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Color Additives for In-Bath Products

measuring out color

The FDA regulates color additives and their use. For cosmetics, the FDA has a list of color additives permitted for use in cosmetics and each color additive has specifications on how it may be used:

  • “Eye Area” means the area around the eyes. Which is the area from the brow to eyelids, lashes, eyeball and area just under the eye. Color additives must be SPECIFICALLY approved for eye area use.
  • “Cosmetics Generally” means the color additive may be used in any type of cosmetic, except those for eye area use. Colors for “cosmetics generally” may or may not also be approved for the eye area.
  • “External Use Only” means cosmetics applied anywhere on the outside of the body, but not areas covered by mucous membranes (lips, nostrils, ears and genital area).  And not eyes. Colors for “external use only” may or may not also be approved for the eye area.
  • Some color additives may have other specific limitations (such as “hair on the scalp” or “fingernail polish” or “not to exceed .01%”).

In-Bath Products

“In-bath products” include cosmetic products such as bath oil, bubble bath, bath fizzies, or bath bombs—many of which are colored. That brings up the question of what color additives may be used in in-bath products.

According to the definitions above, any color additive for in-bath products must be approved for “cosmetics generally.” Color additives approved for “external use only” would not be acceptable for in-bath products because the color additive would come in contact with the genital area.

Yikes!  But wait…

When I was updating the 1st edition of Soap and Cosmetic Labeling, I wrote the FDA for clarification of this exact point. As a result, the following is what was published in the 2nd edition:

“The FDA has determined that color additives that are approved for external application may be used in in-bath products because of the limited potential of exposure to the color additive.

“Therefore, cosmetics intended for in-bath use may use color additives that are approved for general use or external application in cosmetics in amounts consistent with good manufacturing practices (unless the regulations provide additional limitations).”

With a footnote that read:

“In early 2007 there was conflicting information on the FDA website about which color additives could be used in bubble bath products.  The author queried the  FDA and received the information included here as their official determination on the subject.  The FDA website was subsequently corrected.

Unfortunately, I cannot find my email exchange with the FDA on this – it’s probably in a paper file, in storage. And the FDA website has been thoroughly changed since 2007. I checked the current FDA website and the Internet Archive (archive.org), and couldn’t find the statement being referred to. I KNOW it was there–I was so excited to see that the FDA had updated the site after my correspondence with them!  But now I can’t find it.

So, although I know I did have that documentation, I don’t have in hand anything to prove that they said that “color additives approved for external application may be used in in-bath products because of the limited potential of exposure to the color additive.”  Of course, it’s also possible that they changed their mind on it since then.

Best Bet

What’s the best bet here?

The best course of action when making in-bath products is probably to stick to the color additives that are approved for “cosmetics generally.” That means NOT using color additives that are approved for “external use only.”

Yes, this is going to limit the number of color options, but it will also ensure compliance with the regulations AND will give that little bit of added security and safety to your customer. Since the FDA’s statement to me was based on “limited exposure,” you have the option of protecting your customer from that possible harmful exposure (no matter how little) by eliminating the “external use only” color additives from your in-bath products.

External Use Only

The color additives that are classed as “external use only” and which probably ought not be used in in-bath products are:

Aluminum powder
Bismuth Citrate
Chromium hydroxide green
Chromium oxide greens
Ferric ammonium ferrocyanide
Ferric ferrocyanide
Guaiazulene
Henna
Pyrophyllite
Silver
Ultramarines
D&C Black No 2
D&C Black No 3
D&C Blue No 4
D&C Brown No 1
D&C Green No 6
D&C Green No 8
D&C Orange No 4
D&C Orange No 5
D&C Orange No 10
D&C Orange No 11
D&C Red No 4
D&C Red No 17
D&C Red No 33
D&C Red No 34
D&C Red No 35
D&C Violet No 2
Ext. D&C Violet No 2
D&C Yellow No 7
Ext D&C Yellow No 7
D&C Yellow No 8
D&C Yellow No 11

It may look like a lot, but there are still over 25 color additives that are approved for “cosmetics generally”!

