What SNEWS found in our exclusive, in-depth, three-part investigation into the world of sunscreen, FDA oversight, marketing and manufacturing that ran May 26 (part 1), May 28 (part 2) and May 31 (part 3) stunned us: The U.S. Food and Drug Administration, which oversees over-the-counter drugs including sunscreen, has been unable to pass some of the most basic regulations for 32 years since it first broached the topic of sunscreen. Meanwhile, we are all left confused about what we should know, use, ask or even believe. Forget the risk of early skin aging and wrinkles. The dangers are in the risk of deadly melanoma cancer. Below, we offer some additional information to help in your education to protect your customers and yourself.
What’s the FDA up to?
The FDA’s proposed rule list includes research, proposals and public meetings for two ingredients (avobenzone and zinc oxide), about the combination of insect repellent with sunscreen (currently not officially allowed or actually overseen), and for UVA protection claims and ratings (no final guidelines). In addition, although not on the list but questioned for health reasons, is the use of oxybenzone and nano-particles (both considered possible health risks). In sum, what the FDA is still looking at:
Avobenzone is an approved active UVA-blocking ingredient, but it breaks down quickly in the sun and in packaging. Sunscreens that have it must have appropriate stabilizing compounds for it to retain effectiveness. It is considered a less-risky UVA blocker, if that is reassuring, but it can burn your eyes if it runs.
Insect repellent/sunscreen combinations leave two government agencies, the FDA and EPA, trying to work together. So far, it hasn’t resulted in much we can use. Are we surprised? That means the combo-pack is unapproved. Experts say that if you use as much sunscreen as you should and you reapply sunscreen as often as you should, you’ll be infusing your skin with way too much insect repellent.
Nano-particles and their safety are still up in the air since the smaller a compound’s particles are, the more the compound may be absorbed by the skin and become a health risk. So far, the risk may only lie in their use in sprays since the particles are more easily absorbed via the lungs. Although there are no final decisions or research on this yet and many are skeptical of any risk, a study out of Australia released in February 2010 indicated that people who use a lot of sunscreen did risk having larger quantities of zinc nano-particles absorbed by the body – and they could remain there for a very long time. But even study researcher and geochemist Brian Gulson told SNEWS in an email interview the amount was “quite tiny,” and it was unknown whether it was due to absorption or whether it reflected a reaction of the zinc oxide with the lower pH of the skin. Plus, there is no real evidence about what damage it could cause on cells or the immune system – yet.
Oxybenzone, currently approved and offering some UVA protection, is considered by some to be a hormone disrupter that may cause cell damage. The EWG suggests it be avoided, and many better sunscreen brands have or are phasing it out, while other manufacturers say the claims are exaggerated. It can also be more of a skin and mucous-membrane irritant than others.
UVA protection, i.e. making a sunscreen able to block both the burning UVB rays and the cancer-causing UVA rays (known as broad-spectrum), is not currently overseen to determine if the ingredients, the quantity of ingredients, the labeling or the claims of protection are valid. In 2007, an FDA release noted a rule’s effective date was deferred “for future regulatory action because more time was required to review comments from interested parties.”
Zinc Oxide is also an approved active ingredient for blocking both UVA and UVB. The proposed rule discusses the level of zinc needed to be able to make broad-spectrum claims and that it would need to pass “yet-to-be-established” UVA testing procedures.
Overall, the FDA estimates there are about 12,000 individual sunscreen SKUs if you count different sizes and packaging. Depending on when – or if – the FDA requires new SPF testing or different labeling, all of these will need relabeling and also new testing. Some will need to be reformulated if they are to stay on the market. The cost to the industry, not to mention to each brand, could be stupendous – and could be one of the reasons inaction has been the only action.
Active ingredients allowed by the FDA for sunscreen
Listed alphabetically by common names, the so-called “actives” on this list are only the individual ingredients. Combinations approved separately are not included. Although there are only 17 actives allowed, the FDA estimates there are more than 2,800 over-the-counter sunscreen products of different formulations, not to mention the estimated 12,000 individual SKUs.
Ingredients will be found listed using a so-called “Drug Facts” label” (see example to the right) on many brands, although since it isn’t officially required yet, some may not use it.
Basically, these sunscreen active ingredients in these thousands of products affect the structure and function of the body by absorbing, reflecting, or scattering the harmful rays of the sun to alter the normal physiological response to UV radiation. The current list of 17 is:
Ecamsule (Mexoryl SX) – added in 2006 and only for use by L’Oreal
PABA (p-Aminobenzoic acid)
Padimate O (OD-PABA)
Trolamine salicylate (Triethanolamine salicylate)
Tinosorb is an ingredient approved for use in other countries but not in the United States It is one that some manufacturers yearn for, noting it is a very effective broad-spectrum sunscreen.
Australian Sunsmart campaign -- Australia has the highest rate of skin cancer in the world due to its fair-skinned residents and the latitude – two of three Australians will develop skin cancer during their lifetime. With a rate that high, the government began this public campaign three decades ago with the motto, “Slip! Slop! Slap!” (slip on sun-protective clothing, slop on sunscreen, slap on a hat).
Environmental Working Group – A non-profit advocacy group that is often criticized for its sensational claims and proclamations while also being lauded for the way it pushes the agenda of protection and oversight. Its fourth report on sunscreen was issued May 24, 2010, and immediately gained critics and proponents. However, it did drive many national news agendas to look at the topic of sunscreen. (Its 2009 summary of findings can be accessed here, where you will also find links to other topics.)
EWG Cosmetics Database – The Environmental Working Group runs a searchable consumer database with its recommendations for good and not-so-good sunscreens, which again is oft-criticized since it doesn’t do its own testing and won’t reveal the exact details of how it analyzes each product. Some manufacturers want to be on the EWG list (any publicity is good, they say), while others are quite pleased not to be on the list. This can be one additional reference but should not be the end-all, be-all for information and buying decisions.
Food and Drug Administration rulemaking history for OTC sunscreen drug products
FDA “final” 1999 monograph on avobenzone
Melanoma/Skin Cancer Detection and Prevention Month (May), sponsored by the American Academy of Dermatology. Here, you can take the Academy’s “Suntelligence” survey, as well as find out how to perform a skin self-exam. You can also download a body mole map and find free skin cancer screenings in your area.
National Cancer Institute of the federal National Institutes of Health
Personal Care Products Council, a trade association and lobbying group representing cosmetics manufacturers, runs several resources: A database called Cosmetics Info discusses ingredients and testing, often with quite a different slant than the Environmental Working Group. It also funds something called the Cosmetic Ingredient Review with the support of the FDA. The website states it is run independently.
Important: When reading any report or website, look for who is funding the group, where it makes any additional money, whom it represents, what its political agenda could be and who it works for or with. Some of the above groups may have particular agendas or biases, so reading many information sources and using your own high filter to analyze the information and accept selectively.
This article summarizes additional information as a part of an exclusive, three-part SNEWS investigation into the world of sunscreens that began May 26, 2010, and continued May 28 and May 31. Stay tuned for additional stories on other trends in sun-protection, as well as news as it happens coming from the FDA, manufacturers and others involved in sunscreen and your health. We look forward to hearing from you with any questions or comments.