The Truth About SPF And Mineral Makeup
In a personal letter from the owner, Katherine, she explains in detail about FDA and FTC Compliance.
Also provided is the latest FDA Compliance Mandates for 2012 which is entailed in the article SPF Claims In Mineral Makeup and Skincare. This article also shows examples of what an FDA “over the counter” drug label should look like in order to be FDA compliant. And all sunscreens are declared OTC drugs.
UPDATED 2013 - TAKEN FROM FDA WEBSITE:
FDA now requests data and information on different dosage forms of sunscreen products. The agency currently considers sunscreens in the form of oils, creams, lotions, gels, butters, pastes, ointments, sticks, and sprays to be eligible for potential inclusion in the OTC sunscreen monograph – meaning that they can be marketed without individual product approvals.
However, the agency currently considers wipes, towelettes, powders (minerals), body washes, and shampoo not eligible for the drug monograph. Therefore, they cannot be marketed without an approved drug application under section FDA 2011a,b.
IMPORTANT FACT: In short, this means that even with a compliant drug monograph on the label, mineral makeup manufacturers who currently make this claim are in violation of FDA regulations unless the FDA has approved their application to allow them to profess their proven claims and receive OTC status. In fact many other mineral makeup manufacturers are already notifying their customers that sunscreen claims are being removed from all packaging and marketing materials based on the new regs. Others will either do so more discreetly and out of the public eye, or they'll continue to ignore and violate the new FDA regulations, and this includes notating them as "active ingredients" on the label.
Even though Zinc Oxide and Titanium Dioxide are approved by the the FDA as broad spectrum sun-blocking agents, and they are contained in our mineral makeup products, making sun protection factor claims is not something we will ever do.
Be Wary Of The Skin Cancer Foundation Seal Of Approval And American Cancer Society Logos
Hundreds of sun protection products bear the Skin Cancer Foundation’s Seal of Recommendation, but this certification is granted only to manufacturers who join the Foundation’s Corporate Council at a cost of $10,000 a year. The Foundation claims to set “stringent criteria” for sun protection, but it's seal is based on requirements that are less rigorous than those of the American Academy of Dermatology. In May 2012 however, the Skin Cancer Foundation brought its requirements in line with the FDA’s 2011 standards for “broad spectrum” UVA / UVB protection, a move that will rubber-stamp nearly every sunscreen on the market as being safe. Yet remember, FDA no longer will allow powders to bear the OTC monograph without application for approval under their new drug laws, so this seal would also be invalid for these sunscreen products currently using it.
Some sunscreen products bear the logo for the American Cancer Society, giving the impression of a ringing endorsement. However, it has been made clear on the ACS website, they do not endorse these products but that a royalty fee has been paid to use their logo.
Going One Step Further Without Ambiguity
FTC and FDA are very clear in spite of the new regulations; an SPF claim or it's approximate, or even referring to the mineral makeup as being a “natural sunscreen” has always been in direct violation of their regulations, based on the fact that Titanium Dioxide and Zinc Oxide bear the monograph as an “over the counter drug” (OTC), approved for use as broad spectrum UVA and UVB sunscreens.
So, with the new FDA mandates for OTC Monographs, the prerequisite FDA approved testing MUST be completed by each individual mineral makeup company, on each individual shade and each and every batch, proving their SPF claims we exampled above. Furthermore, terms such as “sunblock” and “waterproof” or “sweatproof” are banned completely under new FDA regulations in any context.
Simply put, the best advice is to experiment with our mineral makeup products and see how they perform for you in the sun. Every individual is different as is every application technique! Plus, this is also the main reason FDA created the new rules for powders since to achieve the SPF claims being made by brand X, it requires far more coverage than what is actually used or advised in makeup application. With the FDA ruling on mineral powders, it is not something we'll pursue since in doing so makes the manufacturing of our products cost prohibitive, and the look of application will be less flattering in order to achieve SPF rating claims.