The FDA’s New Sunscreen Guidelines: Will They Really Help?

July 22, 2012 by Leave a Comment

Whether you’re headed to the beach or just playing in the sun, you should always use some form of sun protection such as protective clothing or sunscreen. But the way you shop for sunscreen is changing; the Food and Drug Administration has rolled out new guidelines for the labels you find on sunscreens. While sunscreen manufacturers have until the winter to comply with these guidelines, some have already begun to offer products with new labels.

The new labeling is intended to make it easier for consumers to choose the right sunscreen by creating standards for sunscreen labels as well as encourage manufacturers to move in the direction of making more Broad Spectrum products. Under the new guidelines:

  • Only products that protect against both types of UV radiation (UVA and UVB) and have an SPF 15 or higher can be labeled as “Broad Spectrum” sunscreen. Broad spectrum products offer the best protection from UVB-induced sunburn as well as premature aging and skin cancer believed to be caused by UVA exposure.
  • Products that claim to be “water resistant” must clearly indicate on the front of the bottle how long a user can expect to receive the declared SPF level of protection while sweating or swimming. Only one of two times are permitted on the labels: either 40 or 80 minutes.
  • Manufacturers can no longer make claims that their sunscreens are “sweatproof” or “waterproof,” nor can they identify their products as “sunblocks.” They also cannot claim that their products offer “instant protection” or protection for more than two hours without being re-applied.

 

Click to view the FDA's video on new sunscreen regulations

 

You can learn more about UVA and UVB radiation here.

You can find the full FDA guidelines and more here .

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What We Still Don’t Know About Sunscreens: A Running Debate

August 12, 2010 by Leave a Comment

As I mentioned in my last post, about the only thing that seems to have changed with respect to the state of sunscreens and sun safety products is that the mainstream media is starting to pay more attention to this issue and take a frank look at what needs to be done.

The New York Times appears to have taken the lead here with its recent Room for Debate blog: What We Still Don’t Know About Sunscreens. In Room for Debate, The Times invites knowledgeable outside contributors to discuss news events and other timely issues. For this conversation, the Times convened the following contributors:

  • Darrell S. Rigel, Clinical Professor of Dermatology
  • Sonya Lunder, Environmental Working Group
  • Michael K. Hansen, Consumers Union
  • Kerry Hanson, Chemist, University of California, Riverside
  • Lenora Felderman, Dermatologist

Darrell Rigel tackles the subject of better labeling and better ingredients. Apparently in the U.S. there are only 17 approved sunscreen agents, while Europe has 28, and Japan has more than 40. He blames the FDA for lagging in formally approving regulations and feels that rather than wait until they can come up with their own standards for testing UVA that we simply adopt the same standards as Europe has.

Sonya Lunder looks at an alarming new finding: the use of Vitamin A (in the synthetic form of Retinyl Palmitate) in sun care products may be accelerating the development of skin lesions and tumors when applied in the presence of sunlight! According to Lunder, this ingredient can be found in a whopping 40% (almost half!) of sunscreens used in the U.S.

Michael Hansen takes the FDA to task for not being more aggressive in demanding and enforcing the use of warnings on product labels that would clarify which products provide actual protect against UVA. A product may have a high SPF which means it protects against UVB radiation but that doesn’t mean it protects against UVA. He also feels that the FDA should more thoroughly investigate the health concerns that have been raised about various sunscreen ingredients.

Kerry Hanson questions whether our current concept of sun care protection needs to be redefined given what we’ve learned about the difference between UVB and UVA exposures and their respective roles in causing or promoting skin cancer. Since companies don’t have the substantial resources needed to fund the research (or the proper impartiality), there’s an opportunity for government agencies like the FDA, National Science Foundation, and the NIH to jump in and take the lead.

Lenora Felderman laments the false sense of security that sunscreens provide and echoes the other contributors’ call for better and more responsible action by the FDA.

Since it was posted on July 5th, this has generated over 200 comments. You can read the full discussions here and add your comments as well.

What do you think the FDA’s top priorities in this area should be?

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Update on the State of Sunscreens: The More Things Change, The More They Stay The Same!

August 10, 2010 by Leave a Comment

Every year around this time of the year, I scan industry trade rags and do some searching on the Internet in an attempt to find out what’s new in the market for sunscreens. And every year I marvel at how some things never seem to change! In fact they appear to be getting worse!

