Update on New FDA Sunscreen Regulations

The new FDA sunscreen labeling regulations have been delayed, and will not begin until December 17, 2012.  Originally slated to start last month, (June 2012) the FDA decided to give sunscreen manufacturers additional time to comply. According to the FDA, enforcing the change during the summer could create a sunscreen shortage.

Under the new regulations, sunscreen products that protect against both UVA and UVB rays will be labeled “Broad Spectrum” and “SPF 15” (or higher) on the front. On the back, the labeling will also tell consumers that “Broad Spectrum” and “SPF 15” or higher will protect against sunburn and can reduce the risk of skin cancer and early aging. Click here to see what the new labeling will look like regarding SPF 15 or higher.

By contrast, broad spectrum sunscreen below SPF 15, or is NOT broad spectrum, will be labeled as only protecting against sunburn. Click here to see a labeling example.

The final regulations will include these provisions. The following is a direct quote from the FDA: 

  • “Sunscreen products that are not broad spectrum or that are broad spectrum with SPF values from 2 to14 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.”
  • Water resistance claims on the product’s front label must tell how much time a user can expect to get the declared SPF level of protection while swimming or sweating, based on standard testing. Two times will be permitted on labels: 40 minutes or 80 minutes.
  • Manufacturers cannot make claims that sunscreens are “waterproof” or “sweatproof” or identify their products as “sunblocks.”   Also, sunscreens cannot claim protection immediately on application (for example, “instant protection”) or protection for more than two hours without reapplication, unless they submit data and get approval from FDA.” Source: FDA

I know these changes may seen confusing, but I think once in place, the labeling will help consumer make better informed choices. I also want to mention an ingredient in some sunscreens called “oxybenzone.” Certain consumer groups claim it is linked to hormone disruption, and can ultimately trigger skin cancer. The American Academy of Dermatology maintains it is safe, and provides effective broad spectrum protection.  “Available peer-reviewed scientific literature and regulatory assessments from national and international bodies do not support a link between oxybenzone in sunscreen and hormonal alterations, or other significant health issues in humans.” “Scientific evidence supports the benefits of sunscreen usage to minimize short- and long-term damage to the skin from UV radiation and outweighs any unproven claims of toxicity or human health hazard,” said Daniel M. Siegel, MD, FAAD, president of the Academy. I concur with that position. I recommend a broad spectrum sunscreen of 30 SPF or higher. Reapply it after swimming or exertion for 40 minutes.  We do sell high-quality professional grade sunscreens on my website, click here for information.  My signature brand, Melablock is made with micronized zinc oxide and antioxidants.  Larger sunscreen manufacturers will be making labeling changes this year, with smaller ones to follow next year. I will be very pleased to see these new labeling guidelines in place.

About Christine Brown, M.D.

Dr. Christine Brown operates a leading dermatology practice in Dallas, Texas. She understands the importance of good skin care and is committed to providing you with high-quality care in a pleasant and professional atmosphere. Services include clinical and cosmetic dermatology.
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