Changes to US Sunscreen Regulations

The newest regulations and comments on sunscreens from the US Food and Drug Administration (FDA) were officially published in the Federal Register on June 17, 2011, and will go into effect June 17, 2012. The final rule titled Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use amends the Final Monograph that went into effect in May 1999 but has been stayed until now. Parts are still stayed until the FDA issues further rules. The recently published regulations are a small part of the overall regulations; therefore, this column will clarify the overall regulations by reviewing the full picture—sunscreen drugs, labeling, registrations and unanswered questions.

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