We Introduce The FDA’s Sunscreen Rules: Check The Facts Right – Part 1 

Sunscreens are used by many. No matter whether they are indoors or outdoors, sunscreens play a crucial role. Here we discuss some of them. 

We Introduce The FDA’s Sunscreen Rules: Check The Facts Right – Part 1 

image courtesy: Michael Pole / Getty Images

How Do You Decide On A Sunscreen? 

It will change the way we buy and use sunscreen as the FDA’s new sunscreen rules are over 30 years in the making. The fact that we are being encouraged to buy sunscreens that offer broad-spectrum protection is the biggest change. Hence it is not only protection from UVB radiation that the old SPF rating measured whereas from UVA radiation too. 

Other changes are also going to be made. Sending their questions are people through online as well as via Twitter and Facebook. It is possible that answers have the actual FDA rule. 

Experts include: 

Director of the FDA office of drug evaluation for the FDA Center for Drug Evaluation and Research (CDER), Charles Ganley, MD. 

Chair of dermatology at Detroit’s Henry Ford Hospital and chair of the science and research council of the American Academy of Dermatology (AAD), Henry Lim, MD, 

Interdisciplinary Scientist, Division of Nonprescription Regulation Development, Office of Drug Evaluation IV, CDER, FDA, Reynold Tan. 

The following are the answers from these members identified by their names. 

What are the new rules for sunscreen? When do they take effect?

Here are the most important ones for the new rules:

Although some sunscreen makers will launch their new labels before then, the new rules are set to take effect by summer 2012. Only on sunscreens tested for a minimum standard of UVA protection will the claim broad-spectrum appear. 

Even though all sunscreens will carry their SPF rating. SPF will rate only UVB protection on products without the broad-spectrum claim. Higher SPF numbers mean more protection against UVB as well as more protection against UVA on broad-spectrum sunscreens. 

Showing how long they last after a person has been swimming or sweating which is 40 minutes or 80 minutes are the sunscreens that claim to be water-resistant. In the fact box on the side or back of the package, sunscreens that are not water-resistant will have to say so. 

Sunscreens will now have a fact box listing warnings and other important information in an easy-to-find location as do other over-the-counter drugs. 

Any questions? Of course, there are.

Is it possible that the sunscreen being used is no good? Or in case no one knows how good it comes as a UVA protection. 

Dr. Ganley:

It is not suggested that they be thrown out. Whereas they are surely going to be a level playing field. If you buy a sunscreen labelled SPF 30 and broad-spectrum, after next year, it is sure that you are getting a product that has fulfilled testing required by the FDA. There are different UVA tests by different companies making it difficult to compare products with one another for products on the shelf now. Whereas the inconsistency is the UVA protection, as there is no consistent way to quantify that right now, the SPF tests should be accurate. Here it doesn’t mean you need to throw the products away. 

Does UVA or UVB matter more for causing skin cancer?

To note: forms of ultraviolet radiation are UVA and UVB. Causing sunburns and the more minor skin damage called suntan are the UVB radiations made up of shortwave rays affecting only the outer layer of the skin. Penetrating to deeper levels of the skin, UVA radiation is made up of long-wave rays.

Dr. Lim:

Known to be able to result in skin cancer are both UVA and UVB. It makes skin cancer develop easier as both suppress the immune system. As this is the first time they can tell people that broad-spectrum sunscreen helps prevent skin cancer as the dermatologist as well as the AAD have been very pleased with the new FDA rules.  

How much protection from UVA and UVB will I get?

Dr. Tan:

Here come two separate tests. The SPF test that measures sunburn protection in human studies, should be undertaken by all sunscreens. Hence it is true that the SPF test tells about UVB protection. Done in the laboratory allowing the broad-spectrum claim is the second test called the UVA test. The UVA protection is proportional to the UVB protection in these products as the broad spectrum is a pass/fail. A higher SPF value shows higher protection against UVA when coupled with the broad-spectrum claim.

What does the difference come between water-resistant and waterproof sunscreen products? Are these things factoring into the new regulations at all?

The answer is yes. As they all eventually wash off, no sunscreen will be allowed to claim that its waterproof. Passing a test showing that they maintain their SPF rating after the person gets sweaty or goes swimming should be the sunscreens that claim to be water-resistant. It must be clearly stated on the label either 40 minutes or 80 minutes as to how long the sunscreen keeps protecting the skin. 

For makeup and moisturiser that contains sunscreen, will the labels also change? 

Dr. Ganley:

It will have to include drug facts on the labelling as long as the cosmetic is making some kind of claim regarding sun protection. They can claim SPF or broad range protection if they perform the appropriate testing. 

To Be Continued 

More facts require to be checked when the sunscreens are used. We explain them in the next post.

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