Amid push to modernize OTC standards in the U.S., the FDA has proposed on Thursday, December 11, to add bemotrizinol [1] as a permitted active ingredient for use in sunscreen products. This broad-spectrum UV filter is widely used worldwide to protect against both UVB and UVA rays.
In its announcement, the FDA said bemotrizinol provides has low levels of absorption through the skin into the body, and rarely causes skin irritation.
Historic move
If this action is finalized, bemotrizinol will provide an additional option for formulators seeking to create effective sunscreen products for use in the USA.
The addition of a new substance to the list of generally recognized as safe and effective (GRASE) active ingredients enables OTC products containing it to be marketed more easily. Indeed, once an OTC product meets all applicable FDA requirements — including those related to active ingredients and their concentrations — it can enter the market without an approved drug application.
“The agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad,” said FDA Commissioner Marty Makary.
The American Academy of Dermatology Association, long an advocate for expanding sunscreen options for U.S. consumers, has applauded the FDA’s move.
“The United States lags behind many other countries that have nearly twice as many approved sunscreen ingredients,” the Academy highlighted.
“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,” added the organization.
Next steps
The FDA is now seeking public comments on the proposed order before issuing a final decision. Following the public comment period, if the FDA finds bemotrizinol meets GRASE criteria, it will be officially added to the sunscreen monograph.
