Sunday, June 26, 2011

*"Let's be careful out there." - Cosmetic Labeling.

Caution: Long post.

"A cosmetic is misbranded if its labeling is false or misleading, if it does not bear the required labeling information, or if the container is made or filled in a deceptive manner.
Section 301 Food, Drug, & Cosmetic Act, US Code of Federal Regulations Title 21

Note: While the International Nomenclature of Cosmetic Ingredients requirement for uniform names is, well, international, the Food & Drug Administration information is specific to the United States, so it is best to check with your individual country's consumer protection laws to see if there may be different requirements or exemptions with regards to cosmetic labeling for selling within your country. However, according to the FDA:

"The cosmetics marketed in the United States, whether they are manufactured here or are imported from abroad, must comply with the labeling requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act, the Fair Packaging and Labeling (FP&L) Act, and the regulations published by the Food and Drug Administration under the Authority of these two laws."

While I know there have been several unscrupulous so-called "indie" companies, who have merely been repackers, private label, or who have deliberately sold re-packaged-non-cosmetically-approved-for-anything soap dyes as "eyeshadow," and who have deliberately ignored requirements for FDA and INCI labeling on their cosmetics; I have also come to discover that there are many respected real indie, as well as even well-known higher-end, cosmetics companies who simply appear to be unaware of all of their labeling requirements under FDA regulations and INCI ingredient naming requirements.
So, I thought I would try to gather some information and advice here to try to help fledgling, as well as existing indie companies, who may not be aware that they have to name ingredients in a specific way, or that ingredients lists must be either labeled on each product, or provide a specific set of alternatives to allow for off-package labeling.

"All cosmetic ingredients must be listed using their official INCI (International Nomenclature of Cosmetic Ingredients) names for all cosmetic ingredients. The use of trade or common names is not allowed on cosmetic ingredient lists. INCI names are uniform scientific names. INCI names are mandated on the ingredient statement of every consumer personal care product." 
-International Cosmetic Ingredient Dictionary and Handbook

The importance of the INCI naming requirements cannot be overstated, especially with regards to people with severe allergies and other autoimmune disorders. The uniformity of the ingredient names makes it possible for people who know they have allergies to readily identify products with the ingredients to which they are allergic, and using trade or common names can lead a person to not realize that a product actually contains an ingredient to which they are allergic, which could result in anything from minor itching to full-on-get-your-@$$-to-the-hospital-NOW-anaphylactic-shock, which, from personal experience, is one of the scariest things ever to go through, and not something I would ever wish on my worst enemy.
For cosmetics in store displays, there is only one allowance for a separate off-product ingredient list pamphlet or flier, and the product must meet all three of these conditions to be allowed to have a ingredient list not attached to each individual product, and there must be enough fliers/pamphlets available for each individual product:
(1)The product is not enclosed in an outer container, AND 
(2)The total package surface area is less than 12 square inches, AND 
(3)The products are held for sale in tightly compartmented trays or racks.
Even in the store, there must be enough pamphlets or fliers so that there is one available for every individual product that meets the 3 exemption requirements, & if the store runs out of the pamphlets/fliers for an item, there must be a sign under where the pamphlets/fliers are removed from the mounted stack, that says, "FEDERAL LAW REQUIRES INGREDIENT LIST TO BE DISPLAYED HERE." 21.CFR701.3(j)

Despite this exemption, and Sephora Brand lipsticks meeting all these criteria, they still put individual "peel here -->" type removable INCI ingredient list stickers on all their in-store lipsticks. Wet-n-Wild lipsticks also usually meet all these exemption requirements when in drugstore displays, yet they still print all their ingredients on their shrink-wrap.
On the other hand, at Victoria's Secret, I purchased some Beauty Rush Cheek Tints that barely met two of exemption conditions, with the printable surface area of the shrink-wrap being 11.14² inches, while laying out on an open, non-compartmentalized display. When I asked where the ingredients list was for the product was, it took 10 minutes of shuffling around behind the counter before a sale associate finally appeared with a list of ingredients for certain Beauty Rush products, including a "Beauty Rush Lip & Cheek Pop," but not any for the "Beauty Rush Cheek Tint."

For comparison, this is the ingredient list I got from the store, for "Beauty Rush Lip & Cheek Pop," that is not broken down by shade, and is not the product that I purchased, which I pointed out to the sales associate, who said that it was the only ingredients list they had:

Water (Aqua, Eau), Propanediol, Glycerin, Sodium Stearate, Flavor (Aroma), Phenoxyethanol, Aluminum Hydroxide, Methylparaben, Hydrated Silica, Butyparaben, Ethylparapen, Isobutylparaben, Propylparaben, Geraniol, MAY CONTAIN (+/-) Titanium Dioxide (CI 77891), Red 22 (CI 45380), Red 33 (CI 17200), Red 40 (CI 45410), Yellow 6 (CI 15985)

It took 10 days of online searching & contacting VS multiple times, while not wearing or swatching my products until I got a straight answer, before they finally released the actual ingredients for my 3 "Beauty Rush Cheek Tint" colors.

