We at SNEWS® have heard the warnings about too much sun exposure and the risk of cancer so you’ll find bottles, tubes and sticks of sun-protection concoctions all over at the home and office -- in the car, at the front door, on the deck, in the office, in workout bags, and on the bathroom vanity. But what we found in our exclusive, in-depth, three-part investigation that kicked off May 26 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. Meanwhile, we are all left in danger. Forget the minor risk of early skin aging and wrinkles. We mean the risk of deadly melanoma cancer.
So we started to dig around in mounds of FDA documents, court papers and scientific research to find out how this was possible and what it means to consumers and retailers alike. In the first of three parts published on May 26, we explained the basic chronology and history of the FDA inaction, the development and meaning of the Sun Protection Factor, and the danger and differences of ultra-violet radiation such as UVA and UVB. We weren’t the only ones in shock at what we found.
“I’ve been duped,” admitted Mark Masthay, Ph.D., chair of the chemistry department at the University of Dayton, Ohio, and a photochemist who has published research on the effects of UV light. Although an expert on UV light and its dangers, when SNEWS explained to him some of the details of packaging claims and various ingredients, he was stunned to hear labels are mostly a free-for-all.
In this article, part two of three, we’ll explain what the fine print on containers means – and doesn’t – and lay out details about some of the active ingredients allowed for use in the United States. In the final article, to run May 31, of our exclusive three-part series, we’ll pull together answers to a lot of questions about claims, marketing, misconceptions and ingredients, and offer tips to help retailers (or even users) make better buying decisions. In a special secondary story, also on May 31, we'll give a list of resources you can turn to for furthering your education and summarize the FDA status.
Reading the fine print
But, wait, you think, I read the labels and I fish out my glasses so I can read the claims in teeny tiny type on the back, yet you’re telling me my skin is a ticking time bomb and I can’t believe what I read? In many cases, the manufacturers – thanks in part to the FDA’s lack of action for 32 years – have their fingers crossed behind their backs when they print certain claims on packaging. Sometimes they may just be little white lies, just pushing the edges of what would be considered the truth. Sometimes they are using semantics to prey on a health desire or ethical belief, such as not wanting to harm reefs or wanting to avoid chemicals. Sometimes they may be using the gray area created by the FDA inaction to dance a fast jig. And sometimes they could actually be outright lies.
Take the term “broad spectrum,” for example. This is a claim we have been told to look for when buying sunscreen. See it on a label and you can be assured it will protect you from both the cancer-causing UVA rays and the burning UVB rays…. Right? Uh, maybe.
There is no definition for what must be in a sunscreen called broad spectrum – how much of what ingredient or even which ingredient it needs to have to satisfy the label of broad spectrum. Even sunscreens that include ingredients with relatively insignificant UVA protection can slap on the broad-spectrum label. Plus, labels do not point out that certain ingredients can degrade to a point where they soon don’t offer protection at all.
“It’s very misleading,” said Sancy Leachman, director of the melanoma and cutaneous oncology program at Huntsman Cancer Institute in Salt Lake City, Utah.
Basically, only a few ingredients actually offer truly effective low-risk “broad-spectrum” protection, meaning they not only keep you from burning but also include protection from the deeper danger caused by exposure to UVA rays. Those active ingredients are zinc oxide, titanium dioxide and avobenzone, with a few proprietary blends, brand names and formulations such as Parsol 1789, Mexoryl, ecamsule and Helioplex. Zinc, titanium and avobenzone are three of the 17 active ingredients for sunscreen allowed by the FDA for use by all brands and are the ones you will more commonly see on a list of ingredients, while the others are either brand names or proprietary. Remember, though, if a product with any of these active ingredients claims sun protection, it is considered a drug and falls under FDA oversight. But -- here’s the kicker -- if a product has any of these active ingredients but does not claim sun protection (such as a so-called poison ivy block that SNEWS recently came across), it is considered a cosmetic and does not fall under the auspices of the FDA. And just having one of these doesn’t guarantee broad-spectrum protection.
“There are a lot of misleading statements,” said David Andrews, senior scientist at the Environmental Working Group, a watchdog advocacy group that has hundreds of pages of analysis, rankings and definitions on its website (www.ewg.org). The EWG’s methodology is questioned by some who call it “pseudo-science” or “bogus,” but nobody argues that the group doesn’t have the public’s best interests in mind, with Beyond Coastal's John Bercaw noting, "Their heart's in the right place."
“I applaud the effort the EWG has made, but unfortunately, it is making too many assumptions in its methodology,” said Steven Johnson, president of manufacturer Sol Sunguard sunscreen. “And some of the sunscreens they list as their ‘Best Sunscreens’ would never be able to adequately protect in a very active environment.”
