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FDA & Sunscreen Labeling

FDA and Sunscreen Labeling
The sun protection factor (SPF) test is, and should remain, the singular in vivo method for evaluating sunscreens, and it should be communicated to consumers as an SPF no greater than 50. We now know that it is the long ultraviolet rays (UV-AII and UV-AI) that are responsible for photoaging and some skin cancers. Until recently, many over-the-counter sunscreens did not protect against long-wavelength UV-A (UV-AI) insults. For some time, the American Academy of Dermatology has endorsed a critical wavelength of 370nm as a measure of effective UV-A protection, and recommended that the FDA use this as a requirement for those sunscreens labeled as providing “Broad Spectrum” coverage. This would lend credibility to the term “Broad Spectrum”, and ensure that these sunscreens provide adequate protection against both UVB and UBA rays.

The Food and Drug Administration (FDA) has finally taken steps related to sunscreen labeling that provide better protection for consumers. These regulations establish standards for testing the effectiveness of sunscreen products, and require labeling that accurately reflects those test results. These regulations include a better definition for the term “Broad Spectrum” protection, place a maximum SPF value on sunscreen labeling that now cannot exceed “SPF 50+”, and provide more accurate labeling that reflects the water resistance of the product. This new information should help consumers understand which products offer the best protection from the harmful rays of the sun.

The FDA’s Final Regulations
The final regulations, which became effective June 18, 2012, establish a standard test for over-the-counter sunscreen products that determines which products are allowed to be labeled as “Broad Spectrum.” The final compliance date for this labeling was December 17, 2012.

Products that pass the broad spectrum test will provide protection against both UVB and UVA radiation, and will be rated SPF 15 or higher. The front of the packaging will indicate this with the words “Broad Spectrum” and the “SPF (15 or higher)”. On the back of the package there will be an indication that a broad spectrum sunscreen not only protects against sunburn, but, if used as directed with other sun protection measures, can reduce the risk of skin cancer and early skin aging.

By contrast, any sunscreen not labeled as “Broad Spectrum” or that has an SPF value between 2 and 14, has only been shown to help prevent sunburn. These sunscreens will be labeled with a warning that reads: “Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.”

The term “Waterproof” will now be replaced by “Water resistance.” The “Water resistance” claims on the product’s front label will indicate the amount of time a user can expect to get the declared SPF level of protection while swimming or sweating, based upon standard testing. Only Two water resistance times will be permitted on labels: “40 minutes” or “80 minutes”. After water immersion or sweating for this time period, reapplication of the sunscreen is necessary to continue the specified SPF rating of coverage.

Manufacturers can no longer make claims that sunscreens are “Waterproof” or “Sweatproof” or identify their products as “Sunblocks.” In addition, sunscreens cannot claim protection immediately on application (for example, “instant protection”) or protection that lasts for more than two hours without reapplication, unless they submit data and get approval from FDA.


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