*Beauty Rush Cheek Tint "Just Peachy": Ingredients: Caprylic/Capric Triglyceride, Trimethylolpropane Triisostearate, Hydroxystearic Acid, Isostearyl Isostearate, Diisostearyl Malate, Polyisobutene, Isononyl Isononanoate, Ricinus Communis (Castor) Seed Oil, Ceresin, Fragrance (Parfum), 1,2-Hexanediol, Caprylyl Glycol, Benzyl Salicylate, Citronellol, Hexyl Cinnamal, Hydroxycitronellal, Linalool, Mica, Yellow 5 Lake (CI 19140), Titanium Dioxide (CI 77891), Red 6 Lake (CI 15850), Yellow 6 Lake (CI 15985). 

*Beauty Rush Cheek Tint "Mon Cherry": Ingredients: Caprylic/Capric Triglyceride, Trimethylolpropane Triisostearate, Hydroxystearic Acid, Isostearyl Isostearate, Diisostearyl Malate, Polyisobutene, Isononyl Isononanoate, Ricinus Communis (Castor) Seed Oil, Ceresin, Fragrance (Parfum), 1,2-Hexanediol, Caprylyl Glycol, Benzyl Salicylate, Citronellol, Hexyl Cinnamal, Hydroxycitronellal, Linalool, Red 6 Lake (CI 15850), Red 7 Lake (CI 15850). 

*Beauty Rush Cheek Tint "I Pink I Can": Ingredients: Caprylic/Capric Triglyceride, Trimethylolpropane Triisostearate, Hydroxystearic Acid, Isostearyl Isostearate, Diisostearyl Malate, Polyisobutene, Isononyl Isononanoate, Ricinus Communis (Castor) Seed Oil, Ceresin, Fragrance (Parfum), 1,2-Hexanediol, Caprylyl Glycol, Benzyl Salicylate, Citronellol, Hexyl Cinnamal, Hydroxycitronellal, Linalool, Titanium Dioxide (CI 77891), Red 7 Lake (CI 15850), Red 6 Lake (CI 15850).

As you can see, the ingredients I was given at the store in no way remotely resemble the ingredients that I had to pry out of VS's customer service. If I had not been so insistent about getting the real ingredients, I would have ended up probably using them as art supplies rather than makeup, as I would have had no idea if one or more of them had the FD&C Red No. 40 (to which I am particularly sensitive) that was listed under the VSL&C Pop ingredients, which would have really sucked, as "Mon Cherry" has become one of my favorite blushes, and the one blush that people compliment me on the most. Also, as you can see, the VSL&C Pops are loaded with parabens, to which some people, especially with autoimmune disorders, have allergic-type reactions, yet the VSCTs have no parabens, or Red 40 for that matter, listed anywhere. So, VS actually did themselves a huge disservice, not only in violating the FDA labeling requirements and "misbranding" their Cheek Tint products, but also likely losing a large number of potential sales of the Cheek Tint product to people who avoid parabens, who might have bought it if the ingredient list provided at the store [for a completely different product, with a slightly similar name] hadn't indicated that it contained 5 different parabens, which I suspect may exceed the RDA for parabens for even healthy people. <;-)

My Birchbox this month contained a full-size Laura Geller Blush-N-Brighten in "Honey Dipped", which is way too dark, shimmery brown for me to use as a blush, and with my nearly albino pale pink complexion, bronzers are just not an option and look completely unnatural on me,  and if they have too much yellow, can make me look oddly jaundiced. There are no ingredients whatsoever listed anywhere on this full-size product that retails for $29.50, and at first I could not find the ingredients listed online either. The only real use I could think of for this color would be as eyeshadow, so I asked Birchbox if they might happen to know if it could possibly be eye-safe, since most blushes I've seen are not, but I was told, yes, it could be used wet or dry, like any baked eyeshadow. Fortunately for my eyes, I finally did find the ingredients for the Laura Geller Blush-N-Brighten products online:

