Blended Color Additives

Color additives in cosmetics continue to be a difficult topic. Blended cosmetics are especially problematic. Keeping your products legal requires diligence and an understanding of color additives and the regulations.

Why “blended colors”?

A blended color additive is one that is made with a combination of color components. It may also have other ingredients to make them work.

Face it, there are only so many color additives permitted by the FDA for use in cosmetics.  There are 29 ingredients (like mica or ultramarines) and 36 D&C or FD&C colors (the “dyes”).  Of those dyes, there are only a few color groups:  black (3), blue (2), green (4), orange (4), red (14), violet (2), and yellow (7). The only way to get all the unique colors out there is to blend approved colors to make new colors.

Think of all the nail polish or eye shadow colors on the market! Those are blended combinations of approved color additives.

Who makes blended color additives?

There are huge companies that make color components–for cosmetics as well as other industries. Paint, for example, has very creative blends of color components, but paints don’t need to be approved for cosmetics. There are also some smaller companies that make or buy blended color additives and cater to handcrafted soap and cosmetic makers.  Mad Micas comes instantly to mind1I want to thank Joanna Schmidt of Mad Micas for her assistance in understanding the color additive industry..

Selecting the right color additive for your product

Not all color additives are equal. The trick comes in selecting the RIGHT color additive for your product. That is, a color additive that is LEGAL to use in your product.

A note about soap:

If you are making soap that is exempt from the definition of a cosmetic, you aren’t restricted to color additives approved for use in cosmetics. HOWEVER, you are still responsible for the safety of your soap. Consider carefully if you want to use a color additive that hasn’t been approved for use in cosmetics and on the human body, and if you do want to use it anyway, make sure it is safe for use.

Besides the color itself being what you want, here are some things to look for in deciding which color additive to use:

1. Has the supplier said it is “not for cosmetic use”?

Generally that means that it contains a color additive that isn’t approved for cosmetics. Don’t use it in a cosmetic product. Consider carefully whether you want to use it in soap.

2. Has the supplier provided the component ingredients of the color additive?

It is your responsibility to put all the component ingredients in your ingredient declaration (and to ensure that they are safe). If the supplier doesn’t provide you with the list of component ingredients, you are at risk. Choose a different color additive if at all possible (or a different supplier).

3. Are all the component color additives matched for the intended use of your product?

The FDA’s chart of color additives for cosmetics lists the approved use of each. Many of the color additives have restrictions, so be sure to check the list.

General Use: Can be used generally, including in lipstick (but not eye area, unless specifically approved for such).

Eye-area: All around the eye, including the eyebrow. Lakes are not approved for eye-area use except if specifically stated.

Externally applied cosmetics: External body, except for eye area and lips (or any area covered by mucous membrane). If a color is rated for “external” use, you can’t use it for lip products unless it is specifically approved for such.

NOTE: Color additives in bath products, such as bath fizzies or bubble bath, do come in contact with mucous membranes (genital area, mostly). When I queried the FDA about this, I was informed via email that color additives approved for external use would be acceptable for in-bath products because of the small quantity of contact. This is not specifically stated on their website and the regulations may (or may not) be interpreted in this manner by an inspector. Be wary.

4. If there is a component in the blended color additive that is not on the approved list, is it actually a color additive?

In some cases, a blended color additive might contain other ingredients that don’t need to be on the approved color additive list. An example is tin dioxide, which is used as a bulking agent, opacifier, or texturizing agent. If there is something in the ingredient list that isn’t an approved color additive, check with the supplier to see what its purpose is. Normally it would be added to the ingredient declaration with the other, non-color, ingredients.

Bottom Line

If a cosmetic contains a color additive that is not approved for the way it’s being used, the cosmetic is “adulterated”.  That means the product is illegal.

The bottom line is that if you make a cosmetic product, you are responsible for ensuring that your product isn’t adulterated through containing a non-approved color additive.

  • Only use approved color additives in cosmetics.
  • Keep records.
  • Protect yourself and your business.

References

References
1 I want to thank Joanna Schmidt of Mad Micas for her assistance in understanding the color additive industry.

Comments

6 responses to “Blended Color Additives”

  1. Marie, I have looked everywhere and I can’t find anything about polyester 3 that is used in some colorants. It appears it is allowed but without something specific I am leary.

    1. Marie Gale

      Polyesters are typically used in glitter-type products. The FDA has said that they aren’t approved as a color additive, but they have also not enforced it for years. I tried to get some official information from them, using the Freedom of Information Act (FOIA). I didn’t get anything specific back, but I did find references to a “guidance document” and other communications that seemed to imply that they weren’t going to enforce—at least for now. The guidance document was apparently never finalized or approved. I didn’t get the document, only references to the fact that it was being drafted.

  2. Thank you. I looked up Color Additives Permitted for Use in Cosmetics, and the list has good information. I rarely use color additives, and mainly mica, but this is good to know. Now to find out if additional preservatives are needed by adding color.

    1. Marie Gale

      Color additives, by themselves, shouldn’t require additional preservation. If the color additive is diluted in water, or if it is a botanical ingredient, then it might. But usually the amount of a color additive is so small that it would typically be covered by the preservation system in place for the product.

    2. Kelly Chambers

      Hi. I just got my ingredients list for my micas and they include pigments like yellow no 12 and blue 15:3 and Red 245. I can’t find anything about these colors. Are they ok if used in mica for cosmetics?

      1. Marie Gale

        Yes, colored micas normally contain dyes (those are the ones with numbers). The FDA has a list of color additives that are approved for use in cosmetics. It also lists any restrictions on the use (if okay for eye area, etc.). Your supplier should provide details of any restrictions for use of the color, based on the color additives used to make it. I hope that “Yellow no 12”, “Blue 15:3” and “Red 245” were just made up examples–none of those exist in my reference materials!

        You do need to include all those color additives in your ingredient list. The good news is that color additives can go at the end, in any order regardless of the amount, so it’s pretty easy.

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