscreens

EWG has documented the shortcomings of many sunscreens sold in the U.S. The organization has also long urged the adoption of modern ingredients used widely in Europe and elsewhere that offer better, more reliable protection against the risks of sun exposure.

“This proposal signals real hope for public health,” said David Andrews, Ph.D., EWG’s acting chief science officer. “Mineral sunscreens are a top choice for consumers, but for those who prefer non-mineral products the ingredient options have been limited. “For years, Americans have been denied access to sunscreen ingredients that offer stronger UVA protection with fewer health concerns.

“Approving bemotrizinol would finally begin to close the gap between U.S. consumers and the rest of the world,” he added.

American Academy of Dermatology

The American Academy of Dermatology Association is also on board.

The following is a statement from Susan C. Taylor, MD, FAAD, president, American Academy of Dermatology (AAD):

“AAD applauds the Food and Drug Administration for taking the first steps in more than two decades to provide more safe and effective sunscreen options to the American public. The agency announced today that they are proposing to add a new sunscreen ingredient to protect the public’s health.

“U”nprotected exposure to UV rays is a major risk factor for skin cancer, the most common cancer in the United States. It is estimated that one in five Americans will develop skin cancer in their lifetime and nearly 20 Americans die from melanoma, the deadliest form of skin cancer, every day.

“Because dermatologists see first-hand the impact that skin cancer has on patients and their families, they recommend everyone apply sunscreen, seek shade, and wear protective clothing to protect their skin from sunburn, early skin aging, and skin cancer. The Academy recommends that everyone use a broad-spectrum, water-resistant sunscreen with an SPF of 30 or higher on skin not protected by clothing when outside.

“The Academy has been advocating for many years for the availability of more sunscreen options for US. consumers. The United States lags behind many other countries that have nearly twice as many approved sunscreen ingredients.

“The Academy remains committed to supporting and enhancing patient care. If you have questions about skin cancer and sun protection, partner with a board-certified dermatologist.”

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