Navigating the Rules and Regs book by Marie Gale

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Comments

17 responses to “Color Additives for In-Bath Products”

  1. Tamara Kohler

    I have a small soap business selling mostly at craft events. Fully licensed and insured through Soapers Guild. I want to make bath bombs and body butters. I’ve read the regulations, I would fall under the fda exemption under 25,000. What I’m totally confused about is mica colorants for bath bombs. I purchased Rolio pigments for my soap. Can those be use in Bath bombs? Those contain synthetic mica coated with titanium dioxides, tin dioxides, and iron oxides. If those are not approved where do I find approved procures. The FDA approved additives say mica can be used. Others places say blue and green are not.

    Another question: is bath bomb covered under my soap liability insurance purchased through the Soap Guild? And must I register with the FDA?

    Reply
    1. Marie Gale

      The answer to your question is a little complicated, but here goes.

      Bath bombs are cosmetics. The only color additives that may be used in cosmetics are color additives that have been approved by the FDA for use in cosmetics (external or general use).

      There are two types of color additives: certified color additives that require batch certification from the FDA before they can be sold, and those that are exempt from batch certification. Color additives that get batch certified (that is, the FDA tests each batch manufactured to make sure they meet the requirements) have special names. The same chemical compound has a name before it is batch certified and then once it’s batch certified it has the new name. For example, Pigment Red 64:1 becomes D&C Red 31 when it is certified.

      Colored micas are a blended ingredient containing mica and other components. Colored micas are used as art supplies and also for coloring soap and cosmetics. When used in COSMETICS, all of the colorants in the mica must the approved for use in cosmetics.

      I looked at three different colored micas from Rolio. The ingredients are stated in Section 3 of the SDS. Parakeet Green contians Pigment Green 7 and Pigment Yellow 98 – neither of which are approved for use in cosmetics (even if they were batch certified). Fandango Pink contains Pigment Red 2 and Pigment Red 146 – also not approved for use in cosmetics. However the Gold powder is colored by Iron Oxides, which ARE approved for use in cosmetics (assuming it meets the purity specifications).

      It looks like Rolio micas are primarily intended for use in art projects, especially epoxy resin artwork. Even though they SAY that they can be used in cosmetic products (soap, bath bombs, nail polish, etc), the color additives they are using are mostly NOT approved for use in cosmetics. If you are going to use them in your products, check the SDS for the specific components and then make sure they are included in the list of FDA approved color additives. (Note that Tin Dioxide is not on the FDA color additives list, but it is used for other purposes in the color blend and is treated as an ingredient, not a color.)

      The insurance you have through the Soap Guild covers soaps and cosmetics, so your bath bombs should be covered.

      Registration with the FDA is required if you aren’t exempt as a small business (to be exempt you must be under $1 million annual sales and not make cosmetic products that are injectible, ingestible, stay on for more that 24 hours and are removed by a professional, or that are applied to the mucous membranes of the eye. So probably not required.

      Reply
  2. Stephanie A.

    Thank you for all the amazing info! I have been making bath bombs and have gotten more serious about manufacturing them. Your articles have helped helped a lot as there is a lot of confusion out there!
    I’ve seen Lush ingredients and seen Ultramarine blue in some of their bath bombs along with the other approved colorants. Are they going by the principal of external use?

    Reply
    1. Marie Gale

      You’re welcome. There is a section on bath products and color additives in my book (Chapter 13, page 147) that explains. The FDA has determined that color additives that are approved for external application may be used in in-bath products because there is limited potential of exposure. That’s why you see Ultramarines in bath bombs.

      Reply
  3. Nicole

    What about Wholesale Supplies Plus Neon Electric Slide Yellow? The ingredients say polyester 3 and yellow 5 none of which is on the list to stay away from. It also states on the website that it is safe to use in bath water. Can you please give me information about this product is it safe to use in bath products?

    Reply
    1. Marie Gale

      The WSP product description states that the ingredients are “Polyester-3 and Yellow 5” and that it is approved for use in cosmetics, but not for eyes and lips.

      The FDA website for approved color additives for cosmetics shows that FD&C Yellow 5 is approved for cosmetics, INCLUDING eye and lip products. BUT Yellow 5 typically isn’t considered a “neon” color. According to the FDA page on Novelty Makeups, there are only a few approved neon colors, one of which is Yellow 7 (not 5). Yellow 7 is only approved for external use (so no eyes or lips).

      This article from Nurture Soap has a good explanation as well, including info about the use of polyester-3.

