FDA Takes Steps Aimed at Improving Quality, Safety and Efficacy of Sunscreens

Posted By American Med Spa Association, Friday, October 1, 2021

The U.S. Food and Drug Administration today took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs.

In the short term, these new authorities essentially preserve status quo marketing conditions for these sunscreens. However, the agency today proposed revisions and updates to those requirements related to maximum sun protection factor (SPF) values, active ingredients, broad spectrum requirements, and product labeling, among other provisions.

"Sun safety is important for everyone, regardless of your skin tone. Americans can reduce risks from sun exposure with continued use of sun protection measures including broad spectrum sunscreen with SPF values of at least 15," says Acting FDA Commissioner Janet Woodcock, M.D. in a news release. "Today's activities represent a key milestone in our implementation of transformative new authorities related to OTC drugs that will allow us to continue ensuring that sunscreens are safe and effective for frequent, life-long use and provide consumers with the protection they expect from these products. We are committed to using our new authorities to help meaningfully advance innovative, safe and effective options for consumers and secure a robust OTC marketplace."

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