FDA Updates Sunscreen Regulations

Jun 16, 2011 1 Comment by

In case you haven’t heard, on Tuesday, June 14, The Food and Drug Administration (FDA) announced new guidelines that sunscreen manufacturers will be required to follow for sunscreen labeling in order to help protect consumers from skin damage caused by sun exposure. Beginning summer 2012 the new rules dictate that in order to earn a “broad spectrum” designation, sunscreens must protect from both UVB rays, which cause burning, and UVA rays, which cause wrinkles.

 

New FDA Sunscreen Guidelines

Here’s what you need to know about the new Broad-Spectrum labeling.  An example of the new FDA label is pictured above.

 

  • Established standards have been set for testing the effectiveness of over-the-counter sunscreens and will be labeled as “Broad- Spectrum” according to the test results.
  • A certain percentage of a broad-spectrum product’s total protection is against UVA.
  • If a sunscreen is labeled as both “Broad-Spectrum” and “SPF 15” (or higher) it can claim to protect against sunburn and if used as directed, can help reduce the risk of skin cancer and early skin aging.
  • The familiar “Drug Facts” box found on most OTC drugs will be required.
  • 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.
  • Sunscreens that are not broad-spectrum or that are broad-spectrum with SPF values less than 15 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.”
  • No “waterproof,” “sweatproof” or “sunblock” labeling.  Water resistant labeling is allowed with SPF effectiveness times of only 40 or 80 minutes.
  • Sunscreens cannot claim protection immediately upon application (instant protection) or for more than 2 hours without reapplication, unless they submit data and get approval from FDA.
  • The FDA is proposing that the maximum SPF value on labeling is SPF 50+.
  • The agency currently considers wipes, towelettes, powders, body washes, and shampoo not eligible for the monograph. Therefore, they cannot be marketed without an approved application.


Guaranteed Broad-Spectrum Sunscreens from Coolibar

Hooray to the FDA for finally making these necessary improvements to sunscreen labeling.  If, however, the new guidelines seem overwhelmingly complex, let Coolibar take the guesswork out of your next sunscreen purchase.  Our merchandising team has researched and tested the best sunscreens on the market.  As always, we offer only broad-spectrum sunscreens with at least an SPF of 30 or higher.  You can trust that any sunscreen you purchase from Coolibar will provide both UVA and UVB protection; you have our word on it.  And when combined with a hat, Coolibar clothing and sunglasses, you’re equipped for all day, worry-free UV protection.


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