The FDA's New Sunscreen Ruling: What Does It Mean?

You may have heard that the FDA has come out with new sunscreen guidelines today. While the changes won't "really" take effect until June 2012, chances are that products with the new labels will start popping up at stores near you in the next 4-6 months.

Read on to learn more about how things are labelled this summer and how that will be changing next year.

I've previously covered what sunscreens are and how do they work as well as how to pick the right sunscreen for you. Pop on over and read both of those posts if you aren't familiar with them, I won't be repeating all of the info in them here.

Basically, SPF currently stands for Sun Protection Factor (the FDA actually admitted today that they toyed with the idea of changing it to Sunburn Protection Factor but decided against this). SPF is multiplied by how long your skin usually takes to burn and how long it will burn instead based on the protection offered by that sunscreen.

• SPF 15 blocks 93% of all incoming UVB rays
• SPF 30 blocks 97% of all incoming UVB rays
• SPF 50 blocks 99% of all incoming UVB rays

Yes, that's right. Currently SPF only refers to UVB radiation protection. To protect yourself from UVA radiation you relied on a company using the term "Broad Spectrum" on the label, which was not regulated. One company's broad spectrum didn't equal another company's broad spectrum, since some companies put it only on product that cover short and long wave UVA rays, sometimes only short wave UVA needs to be prevented and I swear I have found it on products that only protect against UVB radiation. What's broad spectrum in that??

So, US consumers had no way to know how much UVA radiation protection (if any at all) was offered in a product. You may have seen designations such as PA++ on products, but what does this mean and why isn't it on everything? It is a European designation for UVA protection, but it doesn't appear on everything in the US. Because it's... well, meant for Europe. The FDA proposed a 4 star system back in 2007, but nothing had been finalized. Frankly, to me 4 stars seems more appropriate for picking a hotel when I go on vacation, not my sunscreen.

To help readers (and mostly, myself) know if a sunscreen has any UVA protection, I've been posting the UV range at the bottom of posts for products that contain sunscreen. So, you can see if there is any short or long wave UVA protection in that product. Unfortunately, I can only tell if the ingredients are there, not how much protection they provide (I'm not cool like Coppertone or Aveeno, I have no at-home sun protection testing capabilities).

More confusion: Water resistant, Very Water Resistant, Waterproof and even Sweatproof. They all appear on sunscreens in the US, despite the FDA saying the "proof" versions shouldn't be there. And what is the difference between water resistant and very water resistant anyways? (There is a difference, it's in this post, what makes a sunscreen waterproof.)


New Changes in 2012
So, there are new changes to come, and I'm happy about most of it. Overall, sunscreen labels will provide more information and be easy to read. Score!


SPF
The new SPF will still refer primarily to UVB coverage, though it will sometimes also reflect UVA coverage (see below, broad spectrum, for more info on this). The major difference is that you will no longer see SPF products over 50 on the shelves. Instead they will be labelled 50+. So, those 85, 90 and even 100 products are going bye-bye.

The FDA's reasoning (and it is correct) is that since SPF 50 already blocks 99% of incoming UVB radiation, studies have found no advantage to using over SPF 50.

My issue is this: Most people don't use the correct amount of sunscreen. Remember the other day, I told you everyone over at The Pulse Network was shocked when I revealed that the average adult should use 1 ounce (a shot glass) worth of sunscreen? And that your tube is really more like 1 day at the beach, not an entire summer's worth? Higher SPF sunscreens provide a little more buffer for inadequate sunscreen application. Poor application of a SPF 15 might really give you SPF 8, but poor application of SPF 85 likely puts you over SPF 30.

My second issue: Those of us that are very fair, have a personal or family history of skin cancer, or spend a lot of time outdoors should be using higher SPF value sunscreens. Limiting us to SPF 50 kinda sucks.

I do concede that if you have used your sunscreen appropriately then SPF 50 is likely fine for pretty much everyone.


Broad Spectrum
Remember all of my ranting about the term "broad spectrum" a few paragraphs ago? How it seems to mean something different for most companies? Well, that is a thing of the past.

New rules: SPF will reflect UVB coverage. However, it may also reflect UVA coverage if labelled as "Broad Spectrum". Basically, the FDA has set it up so SPF is tested to determine the overall UVB coverage number just as before. Then, they test again at 370 nm (in the UVA 1 range). If the coverage passes a certain set point, then the product can be labelled as "Broad Spectrum". This is a pass/fail test, not an overall percentage. So, if the product is just under the expected set point then it can not be labelled as Broad Spectrum. The best part of this is that the UVA coverage test point changes as the overall SPF changes. So, if you buy an SPF 15 product there is an expected amount of UVA coverage, but the UVA coverage in a SPF 30 product is higher as is the SPF 50+ product.



As you can see from my UV range chart, the new broad spectrum labeling ensures that there will be one of three ingredients in the product: Avobenzone, Ecamsule or Zinc Oxide. My only concern now is that there won't be UVAII coverage in all products, as you can see it would be possible to formulate a product to have UVB coverage (giving the SPF number) and then adequate coverage in the UVAI range to get the broad spectrum designation without having any coverage in the UVAII range. Because of this I'll continue to post my UV range charts on sunscreen posts after the changes go into effect next year.


Waterproofing
In theory (?) the terms waterproof and sweatproof weren't allowed on bottles anymore. Today the FDA even said, "Waterproof wasn't really allowed, even though we saw this, as well as Sweatproof." But, you can easily find these terms on some of my favorite sunscreens. I'm hoping that the new rules get rid of these terms completely on bottles, because I have no idea how they were still around.

First, it helps to know about the method of testing water resistance in sunscreens. Human volunteers apply the product to areas of skin that aren't sun exposed for testing (basically, I think that means their butt?), they swim in an indoor pool for 20 minutes and then air dry. This is repeated multiple times. The SPF that the product tests at after the water exposure is what gets put on the label.

By the old rules, a water resistant product had a total of 40 minutes water exposure, very water resistant products underwent 80 minutes of water exposure. New rules will result in the "Water Resistant" label, but then there will be a time designation- 40 or 80 minutes. So, you know how the product has been tested and when to reapply!

So, I see only good things with this change.


Other Interesting Info

1. New Sunscreens
The FDA said in today's statement that there are other active ingredients that merit investigation into possible approval. This is great news as the US typically lags behind other countries in sunscreen technology. Bemotrizinol (Tinosorb S), bisoctrizole (Tinosorb M), and octyl triazone were all mentioned by name. The Tinosorbs are known to be very photostable. Unfortunately, no timeline for their investigation or possible approval was mentioned.



2. Expiration Dates
You may have noticed that while a 1 year expiration time is usually mentioned for sunscreens, products aren't labelled to reflect this. The FDA says:

Currently, regulations in 21 CFR 211.137(h) do not require that an expiration date be included in labeling if an OTC drug product does not have any dosage limitations and is stable for at least 3 years. This regulation applies to many OTC drug products, including sunscreen products. Any modification of the existing regulations would require publication of a proposed rule addressing all OTC drug products affected by the expiration date regulations.

So, they won't require them because it would mean changing a regulation that applies to over the counter medications in addition to sunscreens. Note that while they say it is stable for "at least 3 years", this typically refers to unopened product. You should still throw away your sunscreen if it has been open for a year.



FDA Press Release
FDA: Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use