FDA Announces Changes to Sunscreen Labeling

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FDA Announces Changes to Sunscreen Labeling

"Broad-spectrum" protection is now strictly defined.

On June 14, 2011, the FDA issued long-awaited modifications to requirements for sunscreen labeling. Sunscreens can no longer be labeled "broad spectrum" unless they meet the FDA testing standards for ultraviolet (UV) A protection. Protection against UVA is not included in the sun protection factor (SPF) number. A sunscreen that meets UVA sun protection standards and has a UVB SPF of 15 or higher can maintain that it is "broad spectrum" and that it protects against skin cancer and limits skin photoaging. Sunscreens that provide UVA protection but have a UVB SPF of 2 to 14 can call themselves "broad spectrum" but must carry a warning that they do not protect against skin cancer or early skin aging. Sunscreens that are not broad spectrum must carry the same warning.

In addition, the terms "waterproof," "sweatproof" and "sunblock" are no longer allowed, because they imply a greater degree of protection than sunscreens can actually deliver. On the other hand, "water resistance" can be claimed if the duration of the effect (either 40 or 80 minutes) is specified. The FDA has also requested additional information on spray formulations, because their application differs from that of creams, oils, and lotions. The new regulations will take place in 2012 for most sunscreen makers, but smaller manufacturers will have an extra year to comply.

Comment: For decades, UVB SPF has been the FDA-approved gold standard for measuring and conveying the photoprotective strength of sunscreens. However, overwhelming evidence shows that UVA radiation also contributes to basal cell and squamous cell carcinoma, melanoma, and photoaging of the skin. The FDA changes are welcome and long overdue. Consumers have a bewildering number of sunscreen choices, and these modifications can better inform photoprotection choices. It is important to emphasize that sunscreens are effective for 2 to 3 hours only and must be reapplied. They should be used in conjunction with other measures, such as use of protective clothing and hats, limitation of outdoor activities during peak hours of UV intensity, restriction of activities to shaded areas when outdoors, and use of sunglasses.

— Craig A. Elmets, MD

Published in Journal Watch Dermatology June 15, 2011

Citation(s):

FDA announces changes to better inform consumers about sunscreen [press release]. Silver Spring MD: Food and Drug Administration (FDA); Jun 14, 2011. (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm258940.htm)

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