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New Sunscreen Regulations

The FDA recently changed the regulations for sunscreen manufacturers. Here's what’s changing and what’s missing, and what it means for you.
posted: 07/19/2011
sunscreen

When it comes to nutrition, what goes on your skin is almost as important as what goes in your mouth. Skin can absorb up to 60-100 percent of what is applied—that’s why Nicotine and progesterone patches work—so knowing what you’re slathering on is a big deal. The good news is, this will get a little easier thanks to the Food and Drug Administration’s (FDA) June announcement of new labeling requirements for over the counter sunscreens. The bad news is despite new policies—updated for the first time in over 30 years—questionable ingredients went unaddressed.

Here are the details on what’s changing, what they missed, and the best products to protect your skin this summer.

In effort to support the FDA’s “ongoing efforts to ensure that sunscreens meet modern-day standards for safety and effectiveness” the new rulings impose a number of labeling, testing, and formulation requirements. It will take effect for most manufacturers in June 2012, while companies with annual sales less than $25,000 will have an extra year.

These are basically the three main points to the new regulations, full details at FDA.gov 

Broad Spectrum & Use Claims. Sunscreen products will have to protect against both UVA and UVB rays equally to be able to carry the “broad spectrum” label. Sunscreens with an SPF of 15 or higher can claim they help prevent sunburn, reduce the risk of skin cancer, and skin aging, while sunscreens that don’t meet the broad spectrum standards or are broad spectrum with an SPF lower than 15 will have to carry warnings stating the product has not been proven to protect against early skin aging and skin cancer.

Water, Sweat & Sunblock Claims.  Manufacturers will no longer be allowed to label sunscreens as waterproof, sweatproof, or identify their products as sunblocks because these claims “overstate their effectiveness.”  Moreover “water resistance” claims must indicate whether the sunscreen remains effective for either 40 minutes or 80 minutes while swimming or sweating, based on testing.

Drug Facts. All sunscreens must include standard "Drug Facts" information on the back and/or side of the container. Yes, over-the-counter sunscreens are considered a drug.

Here’s where we get into the rub. There are currently 16 active ingredients allowed for use in sunscreens by the FDA and a slew of inactive ingredients. However, many of these approved ingredients have never been safety tested. Here are two ingredients that the FDA missed the boat on reviewing this year, which have spurred widespread public criticism.

Oxybenzone (also known as benzophenone-3 or BP): is an approved active ingredient used in 60 percent of sunscreens available in the U.S. A 2008 study by the U.S. Centers for Disease Control (CDC) concluded that 97 percent of Americans are contaminated with oxybenzone based on an analysis of more than 2,500 urine samples. In their most recent publication, the Environmental Working Group, a non-profit that compiles an annual sunscreen safety report provided a raft of studies that link oxybenzone to allergies, “notorious” hormone disruption (increased estrogenic activity, specifically), and cell damage. Despite the pervasive ability for this ingredient to absorb into the skin, the FDA has no plans to test its safety.

Retinyl palmitate is a vitamin A derivative often found in sunscreens and other skin care products. Despite clinical evidence linking topical use of retinyl palmitate to skin cancer, the FDA remains mum. The most recent government scientific study, made public last January by the National Toxicology Program (NTP), demonstrated that retinyl palmitate speeds photo-carcinogenic effects on test animals. A panel of independent scientists convened by the NTP unanimously confirmed the study’s conclusion that retinyl palmitate “enhanced the photocarcinogenic activity” of sunlight.

Are there any good options? Yes. According to the EWG’s 2011 analysis of sunscreens which includes safety and effectiveness ratings, the brands that scored best based on health hazards associated with listed ingredients, UVA and UVB protection, and how quickly a sunscreen ingredient breaks down in the sun are:

  • Aubrey Organics
  • All Terrain
  • Badger

This summer, take the few extra minutes to read the labels on your sunscreen. Your skin will thank-you.

 

Jess Kelley, MNT, is a Master Nutrition Therapist and has completed over 500 hours of nutrition education at the Nutrition Therapy Institute in Denver, Colorado. She has a private practice in southwest Colorado called Durango Nutrition where she specializes in food allergies and hormone balance. Jess has a BA in Journalism and is currently the Managing Editor for Edible San Juan Mountains Magazine. She can be reached at jess@durangonutrition.com.

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