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.

The Truth About SPF And Mineral Makeup

In short, there is no doubt Zinc Oxide and Titanium Dioxide are proven to be effective sun-blocking agents, and they are contained in our mineral makeup products. However, on any products that offer these two ingredients as sunscreen, there must have been the required FDA approved clinical studies performed to make an SPF claim. The label must contain a drug monograph with “active” ingredients highlighted.

According to the FTC and FDA, making an SPF claim or its’ approximate, or even referring to the mineral makeup as being a “natural sunscreen” is 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, unless the prerequisite FDA approved testing has been completed by each individual mineral makeup company proving their SPF claims, they cannot state any of these terms above in bold, legally. Furthermore, terms such as “sunblock” and “waterproof” or “sweatproof” are banned completely under FDA regulations in any context.

Unfortunately, making SPF claims without the actual FDA testing is widespread among many mineral cosmetics companies on the market today, including some that will also show the ingredients as “active”, but fail to display a full drug panel monograph of safety, usage and warnings. Then it boils down to truth in labeling.

Simply put, the best advice is to experiment with our mineral cosmetics and see how they perform for you in the sun. Every individual is different as is every application technique! Plus, this is the main reason we have not pursued an SPF Rating since it is subjective to use, and does not warrant the expense of testing. Costs can reach into the hundreds of thousands of dollars since each color would require its’ own series of tests.

Be aware, for any of those that may have actually received an SPF Rating, never advise how much must be used to achieve the rated SPF. Since mineral makeup is rarely used for heavy coverage, it typically will not reach the level of sun protection factor declared. Especially darker colors, since these shades possess far less Titanium Dioxide and Zinc Oxide due to these being designated colorants also, whereby reducing the SPF number claimed. Yet companies will rarely make this distinction to their customers.