All shades: Talc, Mica, Mineral Oil, Dimethicone, Polysorbate 20, Glyceryl Ethylhexanoate/Stearate/ Adipate, Magnesium Aluminum Silicate, Polyacrylamide, C13-14 Isoparaffin, Laureth 7, Octyldodecyl Stearoyl Stearate, Isopropyl Myristate, Sorbitan Stearate, Sodium Dehydroacetate, Phenoxyethanol, Zea Mays (Corn) Starch, Ethylhexyl Methoxycinnamate, Methylparaben, Cetearyl Ethylhexanoate, Tocopheryl Acetate, Simmondsia Chinensis (Jojoba) Seed Oil, Isopropyl Palmitate, Lauroyl Lysine, Ethylparaben, Propylparaben, Imidazolidinyl Urea, Butylparaben, BHT, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499), Chromium Oxide Greens (CI 77288), Carmine (CI 75470), Ultramarines (CI 77007), Red 7 Lake (CI 15850).

Red 7 Lake is not FDA-approved for use around the eyes, and it is not in a "May Contain" section, implying that it is in all the shades. I had thought maybe another use could be to scrape some off into a gloss or lip balm base & make a new lip color, but the Chromium Oxide Green and Ultramarines in it preclude its use on the lips as well. This is purely a blusher/bronzer that has colorants that are not FDA-approved for use around the eyes or the lips, and it should not have to take pushiness tenacity, internet access, a moderate knowledge of which colorants are not eye-safe &/or lip-safe, & finally tracking down the ingredients online, to know that it did contain a non-eye-safe colorant, after being told by the distributor that it was eye-safe, when an ingredients list on the product would have answered my question right off. I then asked Birchbox, even though it was a full-size blush, with over 15² inches of label space, if it was some kind of a special edition made specially for Birchbox's sample program, because I was shocked that it had no ingredients on it, or accompanying it. They said it was a regular Laura Geller blush (that is sold in stores like Macy's and Ulta) and the ingredients were online. While samples do not have to have printed ingredients with them, as a full-size product, it should have had the ingredients on/with it. Although, if samples do have ingredients, and especially if they also say whether they are eye and/or lip-safe, and if the shade is vegan, I am much more likely to use the samples, since I don't have to spend time and energy looking them up or emailing to request ingredient lists, and if I use the samples, I am more likely to purchase the full-size product.

While I absolutely prefer it when a seller does post their INCI ingredient lists online, as it is much less of a hassle for both the seller and me, if I don't have to email them to ask for what the ingredients are for a number of different products in which I may be interested; the law has not yet evolved enough to take into account online cosmetics sellers, and while not explicitly required by the Code of Federal Regulations, a lawyer for the FDA, or a consumer protection attorney, could argue that an online ingredients list may be necessary to ensure that the FDA requirement that, "The ingredient declaration must be conspicuous so that it is likely to be read at the time of purchase," is met. If not posted, there should at least be a readily apparent way to contact the seller to ask for an ingredients list. While online ingredient lists can save both you and your customers time and energy from having to individually ask for ingredients lists, and is likely to become a requirement in the future to meet the intent of the FDA's requirements, they are still not a substitute for providing the proper labeling/fliers for the individual products with their INCI ingredient lists.

If a brands like Victoria's Secret and Laura Geller, can fail to meet FDA requirements for even having an ingredients list on/with a full-size product at all, I can only imagine how difficult it could be for a small indie shop, often 1-2 person operations, to keep from making a mistake, and the last thing I want to see is real indie shops getting into trouble, and having my favorite products considered "misbranded" by the FDA, because of a failure to provide INCI ingredients lists for all full-size products in the order, or because of a use of non-INCI names in ingredients lists, because they either missed the specific information, or misinterpreted it, while trying to research the information, which can be very detailed, nuanced, and full of legalize. I also think that the callousness exhibited by the aforementioned few allegedly "indie" companies has scared many consumers, who may be quicker than they would have been previously, to see a mistake like a discrepancy in ingredients, and jump to the conclusion that the company is one-of-they-who-shall-not-be-named.

I would encourage cosmetics companies who exclusively distribute to consumers by direct mail to still label their products as they would be if they were sold in a store, because who knows when your company may catch the eye of a physical store who would like to carry your products right away, and you might miss the opportunity if you have take extra time to design proper labels or affix-able tags. It also would help circumvent the potentially unfortunate consequence of a person making a large order, and then giving some of the products as gifts to friends, creating the likely possibility that one of the buyer's friends may have, or suddenly develop, an allergy to an ingredient, but if they can't see the ingredients on the product, a newly allergic person will have a much more difficult time trying to identify the allergen so that they can avoid it again in the future, and a previously allergic person may be allergic to more than one thing, as well as being even more prone to developing new allergies, and so may also have no idea what the culprit ingredient might have been without access to the ingredients list.

