What’s on your sunscreen label?
Sitting outside on this hot, sunny summer weekend got me thinking about SPF products. Here’s an article researched by Irene, our intern from France. (Some of you met her at the NYSCC Supplier’s Day). We wrote it together, and would certainly appreciate your comments! Happy Reading!
It’s coming!! UVA and UVB Broad spectrum In vitro Testing will be required for sunscreen products at the end of this year. Because of the cost and time it takes to ensure your products meet the new requirements, it’s important to start considering the implications of the new FDA requirements for your products.
As mentioned above, sunscreen products will have to pass an in vitro test called a “critical wavelength” test or “broad spectrum” test. The SPF on the product label will be expressed as “Broad Spectrum SPF” followed by the numerical SPF value calculated according to the test method described in 21 CFR 201.327(i). (LINK)
The good news is that these new sunscreen labeling regulations have been delayed for six months by the U.S. Food and Drug Administration (FDA): Originally set to take effect June 1, 1012, the effective date of the regulations was moved to December 2012 for major manufacturers and to December 2013 for small manufacturers.
Ok, so, I know what you’re thinking: “What is this Broad Spectrum Test?” Or even more likely, “How long does it take, and how much is it going to cost me?”
Well, I’ll start with the answer to the first question. As those of us in the industry know, both Ultraviolet A (UVA) and Ultraviolet B (UVB) solar radiation can cause skin damage, like sunburn, skin cancer and premature skin aging. Sunscreens products with the Broad Spectrum SPF designations contain organic or physical UV filters which provide protection against both UVB and UVA radiation. It is important to keep in mind that sunscreen products were originally conceived in order to protect the skin of harmful UVB rays which result in sunburns. For a number of years, it’s been suspected that UVA rays also cause damages to the skin. Recently, North American regulatory organizations such as the FDA (and therefore Health Canada which follows the FDA) have required that solar products should protect against both UVB and UVA rays.
Broad Spectrum Test or Critical Wavelength Test (in vitro) is conducted according to the FDA Monograph 21 CFR 301.327(j) published at 76 FR 35620 on June 17, 2011. The Critical Wavelength (CW) is defined as the wavelength at which the integral of the spectral absorbance curve (meaning the sum of all absorbance under the curve up to 370nm) reaches 90% of the integral over the UV spectrum from 290 to 400 nm. It has been decided that this value must be equal or over 370 nm so as to classify a product as broad-spectrum. More simply, CW is defined as the wavelength at which 90 percent of the total area under the absorbance curve, with the absorption measures across the UV spectrum. In the current ruling, the FDA has adopted this pass/fail test using the in vitro critical wavelength (CW) as the only method.
Following this newly required in vitro method, Samples of test product are irradiated with UV light and measures of the spectrum of light transmission through the test products are conducted to determine their capacity of countering UVA and UVB light rays. This In Vitro “Broad spectrum” test allows to verify the quality of products and to substantiate the “Broad spectrum” claim made on the label by the manufacturer.
From the results of this in vitro test, we can find out whether the test product:
1. Provides a sufficient ”critical wave length” (superior to 370 nm),
2. Is in accordance with the claimed SPF on the label.
Why is this “Broad spectrum” test important?
- The first reason is that it serves to reassure consumers that their sunscreen is effective against the damaging rays of both UVA and UVB radiation.
- Secondly, the label claims for a product deemed a Broad Spectrum Sunscreen provide consumers the information they need to make an informed choice when purchasing sunscreens
- Thirdly, the Broad Spectrum claim gives a sunscreen product an added layer of credibility with customers
- Fourthly, and most importantly, products tested for broad spectrum effectiveness guarantee the protection of your customers from both UVA and UVB solar radiation.
Now that you have the long version answer to your first question, let’s address your second question: How long does this test take, and how much is it going to cost?
Answer: This in vitro test does not take very long, but it is in addition to the regular in vivo SPF tests that your product must undergo. It is recommended that this test is conducted first, to ensure your products are meeting your expectations (or your marketing director’s expectations) for broadspectrum coverage, as this test is faster and less expensive than the in vivo test. For exact pricing (dependent on the number of products tested at the same time) please contact Stefanie Hostetter at shostetter@evalulab.com or (604)698-8658.
For more information on the changes to the FDA’s Sunscreen Monograph, see there Related Web Links :
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM259001.pdf
http://www.lhsfna.org/index.cfm?objectID=E9B9329B-D56F-E6FA-9D655362A3C11AC4
