Dr. Norman Levine: Finally would you discuss the proposed new regulations for sunscreen manufacturers and how they are going to impact us in dermatology?
Dr. Darrell S. Rigel: As you know, these regulations have been in flux since 1979, which is amazing that it would take that long for sunscreen labeling and regulations, and they are still not totally decided. I can speak to what is going on now, what has been changed, and some of the ways the sunscreen bottles are being labelled.
Basically the word broad-spectrum has meaning now. In the past, it was just a marketing term. So broad-spectrum applies to at least SPF 15, and it has a proportional level of UVA protection. SPF only measures UVB protection. Also, there is no such thing as waterproof anymore, there is water resistant 40 minutes or water resistant 80 minutes; again you have some idea of at least the water resistance in terms of the sunscreen.
What I think is so important with this is that you can now tell your patients you want them to use SPF 30 or higher, something that says broad spectrum, and something that says waterproof 80 minutes. So independent of product, at least you give people an idea of what to do.
What’s also happening that’s really important is that the new agents — those that are available in Europe which have not been available here in the United States, hopefully will now become available within the next year or so.
It doesn’t mean that the sunscreen agents we have in the United States are bad, but we’ll just have the ability to have more components to potentially make a better sunscreen. What I care about is that I want my patients to have the best sunscreen possible, and by having more components, theoretically, a better sunscreen can be made.
Whether there is going to be a cap on SPFs of 50+ or more is still up in the air. When the rules came out in 2011, they were going to make a decision, but they haven’t made the decision yet. I am personally opposed to a cap, because I think that it is little bit misleading. If it is a 50+, is it a 51 or is it a 100? In some places that will matter, but if you are a blonde or redhead in Southern Arizona, basically you might want to have something more than 50 to give you some extra protection. You won’t get that from the labelling.
Similarly the higher SPF sunscreens have an advantage because people under-apply sunscreen. Sunscreens are tested, as I mentioned earlier, at 2 mg/sq cm; nobody applies that density. So these higher SPF sunscreens, when used at real-world concentrations, are more forgiving. So if you have SPF 80, but you are applying ¼ of it, you are still getting a protection of 20. That’s the kind of thing that with a lower SPF, you just don’t get that additional window of protection or redundancy.
And finally if you put a cap on, there will be no incentive for people to make a better sunscreen, and they won’t get credit for it — that is a practical reason. But for all those reasons, I hope it’s not capped. It’s still up in the air, but about half the countries in the world do have a cap, so we will see what happens.