However, the FDA does allow the option of an alternative to the declaration of ingredients on an affixed label or tag, for cosmetics sold exclusively & directly through the mail, provided it meets all of the following requirements:
*The declaration of ingredients may appear in letters not less than1/16of an inch in height in labeling that accompanies and specifically relates to the cosmetic(s) mailed, or in labeling furnished to each consumer for his personal use and from which he orders cosmetics through the mail, e.g., a direct mail sales catalog or brochure, provided all of the following additional requirements are met:
(1) The declarations of ingredients are conspicuous and presented in a way that permits the consumer to identify the declaration of ingredients applicable to each cosmetic.
(2) The package mailed to the consumer is accompanied by a notice located on, or affixed to, the top of the package or on top of the contents inside the package, or on the face of the package platform surrounding and holding the product(s), readily visible to the consumer on opening of the package, and provides the following information in letters not less than 3/16 of an inch in height:
(i) The location of the declarations of ingredients, e.g., in an accompanying brochure, or in a sales catalog used for ordering;
(ii) A statement that a copy of the declaration of ingredients will be mailed promptly to any person requesting it; and
(iii) The name and place of business of the mail order distributor,
(3) The mail order distributor promptly mails a copy of the declaration of ingredients to any person requesting it.

I would personally find this alternative more cumbersome than making a label or an affixed card that doesn't require one to be "on call" to promptly mail ingredients lists when requested, is more likely to help protect the company legally if the cosmetics are given away to someone who has a reaction, but has no access to the ingredients list, and would help prevent the reactions in the first place, at least for people who know what they are allergic to. However, for the time being, it is an allowable alternative.

If designing labels or cards for each product is not your forte, perhaps a fun PR campaign could include having a contest for people to design labels or affix-able ingredients list cards. If you are just a customer and fan of an indie company that you know doesn't have a lot of resources, and you are good at label/card design, perhaps you could volunteer or offer to trade your services for makeup. This would sound silly if I were talking about large corporate makeup companies, but there is a reason that there is a concept of an indie makeup community.

*Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices
*A Closer Look at INCI Label Laws
*FDA Cosmetic Labeling Manual - October 1991
*Labeling Regulations Applicable to Cosmetics (Code of Federal Regulations, Title 21)
*Summary of Regulatory Requirements for Labeling of Cosmetics Marketed in the United States - October 1991; updated June 18, 2009
*FDA Cosmetics Handbook, including Cosmetic Good Manufacturing Practice Guidelines
*The Cosmetic Ingredient Dictionary
*FDA Recall Policy for Cosmetics
*Bad Reaction to Cosmetics? Tell FDA
*Use Eye Cosmetics Safely
*FDA Resources For You: Cosmetics Manufacturers, Packagers & Distributors                                                          
Take this quiz and earn a certificate!
*Bonus points if you're old enough to *remember* (looking it up on Google doesn't count, ya cheetahs!) what TV show made the title quote popular. ^~ᴥō^
♥ Miss Jupiter
^☼ᴥ☼^ <---Mascara Kitteh!


  1. This is incredibly well researched and presented! Thanks for putting this out there; I can attest to the fact that it is *not* easy to navigate the FDA regulation waters.

  2. I agree with this heartily, with the exception of it's not HARD or time consuming to properly list your ingredients AT ALL. Most suppliers list the INCI name with the item listing. All you need is a template for whatever your label/sticker is (staples, avery, and provide FREE templates for everything even MS Office and Open Office have built in templates for most common sizes or go to Martha and download some pre-made fancy ones if that's your excuse) and copy and paste. If you're in indie cosmetics/b&b there is no good reason you have to not list your ingredients. If you claim that you didn't know you had to, well you shouldn't be in business.
    I've found over the years as being a customer, and both an biz myself that companies that do not do full disclosures of ingredients are trying to hide something i.e that they use parabens as a preservative, or a "vegan" eye shadow actually, oops, contains carmine, or just a smidge of something that's not lipsafe in a lip product (but it's "ok" cause it's just a smidge I can leave it out no one will know). As a customer full disclosure (where it doesn't violate trade secret) is essential to me, I'm allergic to parabens, certain variations of sulphates, and have celiacs, which means I can not use anything containing wheat/barely, derived from wheat, wheat germ oil (or vitamin e derived from wheat germ), or gluten especially lipsticks that have "flavor/scent" that's not otherwise stated to be gluten free. For me the choice is pretty simple, no/or incomplete ingredients listed I don't purchase and I tell my customers the same.

  3. It amazes me that these big companies are breaking the law and getting away with it.

    Thanks for the post really informative.

    Rach - The Myasthenia Kid

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