On December 17th, 2012 the new FDA sunscreen rules will take effect. Here is what you need to know:
Why the FDA created new rules for sunscreen:
There is actually a lot of research out there on sunscreen and ultraviolet light. Not only has it been proven that ultraviolet light causes all of the major forms of skin cancer, but also we now know a lot about how different patterns of light exposure cause different types of skin cancer. We also know a lot about what works well as a sunscreen and how best to build them. In addition, we know that in the real world, protection from ultraviolet light with sunscreen leads to a reduction in skin cancers.
The problems is that the consumer market for sunscreens is like the Wild West. There are thousands of products out there, many of which make all kinds of claims, but don’t necessarily do what they say they do. After decades of letting manufacturers say almost anything, the FDA has finally used its regulatory authority to limit manufacturer’s ability to make claims that can’t be backed up. The FDA has also tried to create some standards that will make choosing sunscreen simpler. By eliminating bogus claims and making it easier for consumers to choose, it is hoped that consumers will be more likely to use the biggest tool they have in their own personal anti-cancer efforts.
Major changes in Sunscreen Labeling:
Elimination of separate labeling for UVA and UVB
Many consumers realized that blocking UVA was important and started looking for sunscreens that block UVA as well as UVB. The problem is that it has been pretty much impossible to know how well a sunscreen blocked UVA. Did it block it just a little bit or was it actually really good? The reason it is hard to tell is because the SPF number provides a good measurement of UVB blocking, but not UVA blocking. There hasn’t been an agreed upon measure of UVA protection, so manufacturers were allowed to label their sunscreen as providing UVA coverage as long as they added any amount of a UVA blocking agent.
So, the FDA decided to simplify this by creating something called the critical wavelength test that measures UVA protection that allows them to hold manufacturers accountable to how well they block UVA. Its a very technical measurement, but the good news is that you don’t need to know anything about it! Initially, it was thought that UVA protection was going to be listed with a 1-4+ rating scale. So you would have had to look at SPF as a measure of UVB protection and some 1-4 scale of UVA blocking. However, we’ve now found out that its actually pretty important that UVA and UVB protection be in balance -so SPF85 with UVA 1+ protection would not be a good thing. So the FDA decided to eliminate the UVA rating system and instead require that UVA coverage be in the right balance with UVB coverage for a company to be able to use a new “broad spectrum” label. Easy.
The new “Broad Spectrum” label
The new “broad spectrum” label will only be allowed on sunscreens that can actually reduce skin cancer because they are built the right way. First, they must keep UVA and UVB coverage in proportion as discussed above. Second, the label can only be put on sunscreen with an SPF of 15 or greater since lower strength sunscreens aren’t strong enough to reduce the risk of skin cancers.
What this means is that as long as you pick a sunscreen that is labeled “broad spectrum” you don’t need to think about whether it has the proper balance of UVA/UVB protection. Next, even though the SPF number only measures UVB protection, the proportion of UVA coverage must always be maintained in the new labeling system, so the SPF number now gives you a good measure of overall effectiveness.
Water Resistant Sunscreen?
Manurfacturers no longer will be allowed to use the terms waterproof, sweatproof, or sunblock. There never were any formal definitions for these terms that would allow these claims to be tested, so you were literally taking their word for these claims.
Now, the FDA has developed standard testing for the effectiveness of sunscreen after 40 or 80 minutes of swimming or sweating. Sunscreens must now tell you whether they are Water Resistant for 40 minutes or Water Resistant for 80 minutes. If they fail the water resistance test, they must include a warning to use a water resistant sunscreen if swimming or sweating.
Claims that sunscreen will make you younger, prevent wrinkles, or prevent cancer
Under the new rules, only broad-spectrum sunscreens with an SPF value of 15 or higher can claim to reduce the risk of skin cancer and prevent skin aging. Non-broad spectrum sunscreens and broad spectrum sunscreens with SPF value between 2 and 14 can only claim to prevent sunburn, but must carry a warning that they haven’t been shown to help prevent skin cancer or early skin aging.
Who the new sunscreen rules apply to:
- Companies that sell less than $25,000 of product are exempt for another year
- Product shipped before December 17th with the old labeling can still be sold
How to tell if sunscreen is using the new requirements?
The label must include the statement “Broad Spectrum SPF (number)”
It cannot make any reference to UVA.
The entire text must be in the same font and same color and can’t be broken up with graphics or logos.
Older labels might still include the term “UVA/UVB protection” or show the words “broad spectrum” in a different location or font from the SPF number.
So what sunscreen should I buy?
Look for new labels that say “Broad Spectrum SPF 30” or higher. Look for water resistance of 80 minutes if you are going to be in the water or get sweaty. The American Academy of Dermatology recommends choosing at least a 30. Personally, I use 50 because I burn very easily.
Anything that meets this requirement is going to give you good protection if you use it the right way:
- Use 1 oz of cream to cover your body (a shot glass worth)
- Reapply every 2 hours
- Reapply when you get out of the pool
After that, it’s a matter of preference. You can read more about my sunscreen recommendations here.
What is coming in the future?
- More zinc and titanium oxide. These inert physical blockers make great sunscreens but have a bad reputation for looking like thick white paint. This is related to the particle size of the mineral particles. New micronized formulations are not as visible. This is causing them to be much more widely used. There has been some concern about “nano-particle” sunscreens being absorbed into the skin, but this hasn’t been found to actually happen, nor is it even necessary to use “nano-particles”.
- Limits to SPF numbers. The FDA is interested in whether higher SPF matters and has asked companies to submit data. The question here is whether SPF150 really offers much that SPF50 does not. In most other parts of the world, SPF50 is the highest it goes. The reason is because the relationship between SPF number and UV blocking effect is not linear, meaning that SPF 50 is not twice as good as SPF25. SPF 8 blocks 87.5% of ultraviolet light, SPF 15 blocks 93.3%, SPF 30 blocks 96.67% and SPF 60 blocks 98.33%. You can see that once you hit SPF30, only 3.33% of ultraviolet light is making it through, but the returns are diminishing as you keep going higher. Once you are in the recommended range of SPF30+, its easy to see that reapplying it often enough is likely to be more important than going for a higher number.
- A wider variety of ultraviolet blocking chemicals. Currently there are about 20 different ultraviolet filtering ingredients approved in the US compared to about 30 in Europe and about 40 in Japan. Several of these are being considered for use in the US because of their long safety record overseas.
- Substantivity. This refers to how long sunscreen lasts. One major area of consumer confusion is how often to reapply sunscreen. The answer isn’t simple thought because it depends on what the sunscreen is made of. The FDA is being pushed to come up with methods to measure this so that specific recommendation can be included on labels.