In spite of a growing body of increasingly credible evidence that turns everything we’ve been led to believe about sunscreens over the years on its head, companies are still producing essentially the same products, and packaging and marketing them in increasingly deceptive ways. Caveat emptor (buyer beware!) …

The FDA still hasn’t formally issued its new rules and guidelines for sunscreens with respect to UVA testing and labeling, which were informally adopted back in 2007 after an exhaustive 9-year review. This was supposed to happen in May and now the word is that it will happen later this year, probably in October. And in spite of the fact that there’s no consensus on whether sunscreens prevent skin cancer, and the discovery that some sunscreen ingredients might actually increase our risk of getting melanoma (the deadliest form of skin cancer), women’s magazines, sun product manufacturers, and dermatologists still relentlessly and religiously repeat the mantra to wear sunscreen whenever we go outside, or avoid any exposure to the sun. Are they really that blind to their hypocrisy or are they waiting for a larger force (i.e. the FDA) to force them to sit up and fly straight?

Most experts agree that people should use sunscreens to protect their skin from the sun, but they disagree widely on how well they actually work. There’s so much conflicting information and outright disinformation on the subject how can anyone make a reasonable decision about what products to use? The simple fact is that sunscreens were never developed to prevent skin cancer. They were (and continue to be) designed primarily to prevent sunburn. And even though SPF ratings are notoriously unreliable people continue to mistakenly believe that using higher SPFs buys them a lot more time in the sun without risk, so sun care companies keep coming out with higher and higher SPFs. We’ve hit a new high (or new low depending on how you look at it) with SPF 100!

Almost in defiance of the FDA’s proposed regulation, these companies substantially increased their high-SPF offerings this year. According to the Environmental Working Group’s analysis of nearly 500 beach and sport sunscreens, nearly one in six products now lists SPF values higher than 50, compared to only one in the prior eight years. Neutrogena has six products labeled “SPF 100,” and Banana Boat has four.

About the only thing I can see that has changed is that more mainstream media are finally starting to question the safety of sun care products.

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Skin Cancer & Sun Damage: What You Really Need to Know

August 24, 2009 by Leave a Comment

The prospect of getting skin cancer is frightening for anyone. If the prognoses of doctors, dermatologists, beauty magazines and the media in general are to be believed, everyone is at risk. And yet, there’s no hard scientific evidence that this is true. In fact, there’s a growing consensus in the medical community that the anti-sun rhetoric that’s had everyone slathering on sunscreen every time they step outside, has been over-stated.

It helps to know as much as you can to make an educated guess as to the best options for minimizing the risk for yourself and your loved ones. Here’s a summary of what I know now (and you should too):

  • Exposure to the sun without any form of protection leads to sunburn from UVB radiation. The more sunburns you get the greater your likelihood of developing skin cancer.
  • Sunburns and UVB radiation were considered to be the primary risk factor for skin cancer but now evidence suggests that UVA radiation plays a much bigger role in both skin cancer and premature aging.
  • Until recently, most sunscreens were developed to either physically block or chemically disperse UVB rays. Though many sun protection products have been reformulated to include some UVA protection the only ingredients that are known to be photo stable and effectively block out both types of UV rays are Titanium Dioxide and Zinc Oxide in the form of sun blocks.
  • UVB radiation is the way that our bodies utilize solar energy to convert it into vitamin D, which has been studied and found to be a key nutrient for keeping bones and teeth strong. A deficiency in vitamin D has been linked to other types of cancer including breast, prostate and colon cancers. Overuse of sunscreens blocks our bodies’ ability to synthesize this vital nutrient.
  • There is sufficient evidence to indicate that a variety of antioxidants that when taken both orally via diet & supplementation, and topically can significantly reduce the damaging effects of UV radiation.
  • There are three types of skin cancer: Basal Cell, Squamous Cell, and Melanoma. Basal Cell is the most common of skin cancers and it’s the most easily treated and least likely to spread. Squamous cell is also easily treated if detected early, but it’s slightly more apt to spread. Melanoma is the most serious form of skin cancer and the one responsible for the most skin cancer deaths because of how rapidly it spreads.
  • Basal Cell and Squamous Cell carcinomas typically appear on those parts of your body that are most often exposed to the sun –your face, ears, neck, lips, hands, arms, chest or back.
  • Melanoma most often appears on the trunk, head or neck of affected men. In women it most often develops on the arms or legs. In either gender it can appear in areas of the body that are never exposed to the sun.
  • Your skin type, as well as hereditary risk factors, along with poor nutrition and a weak immune system, play a greater role in your likelihood of developing skin cancer. People most at risk include those with freckles, fair skin tones, light colored eyes (green or blue), and naturally red or blonde hair. Others also at greater risk are those who burn easily, spend a lot of time outdoors, or have a personal or family history of skin cancer or melanoma.
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Understanding Sunscreens and the SPF Debate: Are You Getting the Protection You Need?

