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Only on Dr. Jeffrey Dover, MD, Explains New FDA Guidance on OTC Topical Acne Products

Posted: July 20, 2011

The U.S. Food and Drug Administration (FDA) announced final guidance for industry on over-the-counter (OTC) topical acne drug products, which was initially proposed in 1985.

In summary, the guidance:

  • Requires labeling on benzoyl peroxide products, stating that they should be used with sunscreen.
  • Adds benzoyl peroxide as generally recognized as safe and effective active ingredient in OTC topical acne drug products.
  • Outlines new warnings (i.e., the products should not be used on broken skin and warnings about potential skin irritation).
  • Revises labeling requirements for all OTC topical acne drug products, to ensure consistency with the standardized Drug Facts formatting and requirements.
  • Permits the use of single and combinations of active ingredients. Could you explain the new U.S. Food and Drug Administration (FDA) over-the-counter acne product guidelines and spell out what it means for consumers?

Jeffrey Dover, MD, past president of the American Society for Dermatologic Surgery (ASDS): It is important to use benzoyl peroxide with sunscreen because benzoyl peroxide is photosensitive. Fair skin individuals are particularly at risk.

No matter what your skin type or how your body reacts to the sun, you should always wear sunscreen with an SPF of 30 or higher. The ASDS recommends applying about one ounce (the size of a shot glass) of sunscreen to cover your entire body and reapply every two to three hours spent outdoors.