New Regulations Will Clarify Sunscreen Labels

Having only an SPF of 30, dare 15, warrants the occasional glare or snarl from other the parents who, apparently, have been bamboozled by clever marketing to believe there is a difference in SPF’s of 50, 70 and 100 or that their chosen brand of sunscreen effectively blocked cancer causing UVB and UVA rays while protecting their child from sun burn. This is just a false sense of security, though. 

“There is no evidence that SPF values greater than 50 provide any additional benefit,” said FDA dermatologist Jill Lindstrom.

On June 17, the Food and Drug Administration (FDA) published the Final Rule concerning the labeling and effectiveness of over-the-counter sunscreen the changes of which attempt to help consumers make sense of confusing labels that promise maximum SPF’s to protect against skin cancer, aging and, of course, sunburn.

According to the FDA, the SPF is meaningless if it does not pass the broad spectrum test, which measures the UVA protection relative to the UVB protection. Products labeled SPF will not be able to claim that they reduce the risk of cancer or skin aging, only those products labeled “Broad Spectrum SPF” of 15 or higher will be designated as such. Products not labeled "Broad Spectrum" or with an SPF between 2 and 14 can only claim to prevent sunburn.

No products will be able to claim the identifications of water proof, sweat proof or sunblock.  Sunscreens cannot claim to work for more than 2 hours without reapplication. Waterproof will be replaced by the term water resistant but products labeled water resistant must indicate the duration of effectiveness on the label and can only achieve that label after presenting information to the FDA for approval.

 “Always follow the direction,” said Lindstrom, “this includes applying and spreading it on thoroughly, reapplying every 2 hours or more if sweating or jumping in and out of the water.”

According to the Environmental Working Group, these regulations are 33 years too late and would allow most products to use the label “broad spectrum sunscreen.” If most products are able to use the label, the regulations do little to alleviate any confusion.

“FDA's action offers some noticeable improvements for consumers, such as limiting misleading claims” said David Andrews, Ph.D, a senior scientist with EWG. “However, it is clear that FDA caved to industry and weakened its safety standards. Its [2007] draft proposed stronger health protections.”

The chemical formulas of sunscreens can be either mineral or non-mineral formulations as well as any combination thereof in their active ingredients.  While the former incorporates zinc oxide or titanium dioxide, which can  be toxic if they penetrate the skin, they offer stronger UVA protection that is rare in non-mineral based sunscreens. 

Non-mineral sunscreens may contain oxybenzone which can cause allergic reactions or act as a potential hormone disruptor if it penetrates the skin in large quantities.  Experts raise concerns about oxybenzone because studies show that it does penetrate the skin and is one of the most common active ingredient in 60% of the sunscreens tested by EWG.

Yet, another ingredient of concerned to EWG is retinyl palmitate, a form of vitamin A used in sunscreens as an anti-aging agent. An FDA study has been shown the ingredient to stimulate lesion and tumor growth in direct sunlight when tested on lab mice. 

Consumers should be aware that these chemicals are in sunscreens on the labels, but, EWG feels that the benefit of UVA protection in the mineral based sunscreens outweighs the possibility of penetrating the skin, contending that most studies show that they don't penetrate the skin according to EWG. 

In a written statement, EWG said that their analysis “indicates that consumers who use sunscreens without zinc and titanium are likely exposed to 20 percent more UVA radiation and greater numbers of hazardous ingredients than consumers relying on these mineral products for sun protection.”

The ultra-violet rays of the sun wreak havoc on the skin and more information is emerging all the time along with improvements that develop to protect against UVA and UVB rays. According to the Skin Cancer Foundation, UV rays contribute to melanoma, the deadliest form of skin cancer, killing more than 8,000 Americans each year, as well as nonmelanoma skin cancers, afflicting over 250,000 Americans.  Even though some sunscreens promise UVA and UVB protection, all the protection in the world is not going to help unless the sunscreen is applied thoroughly.

The EWG has a Hall of Shame for those sunscreens that make the grade as well as a listing of the Best Beach and Sports Sunscreens gathered from the over 500 sunscreens they tested in the their labs. Alba Botanica, Aveeno and Blue Lizard are listed as some of the best while you will find Coppertone, Banana Boat or Hawaiian Tropics in the hall of Shame.

It seems that the FDA is taking a step in the right direction by helping consumers reduce the confusion in reading labels but, these new changes won’t even take effect until June 18, 2012. This gives the FDA a great deal of time to enforce the changes on the sunscreen manufacturers as well as make stronger regulations.

The FDA has offered these guidelines for the prevention of sun burn, cancer and aging caused by excessive exposure to the sun.  

Prevention Guidelines

• Seek the shade, especially between 10 AM and 4 PM.
• Do not burn.
• Avoid tanning and UV tanning booths.
• Cover up with clothing, including a broad-brimmed hat and UV-blocking sunglasses.
• Usa a broad spectrum (UVA/UVB) sunscreen with an SPF of 15 or higher every day. For extended outdoor activity, use a water-resistant, broad spectrum (UVA/UVB) sunscreen with an SPF of 30 or higher.
• Apply 1 ounce (2 tablespoons) of sunscreen to your entire body 30 minutes before going outside. Reapply every two hours, or immediately after swimming or excessive sweating.
• Keep newborns out of the sun. Sunscreens should be used on babies over the age of six months.
• Examine your skin head-to-toe every month.
• See your physician every year for a professional skin exam.