New Sunscreen Labeling Guidelines Issued by the FDA

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On June 14, 2011, the Food and Drug Administration announced significant changes to sunscreen labels to help reduce the confusion in “choosing the right sunscreen.” The changes will help the consumer make better choices when looking for a sunscreen to prevent and protect against sun induced aging and skin cancer.

Many physicians agree with the movement. In a recent clinical study, melanoma incidence has increased 45% between 1992 and 2004. Melanoma, once thought to be predominantly found in the elderly population, is now becoming increasingly common in the younger population. The president of the American Academy of Dermatology, Dr. Ronald Moy, has been recently quoted on ABC World News: “Now, melanoma is the most common form of cancer for young adults in their late 20’s.”

FDA label changes include:

  • Broad Spectrum Designation: Sunscreens that pass FDA’s broad spectrum test procedure, which measures a product’s UVA protection relative to its UVB protection, may be labeled as “Broad Spectrum” on the front label. For Broad Spectrum sunscreens, SPF values also indicate the amount or magnitude of overall protection. Broad Spectrum SPF products with SPF values higher than 15 provide greater protection and may claim additional uses.
  • Use Claims: Only Broad Spectrum sunscreens with an SPF value of 15 or higher can claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures. Non-Broad Spectrum sunscreens and Broad Spectrum sunscreens with an SPF value between 2 and 14 can only claim to help prevent sunburn.
  • Waterproof,” “sweatproof” or “sunblock” claims: Manufacturers cannot label sunscreens as “waterproof” or “sweatproof,” or identify their products as “sunblocks,” because these claims overstate their effectiveness. Sunscreens also cannot claim to provide sun protection for more than 2 hours without reapplication or to provide protection immediately after application (for example– “instant protection”) without submitting data to support these claims and obtaining FDA approval.
  • Water resistance claims: Water resistance claims on the front label must indicate whether the sunscreen remains effective for 40 minutes or 80 minutes while swimming or sweating, based on standard testing. Sunscreens that are not water resistant must include a direction instructing consumers to use a water resistant sunscreen if swimming or sweating.
  • Drug Facts: All sunscreens must include standard “Drug Facts” information on the back and/or side of the container.


What is the SPF Most Recommended by Dermatologists?


Most dermatologists agree that an SPF of 15 is the most minimal recommended strength, but an SPF 30 to SPF 50 is best. Keep in mind that the current SPF rating system only applies to UVB coverage (responsible for burning), and not UVA coverage (responsible for aging). While many thought the FDA would issue new guidelines to make it easier for consumers to choose a broad spectrum sunscreen, the FDA did not issue any label changes specifically addressing UVA coverage. For more details on the FDA recommended label changes, please visit the FDA’s Website and the American Academy of Dermatology’s Website.

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