FDA takes steps to improve quality, safety of sunscreens

FDA is working to improve the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain OTC drugs.

In the short-term, these new authorities essentially preserve status quo marketing conditions for these sunscreens. However, the agency recently proposed revisions and updates to those requirements that are related to maximum 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,” said Acting FDA Commissioner Janet Woodcock, MD. “[This] represents 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.”

This order regarding sunscreen includes certain requirements about active ingredients from the 1999 final monograph regulation for OTC sunscreen products, which never took effect. It also includes labeling and effectiveness requirements from a final 2011 labeling and effectiveness testing rule and proposes updates to how products are labeled to make it easier for consumers to identify key product information. The agency will consider comments on the proposed order submitted during a 45-day public comment period before issuing a revised final order.