Despite offering broad-spectrum protection and characteristics often more applicable to an active person, each of the three commonly allowed “actives” -- zinc oxide, titanium dioxide and avobenzone -- has its own issues:
>> The maximum allowed by the FDA for both zinc oxide and titanium dioxide is 25 percent, but you’ll never see that in an over-the-counter sunscreen. Put on a 25-percent potion and you’ll look like Frosty the Snowman. So for manufacturers it turns into a dance to figure out how to cut it, manufacture it, mix it, thin it or encapsulate it to not lose too much protection while avoiding the white-skinned look. Plus, both of these are more expensive. So you may even in good brands see only about 3 percent to 10 percent, which usually will do the job.
Knowing vanity is so important to many consumers, manufacturers are now playing with nano-particles, a relatively new frontier in the sunscreen industry and information that is not currently revealed on labels. In an attempt to make the snowman face go away so people will wear sunscreen, let alone put on enough, manufacturers are playing with putting the particles in the shrink machine. If you make the zinc and titanium particles nano-sized, they should offer the same protection but the smaller they get, the more translucent they will be. The problem is, nobody really knows at what point the chemicals will get so small they may seep through your skin and into your blood stream or what risks that could cause.
>> Avobenzone, with a maximum allowed by the FDA of 3 percent, is a much more common UVA broad-spectrum ingredient; however, the chemical used by itself is quite “photo-instable,” meaning if it is exposed to sunlight (yes, even when on your skin), it very quickly loses its efficacy, i.e., if it’s on your dashboard or on the deck in the sun, it likely won’t be worth more than a moisturizer, if that, in a few days or weeks. To counter the instability, some brands mix avobenzone with another active ingredient that helps stabilize it, such as octocrylene. Some brands have come up with their own chemical options to substitute, for example Mexoryl. L’Oreal has a proprietary recipe for Mexoryl (Mexoryl SX) that is called, among other things, ecamsule, that was approved as a drug by the FDA in 2006, but is only available for use by L’Oreal for a number of years. Neutrogena also has a proprietary blend called Helioplex, but you will only see avobenzone or ecamsule listed on the label.
So how do you really know if you are doing more than just staving off a burn while still soaking in all those cancer-causing rays? Make sure the sunscreen has one of these three commonly available ingredients listed on its label (zinc oxide, titanium dioxide or avobenzone) or one of the proprietary ingredients, and that the label says what percentage it includes. Said Johnson of Sol Sunguard, “If it doesn’t tell you, don’t buy it.” Also, choose a higher percentage of that one ingredient if possible as a way to hedge your bets, for example, choose 5 percent zinc oxide instead of 2 percent. Then, however, all you can do is cross your fingers.
Part of the FDA monograph – the document that hasn’t been approved or finalized – includes a rating system using one to four stars that would rank cancer-risk-inducing UVA just as SPF is said to rank burn-producing UVB, as well as a rating system using words to better clarify chance of burning.
“To prevent consumer confusion about UV radiation protection, FDA is proposing changes to UVB radiation protection labeling (i.e., the SPF value),” the August 2007 FDA monograph stated. “To further improve consumers understanding of the sunburn protection level provided by a certain sunscreen product, FDA is proposing to require descriptive terms of relative sunburn protection (i.e., ‘low,’ ‘medium,’ ‘high,’ and ‘highest’).”
The FDA goes on to explain how a product with medium UVA protection against cancer might have two (of a possible four) stars on the label shown in solid black, with the remaining two in white, to indicate it has a two-star or medium protection rating. The label could then say “UVA ** Medium.” That could be positioned next to the UVB burn rating that could state, for example, “SPF 30 High,” since 30 is considered high protection. The goal is to make the packaging, claims, ingredients and protection more transparent, understandable at a glance – and not require a chemistry degree or magnifying glass. (See examples, right, of what that could look like.)
Although that sounds sensible, even the federal National Cancer Institute, part of the National Institutes of Health, indicates the FDA, its sister organization, hasn’t been doing its job. The National Cancer Institute (www.cancer.gov) wrote in a 2009/2010 sun protection update: “The Food and Drug Administration has pending regulation to improve labeling on sunscreen about UVA and UVB because current labeling misleads the public about the protection they are getting from the sun.”
“We don’t want to shoot in the dark,” said David Kulow, president of manufacturer All Terrain, who like other manufacturers wants to see some standards. “It’s a gray area right now. You want to know what the playing field is going forward.”
Bottom line: All that you can count on and trust due to the lack of federal oversight is the Sun Protection Factor and the use of allowed active ingredients. In other words, caveat emptor. Let the buyer beware – be it consumer or retailer.
(More detail about other common claims, including “waterproof,” “natural,” “fragrance-free,” “oil-free” and “dermatologist-approved” will run in Part 3 of our investigative series, to be published on May 31.)
