FDA Greets Summer with New Sunscreen Labeling Rules and More

FDA is undertaking new strategies to inform consumers about sunscreen products, issuing a final rule, looking into a new one, and providing new guidance.

The agency has finalized regulation regarding labeling statements that can be made about passing FDA’s test for protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays. Products that have passed can be labeled as “Broad Spectrum,” FDA reports on its Web site.

“FDA has evaluated the data and developed testing and labeling requirements for sunscreen products, so that manufacturers can modernize their product information and consumers can be well-informed on which products offer the greatest benefit,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, in a statement on FDA's site. “These changes to sunscreen labels are an important part of helping consumers have the information they need so they can choose the right sun protection for themselves and their families.”

In addition to the sunscreen labeling rule, FDA has produced three additional regulatory documents as detailed on FDA's site:

  • A proposed rule limiting the maximum SPF value on sunscreen labels to “50 +”, because there is not sufficient data to show that products with SPF values higher than 50 provide greater protection for users than products with SPF values of 50, FDA writes. Data to support including higher SPF values in the final rule are welcomed.
  • An Advance Notice of Proposed Rulemaking (ANPR) for Dosage Forms regarding sunscreen sprays. Data on their safety and effectiveness are welcomed as are comments on possible directions and warnings.
  • Draft Enforcement Guidance for Industry outlining information to help sunscreen product manufacturers understand how to label and test their products in light of the new final rule and other regulatory initiatives.

For more information on what "Broad Spectrum" really means and the warning products need to carry if they do not meet the definition, visit www.fda.gov/sunscreen 

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