Don’t Expect Guidance on Sunscreens — FDA Drops the Ball Again : Exclusive Renegade Health Article

Monday Jun 18 | BY |
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Which is best? Don’t count on the FDA to help you decide.

Almost exactly a year ago, the FDA announced new requirements for over-the-counter sunscreen products. After years of waiting, the agency put together new rules that would enable consuemrs to more easily select the right sunscreens for them, and to determine which products would more effectively protect against skin cancer.

When the FDA announced these new regulations, a lot of people and organizations applauded them. Dermatologists noted how the current sunscreen landscape is horribly confusing for consumers, with each brand making its own claims, and a lot of those claims meaning next to nothing when it comes to true skin protection.

The new regulations were supposed to go into effect this summer (2012). Well, guess what? I know you won’t be surprised. There’s been a delay! According to recent reports, the FDA is backing off and allowing sunscreen manufacturers “more time” to make changes. Apparently a year wasn’t enough. As usual, the consumers are the ones who will pay the price, having to go through another summer unsure whether or not their sunscreen is actually protecting them.

Outline of New Regulations
The new regulations were intended to create new product labels that would be easier to understand. Current regulations deal mostly with protection against sunburn, primarily caused by UVB radiation from the sun. They didn’t address UVA radiation, which contributes to skin cancer and premature aging. Now the FDA has a test that can establish whether or not a particular sunscreen provides “broad-spectrum” (UVA and UVB) protection, which they plan to use to even the score among brands.

The new regulations will be as follows:

  • Broad-Spectrum: Sunscreens that haven’t passed the test will no longer be able to make this claim.
  • Use Claims: Only those sunscreens offering broad-spectrum protection with an SPF value of 15 or higher can make claims about protecting from skin cancer and premature aging. Those with an SPF below 15 can only claim protection against sunburn.
  • Waterproof, Sweat Proof, and Sunblock Claims: These claims will no longer be allowed. Manufacturers will also not be able to claim that their products offer protection for more than two hours without reapplication, or that they offer “instant” protection, unless they submit scientific data to the FDA supporting those claims, and that data is approved.
  • Water-Resistance Claims: These claims must indicate whether the sunscreen is still effective for 40 minutes or 80 minutes while swimming or sweating, based on standardized testing. Those products that aren’t water-resistant have to direct consumers to use a water-resistant product if swimming or sweating.
  • Drug Facts: All products must contain the standard “drug facts” on the back or side of the container.

In addition, the FDA is still considering data on the effectiveness and safety of spray sunscreens (including risk of inhalation). It’s also considering capping claims for SPF to no more than 50, and is reviewing the safety of certain sunscreen ingredients, like nanoparticles.

FDA Bows to Industry Pressure
According to Forbes magazine, these new regulations took 34 years of study and deliberation to develop. (Who said the FDA was speedy, right?) But on May 11, 2012, the agnecy announced it will push back the enforcement of the new rules until mid-December 2012—long after this summer sun season is over. Smaller manufacturers will have even longer—until December 2013.

The Personal Care Products Council requested the additional time, stating that changing labels of thousands of products “is a huge undertaking,” and that the FDA usually gives them more time to implement these things. Because manufacturers were behind, they claimed that had the FDA gone ahead with the regulations, they may not have been able to keep up with demand this summer, and many consumers may have had to go without their sunscreen entirely.

Critics say the step backwards means that more consumers will likely get burned, putting themselves at risk of skin cancer this summer.

What Can You Do?
While the manufacturers slowly roll out new products with label changes, consumers are left to navigate the overwhelming world of sunscreen labeling on their own. Here are a few tips to make sure you and your family are protected:

  • Old-fashioned sunscreens made with zinc oxide (and titanium dioxide, as a second option) are still considered the safest options—as long as these ingredients are not present in nanoparticles. There is some concern that nanoparticles may be small enough to penetrate the skin and get inside the body, where they could increase health risks. How can you tell? You won’t find any help on the label—the FDA has set no standards for nanoparticle claims or sizes. All you can do is research the brand. Go with organic and natural manufacturers who care about such things.
  • Avoid chemical sunscreens like oxybenzone and octylcrylene and the like. There is some evidence that these types of sunscreens may generate free radicals when exposed to UV rays, accelerating skin aging and potentially leading to DNA changes.
  • Avoid the direct sun between 10:00 a.m. and 4:00 p.m., or cover up with light clothing, broad-brimmed hats, sunglasses, and umbrellas.
  • Reapply sunscreen (no matter what it says) every two hours—more often if you get sweaty or wet.
  • Use a product with an SPF of at least 30. (Note that products labeled higher than 50 may offer no additional protection.)
  • Supplement with beta-carotene and vitamin E to diminish your body’s sensitivity to UV light.
  • Green tea may provide natural sun protection—drink a cool glass before going out.
  • Keep skin moisturized—moisturized skin is less susceptible to damage than dry skin. Try jojoba oil, shea butter, aloe vera, and emu oil, which all also offer some sun protection.
  • Check out the Environmental Working Group’s Sunscreen Guide—it may help narrow down your product choices.

What do you think about the FDA’s delay? How are you planning on protecting your family this summer?

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Photo courtesy Joe Shiabotnik via

Lauran Neergaard, “FDA Delays Rules Meant to Ease Sunscreen Confusion,” Associated Press, May 11, 2012,

Carrie Printz, “Dermatology Community Applauds New FDA Sunscreen Regulations,” Cancer, January 2012, Volume 118, Issue 1, PP 1-3.

Amy Westervelt, “FDA Delays Implementation of New Sunscreen Regulations Until After Summer,” Forbes, May 11, 2012,

Kevin Gianni

Kevin Gianni is a health author, activist and blogger. He started seriously researching personal and preventative natural health therapies in 2002 when he was struck with the reality that cancer ran deep in his family and if he didn’t change the way he was living — he might go down that same path. Since then, he’s written and edited 6 books on the subject of natural health, diet and fitness. During this time, he’s constantly been humbled by what experts claim they know and what actually is true. This has led him to experiment with many diets and protocols — including vegan, raw food, fasting, medical treatments and more — to find out what is myth and what really works in the real world.

Kevin has also traveled around the world searching for the best protocols, foods, medicines and clinics around and bringing them to the readers of his blog — which is one of the most widely read natural health blogs in the world with hundreds of thousands of visitors a month from over 150 countries around the world.

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