The Food and Drug Administration (FDA) has made a landmark decision that could revolutionize sun protection in the United States. On a recent Tuesday, the agency approved bemotrizinola novel sunscreen ingredient that has been widely used in Europe and other parts of the world for over two decades. This approval marks the first new sunscreen ingredient in the U.S. in more than 25 years, offering Americans access to advanced skin protection.
Bemotrizinol, also known as BEMThas been cleared for use in adults and children aged six months and older. The FDA’s rigorous evaluation confirmed that the ingredient meets the agency’s standards for protecting against dangerous ultraviolet rays while minimizing skin irritation and absorption. This approval is a significant step forward in public health and consumer protection.
Bemotrizinol: A Game-Changer in Sun Protection
The approval of bemotrizinol is expected to fill a critical gap in the U.S. sunscreen market. Unlike many current sunscreen ingredients, bemotrizinol offers broad-spectrum protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays. This dual protection is crucial because UVA rays penetrate deeply into the skin, contributing to premature aging and skin cancer, while UVB rays primarily cause sunburn.
One of the standout features of bemotrizinol is its ability to provide this comprehensive protection without leaving the white streaks associated with mineral-based sunscreens. This makes it an attractive option for consumers who have previously avoided mineral sunscreens due to their appearance. The ingredient is also highly photostablemeaning it does not break down in sunlight, unlike some other non-mineral filters currently available.
The Long Road to Approval
The journey to approve bemotrizinol in the U.S. has been a long and arduous one. The ingredient was first authorized in Europe in 1999 and has since been used safely in sunscreens across the continent and in Asia. However, the regulatory process in the U.S. has been notoriously slow, with the original application for FDA approval filed in 2005. It wasn’t until 2026 that the Dutch manufacturer DSM Nutritional Products submitted a new request under an updated regulatory process established by the CARES Act.
The FDA’s approval of bemotrizinol is the first to go through a streamlined process authorized by Congress in 2026. This new process aims to expedite the review of safe and effective nonprescription drug ingredients, including those used in sunscreens. The approval triggers an 18-month exclusivity period for DSM, which will initially sell bemotrizinol under the brand name Parsol Shield. After this period, other manufacturers will be able to incorporate the ingredient into their products.
The Broader Impact on Sunscreen Regulation
The approval of bemotrizinol is a significant victory for consumer advocacy groups like the Environmental Working Group (EWG)which has long pushed for improved sunscreen standards and the introduction of new ingredients. David Andrews, Ph.D., chief science officer at EWG, hailed the decision as a monumental step forward, stating that it will finally bring more effective and safer sun protection to American consumers.
However, the approval also highlights the need for further reforms in sunscreen regulation. Currently, U.S. sunscreen formulators have access to only 16 approved UV filters, compared to approximately 30 in Europe. The FDA has proposed meaningful reforms, including stronger UVA standards, SPF value limits, better labeling, and updated safety data requirements. Yet, none of these reforms have been finalized, leaving American consumers with fewer options than their counterparts in Europe and Asia.
Melanie Benesh, EWG’s vice president for government affairs, emphasized the need for Congress to step in and establish binding deadlines for chemical testing and real enforcement to pull non-compliant, unsafe products from the market. She also called on sunscreen manufacturers to provide the necessary safety data for other UV filters available internationally, ensuring that consumers have access to a wider range of options.
In the meantime, consumers can look forward to the introduction of bemotrizinol-containing sunscreens, which are expected to hit the market later this year. As the first new sunscreen ingredient in over two decades, bemotrizinol represents a significant advancement in sun protection, offering a stable, non-mineral option that provides strong, broad-spectrum protection against both UVA and UVB radiation.
