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CFR - Code of Federal Regulations Title 21. Print; Share 1; E-mail 352.10 - Sunscreen active ingredients. § 352.20 352.50 - Principal display panel of all sunscreen drug products. § 352.52 - Labeling of sunscreen drug products. § 352.60
22 Nov 2016 The Sunscreen Innovation Act (SIA) was enacted on November 26, 2014 to provide an alternative process for the review of safety and
Nonprescription Sunscreen Drug. Products — Safety and. Effectiveness Data. Guidance for Industry. U.S. Department of Health and Human Services. Food and
11 May 2012 The US Food and Drug Administration (FDA) has issued its long-awaited new rules for sunscreen labeling enabling consumers to more easily
14 Jul 2017 Sunscreen: How to Help Protect Your Skin from the Sun . FDA regulations require all sunscreens and other nonprescription drugs to have an

Always read the label to ensure you use your sunscreen correctly, and ask a health care professional before applying sunscreen to infants younger than 6 months. In general, the FDA recommends that you use broad-spectrum sunscreen with an SPF of 15 or higher, even on cloudy days.
A labeling designation for sunscreen drug products to aid in selecting the type of .. with skin types I, II, and III using the following guidelines shall be selected:.
The 2011 sunscreen final rule applies to and Answers, in this guidance.
A. Yes. All products that claim to provide Broad Spectrum SPF protection are regulated as sunscreen drug products. Therefore, the regulations FDA has developed for OTC sunscreen drug products apply to cosmetics and moisturizers labeled with SPF values. A.

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March 2018