      Finally, both Yellow 5 and Yellow 7 require FDA certification. If a larger package is opened and then repackaged, then the product requires re-certification. There is a list on the FDA website of companies that have applied for color certification(s) during the past two years; Wholesale Supplies Plus isn’t on the list.

      There appears to be some contradictory information. You might want to check with WSP and make sure the color is a) actually a neon yellow, b) whether Yellow 5 or Yellow 7 is used, and c) if it has been batch certifed (in its repacked state).

      Reply
  4. Tori

    Thank you for clarifying Marie! Your following blog post re: #2 was helpful too. So is there an exclusion for products that are already approved for ingestion? So in the first question I used the example of spirulina so I’ll just stick with that for consistency. Spirulina is an approved food item. Since it is considered “safe” to be ingested could it also be considered safe for in-bath products? Thank you!

    Reply
    1. Marie Gale

      There isn’t any standard for “safe” for cosmetics or in-bath products. It’s up to YOU to determine if the product is safe. It is a pretty good bet that if an ingredient is safe for ingestion it is safe for in-bath use, but not always. Spirulina should be okay, I would expect.

      But, remember that is for an INGREDIENT, not for a COLOR ADDITIVE. If you are using spirulina as a COLOR, it is illegal because spirulina isn’t approved to be used as a color additive. It’s a fine distinction, but keep it in mind.

      Reply
  5. Tori

    So what about herbs that also color? For example spirulina in a bath bomb? Can it be used to color the product but just not listed as a “colorant”? Thank you!

    Reply
    1. Marie Gale

      When an herb also colors, it falls under “is capable of coloring the product” so it IS a color additive. That means it is subject to all the regulations and may only be used in a cosmetic if it is approved for that use.

      That said, if the ingreident:

      1. is used for some other purpose than coloring AND (very important “and”)
      2. the color from it is clearly unimportant to the value, marketability and consumer acceptance of the product

      Then it may be used. Because then it’s NOT a color additive.

      Reply
  6. Tom

    Honestly I’m not sure the FDA has any idea how they determine the safety and the acceptable uses (and amounts) of almost anything.

    Reply
    1. Marie Gale

      I expect they do have an idea (and all kinds of procedures) to determine the safety and acceptable usage and amounts of ingredients, but they have been called into question in the past! The problem is that it takes SO long to make any official changes.

      Reply
  7. Charlotte

    Why is something like Red 33 not allowed in bath bombs when it IS allowed, in certain amounts, in products that touch mucus membranes (lips, mouthwash, etc)? That one confuses me the most. I understand if a product can’t be used on lips, that it can then not be used in any product that may come in contact with mucus membranes (I don’t necessarily agree, but I understand). But Red 33, as an example, CAN be used on lips. Why do some colors have exceptions for certain mucus membrane areas but are not allowed in other areas?

    Reply
    1. Marie Gale

      Honestly, I have no idea how the FDA determines the safety and the acceptable uses (and amounts) of color additives.

      Reply
  8. Karen

    So why are neons not aloud? They say general cosmetics but I am being told not ok for bath bombs.

    Reply
    1. Marie Gale

      “Neon” colors are not defined directly by the FDA. They do have a short section about “fluorescent colors” (which are neon-ish) on their Color Additives and Cosmetics page, which states:

      Only the following fluorescent colors are approved for use in cosmetics, and there are limits on their intended uses: D&C Orange No. 5, No. 10, and No. 11; and D&C Red No. 21, No. 22, No. 27, and No. 28

      Of the colors listed in the quote above, Orange 5, 10 and 11 are allowed for external use only. Red 21, 22, 27 and 28 are approved for general use.

      In order to fully answer your question, I’d need to know exactly what “neons” you are referring to and what the ingredients are. If you have the ingredients, you can look them up on the FDA site to see if they are allowed for general use (and not just external applications).

      Reply
  9. Lori Quail

    Thank you Marie! I know it was there also. I personally spoke to the head of color certification and was told it was ok to use the external colors in bath products also. There are large manufacturers that use some of them, red 33 in particular. I called again, and was told by the same person that technically it was not ok, only because they had not had a request to re classify these colors for that purpose. It would be nice to have clear cut guidelines in for people to follow in easy to read terms and not legal mumbo jumbo.

    Thank you for all your hard work in putting out your informative books that make it easier for everyone to stay compliant!

    Lori Quail

    Reply

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