FDA proposes updating sunscreen regulatory requirements

Whether you’ve been a longtime patient or a new one, you know our mantra – “Protect your birthday suit…use sunlock daily.”

Now, the U.S. Food and Drug Administration (FDA) has issued a proposed new rule that outlines the final detailed written study or monograph for over-the-counter (OTC) sunscreen products. It’s important for everyone to take notice.

The goal of the sunscreen monograph is to update nonprescription, OTC sunscreens – those that are marketed in the United States and grandfathered in without FDA-approved applications – to ensure that consumers have access to sun protection options that are considered safe and effective.

The proposed rule identified two ingredients – zinc oxide and titanium dioxide – as “Generally Recognized As Safe and Effective” (GRASE), and two others – PABA and trilomine salicylate – as not GRASE.

For an additional 12 ingredients, including oxybenzone, the FDA indicated that there is insufficient evidence to conclude that these ingredients are GRASE. However, in the proposed rule the FDA stated that this designation does not indicate these ingredients are unsafe for use in sunscreen, an assertion being made by the Environmental Working Group. The FDA is asking for more testing of these 12 ingredients.

In addition, the proposal puts forward a recommendation on SPF values on sunscreen labels, including raising maximum SPF from 50+ to 60+.

“Because sunscreen is an important tool in the fight against skin cancer, the American Academy of Dermatology Association (AADA) supports any and all regulations to ensure that the public has access to safe and effective sunscreens.

“We are encouraged that the FDA is taking this action on the Sunscreen Innovation Act, and we look forward to working with the FDA as it develops and finalizes the proposed rule,” said AAD President Suzanne M. Olbricht, MD, in a statement regarding the proposal.

“As the proposed rule is finalized, we encourage the public to continue protecting themselves from the sun’s harmful ultraviolet rays.” She added, “If you are concerned about the safety of the ingredients in your sunscreen, talk to a board-certified dermatologist to develop a sun protection plan that works for you.”

The AADA is currently reviewing the proposed rule and will submit comments to the FDA. The AADA continues to engage with the FDA to discuss our shared interest in promoting access to new sunscreen ingredients, including new and advanced UV filters, many of which are already available in other countries.

And, once again, please remember to “Protect your birthday suit…use sunlock daily.”