Leveling the field
Manufacturers of specialty sports sunscreen brands with whom SNEWS spoke told us that’s what they really want in the end – a level playing field. They are tired of playing games, tired of having to compete with the unethical types, tired of knowing some are treating the Wild Wild West as a way to do whatever they please and fudge here and there.
Some trusting souls tell us that, of course, all the manufactures, both mass-market and specialty, are following the proposed FDA rules, even though they aren’t final. But some manufacturers have told us they know for a fact that’s not the case.
“To some degree, it is lawless because some companies just put a product on the market without doing all the testing because nobody is policing it,” said Jeff Kletter, co-founder of Kinesys sun protection sprays and other suncare products.
Kletter maintained “you get what you pay for” and to some extent most won’t argue – particularly if you are looking for protection for an active, athletic, water-oriented, sweaty or long-lasting endeavor, such as mountain biking, paddling, backpacking, running a marathon or doing an Ironman.
Nic Martens of Scape brand, the photochemist who used to work with Neutrogena while he was at Johnson & Johnson, said there isn’t necessarily something wrong with all of the cheaper, drug-store brands. In fact, an active person could get away with spending less money on one bottle to use for standing around the BBQ or taking the dog for a short stroll. But as soon as you add the challenges of high sweat production, water splashing, friction from clothes or equipment, the need for lasting through many hours of activity or avoiding stinging chemicals running into eyes, the active person better reach for the high-end brand to be sure it’ll continue to give protection through the beating he or she is giving it.
To level the field and eliminate unethical, untrue claims, a class-action lawsuit was filed in 2006 in the Los Angeles Superior Court to address what it called false advertising and deceptive promotion. The blazing courtroom gunfight garnered a plethora of high-profile press in the weeks after it was filed. But when SNEWS went searching for the case’s status this spring, nobody seemed to know anything about it and there hadn't been a peep in news reports or blogs since 2006 when the principal lawyer called sunscreen “the snake oil of the 21st Century” – over and over and over again. And, he usually added, “The companies that market it are Fortune 500 snake oil salesmen.”
To find out what happened, we went to the law firm itself, Lerach Coughlin Stoia Geller Rudman & Robbins, a high-profile New York firm itself known for its class-action filings, such as the one brought against Enron Corp. for its accounting practices. The sunscreen case was originally filed against the five largest manufacturers -- defendants and their key brands then were Schering-Plough (Coppertone), Johnson & Johnson (Neutrogena), Playtex Products (Banana Boat), Tanning Research Labs (Hawaiian Tropic), and Chattem (BullFrog). In October 2008, the case was settled “with prejudice,” meaning a case with the same claim could not be brought again and the one-page settlement stated it had been “amicably adjusted by and between the parties.” Speculation is that sales and mergers of the companies and brands prompted some kind of confidential cash settlement. (Schering-Plough merged with Merck. Playtex was bought by J&J, and then sold to Hanesbrands. Chattem was bought by the French company Sanofi-aventis.)
Soon after the case's 2006 filing, Connecticut Attorney General, Richard Blumenthal, wrote a scathing letter calling FDA standards “outdated,” “inadequate” and responsible for giving consumers a false sense of security, while allowing manufacturers to make “dubious and deceptive claims.” He pushed the FDA to face “a spreading epidemic of skin cancer” and called for action. Soon after, a few legislators stepped up with the so-called SUN Act (SB 1112) being introduced by Sen. Christopher Dodd, D-Conn., in 2008 and again in 2009 that demanded FDA action. That bill is still in commitee, Dodd's office said, and he is expected to issue another demand for FDA action soon. Again, Blumenthal took the FDA to task: “Faced with mindless inertia by our FDA, this federal legislative action is vital to immediately stop sunscreen manufacturers from making dangerously misleading claims about their products.”
That wasn’t the last of the lawsuits and legal maneuvering, but so far nothing real has materialized. Some claim the continued inaction is because big money is at stake, stalling the FDA in a political quagmire. For example, in April 2009, Schering-Plough sued Neutrogena for spreading false and misleading statements in product comparisons and in statements about the protective ability of its sunscreen. The case was settled in April 2010, but not without the court basically slapping both companies.
These ads, the court wrote, are “essentially meaningless and, therefore, of no help to the consuming public who, finally, is paying attention to the health concerns presented by overexposure to the sun.”
The consumer – duped, confused and at risk -- remains the real loser as the sunscreen wars wage on.
In our story’s last of three parts to run May 31 in SNEWS, our exclusive, in-depth investigation of the world of sunscreen will pull together answers to common questions about marketing claims and misconceptions, and give a key list of tips to help anyone heed the warning "caveat emptor" -- retail buyer or user. In a special secondary story, also on May 31, we'll give resources to check out ,including FDA-allowed ingredient lists and links to other associations, databases and FDA documents to further your education.