Cosmetic

FDA take aim at improving quality, safety, and efficacy of sunscreens

The provisions in the proposed order are substantively the same as those described in the FDA’s 2019 proposed rule on sunscreens and are aimed at bringing sunscreens that are marketed without FDA-approved applications up-to-date with the latest science to better ensure consumers have access to safe and effective sunscreen products, stated the Agency in a release.

“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, M.D.

“[Our new] 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.”

CARES

The way sunscreens marketed without approved applications are regulated in the US were reformed and modernized under the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act.

The Act establishes a deemed final order for sunscreens, which, along with other requirements established by the CARES Act, sets the current requirements for marketing these OTC sunscreen products.

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