On Dec. 11, the U.S. Food and Drug Administration decided to review a submitted proposal for the ingredient bemotrizinol to be added to the list of permitted active ingredients for use in sunscreens.
This ingredient protects against ultraviolet A and B rays, has low levels of absorption into the body and rarely causes skin irritation; it is also already used in products in Europe and Australia. If the FDA determines it’s safe, bemotrizinol will be an additional sunscreen active ingredient that is safe for adults and children six months of age and older to use, according to a Dec. 11 announcement.
DSM Nutritional Products LLC, a manufacturer of vitamins and other nutritional ingredients used in food, feed, pharmaceuticals, personal care and dietary supplements submitted the request to the FDA. Their request sought approval of concentrations up to 6% of bemotrizinol.
The active ingredient is being reviewed within the OTC monograph for sunscreens. An over-the-counter (OTC) monograph drug—like sunscreen—can be marketed without a formal FDA-approved drug application as long as it follows the specific requirements in its monograph, including allowed ingredients, uses, and doses.
“The agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad. We’re continuing to modernize the regulation of sunscreen and other over-the-counter drug products,” said FDA Commissioner Marty Makary, MD. “Americans deserve timely access to the best safe, effective and consumer-friendly over-the-counter products available.”
