FDA Proposes Allowing New Sunscreen Ingredient

 The FDA has proposed adding bemotrizinol as a new active ingredient allowed in sunscreens, in a move it says will "advance sunscreen innovation."

This move is part of a broader initiative in the Office of Nonprescription Drugs, according to the FDA news release. Bemotrizinol is an ultraviolet light filter and features in many popular Asian, European, and Australian sunscreens.

"Based on the data reviewed by the FDA, bemotrizinol provides protection against both ultraviolet A and B rays, has low levels of absorption through the skin into the body, and rarely causes skin irritation," the release stated.

FDA Commissioner Marty Makary, MD, MPH, said that the FDA historically has moved too slowly in the sunscreen space, "leaving Americans with fewer options than consumers abroad."

"We're continuing to modernize the regulation of sunscreen and other over-the-counter drug products," he added.

Two main types of ultraviolet filters are used in sunscreens in the U.S.: chemical and mineral. Chemical sunscreens typically include at least one active ingredient such as oxybenzone, octinoxate, cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octisalate, or octocrylene. Mineral sunscreens typically contain zinc oxide or titanium dioxide.

Sunscreens are considered over-the-counter (OTC) monograph drugs, which can enter the market without an approved drug application if the drug meets certain requirements established in its monograph, such as for permitted active ingredients, uses, and doses. Companies kick off the process by submitting an OTC monograph "order request."

Manufacturer DSM Nutritional Products submitted a request that FDA "add bemotrizinol, at concentrations up to 6%, as a new active ingredient in the OTC monograph for sunscreens," according to the release. Though used in sunscreens abroad, the FDA has not previously approved an application for a drug product containing bemotrizinol or added the ingredient to the sunscreen monograph.

FDA is seeking public comments on its proposal via the Federal Register.

The American Academy of Dermatology (AAD) in a press release applauded the FDA "for taking the first steps in more than two decades to provide more safe and effective sunscreen options to the American public," noting that AAD has been advocating for more sunscreen options for years.

"The United States lags behind many other countries that have nearly twice as many approved sunscreen ingredients," the release stated.

Korean sunscreens in particular have garnered a cult following in recent years, with people praising what they say are better formulations than most sunscreens available in the U.S. Tariffs, however, have made some foreign sunscreens more difficult to get.

https://www.medpagetoday.com/dermatology/generaldermatology/118962