Tuesday, May 17, 2011

Sunscreen is an OTC Drug

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Q: I want to offer a natural sunscreen as part of my product line, but I'm not sure where to start. Do you have any suggestions? Carol A., Chicago, IL

A: The best place to start is with the FDA website regarding Sunscreens in cosmetics. Use of the term "sunscreen" or similar sun protection terminology in a product's labeling generally causes the product to be subject to regulation as a drug. However, sunscreen ingredients may also be used in some products for nontherapeutic, nonphysiologic uses (for example, as a color additive or to protect the color of the product). To avoid consumer misunderstanding, if a cosmetic product contains a sunscreen ingredient and uses the term "sunscreen" or similar sun protection terminology anywhere in its labeling, the term must be qualified, in accordance with 21 CFR 700.35(b), by describing the benefit to the cosmetic product provided by the sunscreen ingredient (for example, "Contains a sunscreen to protect product color."). Otherwise, the product may be subject to regulation as a drug [21 CFR 700.35]. For further information on sunscreens, refer to Tanning Products.

Rulemaking History for OTC Sunscreen Drug Products

Allison B. Kontur
www.BathBodySupply.com

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