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The FDA’s New Regulation on Sunscreens: The 5 Changes Vital to Know

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We live in exciting technological times, and today a giant step was made in the right direction as the FDA acknowledged broad-spectrum (UVA and UVB) sunscreens with an SPF of 15 may reduce the risk of skin cancer.  The efficacy of sunscreens has been challenged by many in the past, as the sales of sunscreens seemed to increase at the same time as skin cancer diagnoses.  Yet, the popularity of tanning beds, the thinning of the ozone layer, as well as increased amount of time spent in the car or airplane (20-25% of UV rays penetrate through windows) are likely to be chiefly responsible for the 45% increase in melanoma diagnoses between 1992 and 2004 – not the chemicals in sunscreens, as some liked to propose.

There are five essential changes you’ll be introduced to within the next year.  Please note that many of the quotes are originally excerpted from today’s New York Times, in an article by one of my favorite science news writers, Gardiner Harris.

1.  Say goodbye to the words “waterproof” and “sweatproof.”

According to the Washington Post, “the agency is barring the use of the term ‘sunblock’ as well as claims that sunscreens are ‘waterproof’ or ‘sweatproof,’ saying those terms are inaccurate.” Under the new guidelines, only the terms “water-resistant for 40 minutes” or “water-resistant for 80 minutes” may be used.  Consumers will also be instructed to reapply the product after the time period.

2.  Say hello to formulas that must shield both UVA and UVB – or else they must include a warning label.

The best sunscreens block UV light in the UVB range (280-315 nm), as well as the UVA range (320-400 nm). A clever mnemonic for UVB and UVA is that B causes burning (erythema), whereas longer-wavelength A penetrates skin deeper, causing signs of aging. I should also note for the sake of accuracy (and my science-savvy readers) UVB also contributes to aging, as it induces matrix metalloproteinase (i.e, collagen-degrading) activity within the skin.

The AP reports that sunscreens must carry a warning label beginning in the summer of 2012 if sunscreens only protect against UVB rays, as some non-broad spectrum formulas currently do.  The warning will read as follows:

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.”

3.  Adopting Europe’s UVA (star-rating) and UVB (number-rating) dual system.

Americans have always known how strong our sun protection is based upon the UVB rating.  For instance, an SPF of 20 lets 5% of rays past (1/20 = 0.05 =  5%), while an SPF of 50 lets 2% past (1/50 = 0.02 = 2%).

However, for the past five years, European products have ranked UVA strength as well based upon a four-star system.  Only super UVA absorbers, like Tinosorb, received a rating of 4. According to chief health and medical editor Richard Besser, MD, in order to understand the four-star UVA system, “You need to go to a list put together by Consumer Reports specifically for products tested for UVA. By next year you’ll be able to trust the labels for everything.”

4.  Love your SPF over 50?  It may be hard to find (word’s still out).

In addition to the final regulations, FDA is considering a regulation that would require sunscreen products that have SPF values higher than 50 to be labeled as “SPF 50+.”   As I explained above, there is a huge difference between SPF 20 and 50 (SPF 20 lets 5% of rays past, while SPF 50 lets just 2% past).  But between SPF 50 and 75, for instance, there is only a 0.6% difference (2% versus 1.33%).  To protect the consumer from falsely believing they are immortally protected when wearing an SPF number higher than 50, “50+” would be adopted.  In addition, Dr. Warwick L. Morison, a professor of dermatology at Johns Hopkins University and chairman of the photobiology committee for the Skin Cancer Foundation, told The New York Times he was disappointed that the FDA failed to ban SPF numbers higher than 50 because such products expose people to more irritating sunscreen ingredients without meaningful added protection.

Personally, and meaning no disrespect to any dermatologists, I like to know as much as I possibly can about products.  I think adopting “50+” instead of “SPF [insert number above 50 here]” is underestimating the intelligence of consumers, who are not only capable of not only understanding the difference between SPF 50 and 70, but who also want to seek out this information (nearly 3 million views to this little blog tells me people seek to know everything they can)!  Furthermore, removing disclosure of the amount discourages manufacturers from producing an SPF any higher than the bare minimum to get the “50+” rating.  I don’t know about you, but I love my SPF 85 in the middle of July!  Fortunately, the FDA has not made a final decision about this as of yet.

5.  It’s not sunblock anymore – it’s sunscreen.

For about a decade, dermatologists have religiously avoided using the term “sunblock,” but it turns out manufacturers will have to do so too.  “Sunblock,” which prevents UV rays from penetrating the skin, is along the lines of most physical sunscreens, including zinc oxide, titanium dioxide, and others.  On the other hand, what used to be called “sunscreen” is now both physical sunscreens as well as chemical sunscreens, which absorb and then dissipate UV light into heat or light of longer wavelength that does not hurt the skin.  Chemical sunscreens, which include oxybenzone, avobenzone, and Parsol 1789, are sometimes preferred over physical sunscreens because they are often completely colorless and odorless. Unfortunately, the components in chemical sunscreens can also cause photoallergic contact dermatitis in susceptible patients.  In other words, if I have sensitive skin, I would use physical sunscreen.  Otherwise, I’d be using chemical sunscreens.  Also of interest:  Some ultra-devoted skin docs use both!

Further reading

Sunscreen is one of my favorite topics on Futurederm.com (and in life, really.  One time, I went to a nightclub with some friends, and they never took me again because I ended up discussing why sunscreen wouldn’t work properly on a skin graft with some resident from Philadelphia.  Seriously).  Anyway, I’m not usually that weird, just hopelessly devoted to my passion for skin care and beauty products – I promise.  🙂  Some other posts you might love:

If you wish to contact the government regarding the changes in sunscreens, please contact them via Regulations.gov here.

What are your thoughts on the new regulations?  Let us know in Comments below, or discuss on the Futurederm.com Facebook page!

Photo source: © kraska – Fotolia.com

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