August 14, 2009 by 3 Comments

The alarming increase in skin cancer rates over the past 10 years has led to a proliferation of commercial sun protection products in the form of sunscreens and sun blocks designed primarily to protect you from overexposure to UVB rays –the ultraviolet blue rays that are known to cause sunburn and were long thought to be the cause of melanoma –the deadliest of all skin cancers.

The effectiveness of these products has been largely based on their Sun Protection Factor (SPF) ratings, which start as low as 4 and go as high as 50 or 65. Unfortunately, there is a lot of confusion about what these ratings mean and how effective they really are. This is due in part to a common misconception that if you double the SPF used, you will get double the protection or alternately, double the amount of time you can spend in the sun before you get sunburned. In fact, doubling your SPF results in only a small incremental increase in sunburn protection, and no SPF can give you 100% protection from UVB radiation.

Using higher SPF sunscreens tends to fool most people into thinking they can stay in the sun for longer periods of time and remain fully protected. This thinking overlooks a simple reality –the longer you stay in the sun the greater your exposure is to UVA rays which are now thought to play a much bigger role in causing skin cancer and premature aging. While you might enjoy some additional protection from sunburn with a higher SPF, the increase in exposure to UVA that comes from prolonged exposure may be putting you at a much higher risk.

So how do you know how much protection you’re getting and if it’s what you really need? Well it helps to understand a little bit about how SPF ratings are determined and what other factors come into play that can decrease their effectiveness.

The U.S. Food and Drug Administration defines SPF as the amount of time it takes to produce minimal redness (erythema) in skin via UVB exposure, which is visible 16-24 hours after exposure. This is also known as an individual’s Minimal Erythemal Dose (MED) and it’s achieved when the skin attains the amount of UVB required to produce sunburn.

Arriving at a Sun Protection Factor (SPF) rating involves exposing small areas of a test subject’s protected (MEDp) and unprotected (MEDu) skin to five to seven increasing doses of UV energy produced by an artificial light source called a solar simulator. Then a ratio is calculated by dividing the length of time a person can stay in the sun at noon with protection before burning by the length of time a person can stay in the sun at noon without protection before burning. The shorthand for this is SPF=MEDp/MEDu.

The final SPF value is determined by averaging the values obtained from a group of either 10- or 20- test subjects. These calculations don’t take into account the fact that MED will vary as a function of time of year, latitude, altitude, and of course, a person’s skin color and type. Nor do they include a calculation for protection against UVA radiation. Here’s a brief summary of what the different SPFs offer by way of protection:

  • As a simple example, an SPF 2 enables the skin to be exposed to UVB twice as long as when no sunscreen is used, before your MED occurs. This means that an SPF 2 absorbs 50% of UV rays, allowing the other 50% to get through, so it takes twice as long for the skin to absorb the amount of UV needed to produce redness.
  • An SPF 8 absorbs 87.5% of the rays leaving 12.5% to reach the skin. If you multiply 12.5% by 8, you get 100%, so the skin requires eight times the amount of UV needed to produce redness when wearing an SPF 8.
  • An SPF 15 absorbs 93.33%, allowing 6.67% to get through and an SPF 30 absorbs 96.67% allowing 3.3% to pass. SPF 30 does not offer twice the protection of an SPF 15. It offers less than 4% more protection.

It’s a challenge to arrive at the right number for SPF products due to various skin types, geography and mountain or ocean level effects. To complicate matters, the solar simulator used for SPF testing only vaguely resembles sunlight -throwing off too much short wavelength UVB and only half of the UVA in real sunlight. This can cause product SPFs to be so unreasonably high as to be almost meaningless, all other things considered.

And if you don’t know your MED then it’s difficult to know which SPF will work best for you. Unless you are fair skinned, have red hair, or must spend extended amounts of time in the sun, an SPF 15 should be adequate in most cases. A couple of other factors can help you make the most of your sunscreen:

1. Know Your Skin Type

Researchers have identified 6 different skin types and their relative risk for skin cancer. People with Type 1 skin have the highest risk of skin cancer and people with Type 6 skin, the lowest. Knowing your skin type can help you determine how high an SPF you need to be safe. You can read more about this in Michael F. Holick’s book The UV Advantage .

2. Know Your Risk of Exposure

The National Weather Service and the U.S. Environmental Protection Agency (EPA) teamed up and developed something called the UV Index, which provides a daily forecast of the expected risk of overexposure to the sun. The Index predicts UV intensity levels on a scale of 1 to 11+, where 1 indicates a low risk of overexposure and 11+ signifies an extreme risk. Calculated on a next-day basis for every zip code across the United States, the UV Index takes into account clouds and other local conditions that affect the amount of UV radiation reaching the ground in different parts of the country. You can find the current UV Index for your city at http://www.epa.gov/sunwise/uvindex.html.

Copyright 2009
Dropwise Essentials

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