FDA Releases New Sunscreen Label Regulations


The Food and Drug Administration has issued new rules on sunscreen labeling to help consumers select products that prevent sunburn and reduce the risk of skin cancer and early skin aging.

The new labeling will differentiate sunscreen products according to their protective properties. Those products that meet FDA requirements of protection from ultraviolet A (UVA) and ultraviolet B (UVB) will be labeled "Broad Spectrum."

Photo courtesy FDA

UVA and UVB radiation are known to contribute to sunburn, skin cancer, and premature skin aging. Under the new rules, only products that qualify as broad spectrum and have SPF values of 15 (or higher) can include labeling that the product helps prevent skin cancer and reduces the risk of early skin aging. Other products with SPF values between 2 and 14 may be labeled broad spectrum if they meet FDA tests for UVA and UVB protection, but will be required to have a warning stating that the product has not been shown to prevent skin cancer or early skin aging.

"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 Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "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."

The new regulations will go into effective in 1 year for most manufacturers. Other sunscreen makers with annual sales of less than $25,000 will have 2 years to comply with the new rules.

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