FDA Labeling Requirements

The MOMENT you stray away from soap, your product is considered a "cosmetic." Cosmetics have strict labeling requirements that are mandated by the FDA. While the FDA does not actually actively police small company labels, the laws have been set in place for YOUR protection. All companies have stumbled a bit to get to 100% compliance with these rules. I, myself, still have rogue labels here and there missing "directions." 

  1. Label must cover at least 40% of the container (excluding top and bottom)
  2. Product name (can be fanciful, but then must also include a common name- like “sugar scrub”)
  3. Net quantity of contents (weight excluding container)
  4. Name and place of business
  5. Directions for safe use (if product can be misused)
  6. Ingredient font may not measure less than 1/16 inch in height
  7. ALL Ingredients are listed in INCI* name in descending order
  8. Exceptions to the INCI rule are ingredients that make up less than 1% of the total formula, fragrance, flavoring, and colorants. (You still need to SAY colorant, fragrance, preservative, etc., though.)

*INCI stands for International Nomenclature of Cosmetic Ingredients. At the time of this blog writing, in the USA, it is still permissible to use more common names (CTFA editions 2-11) of ingredients on labels. HOWEVER, if a company wants to ship internationally- they need to use INCI codes. For an interesting summary of this topic, check out LotionCrafter's site.

But the point I am trying to make with this post is that you want to know that a company is AWARE of these regulations and working diligently to comply with them. It's simply the right thing to do. Consider what it could mean if a company's label is completely ignoring the FDA.

Do they have any IDEA that cosmetics have rules? If not (to be quite blunt), what business do they have making your skincare products? FDA labeling requirements are no secret and widely discussed and referenced in the industry. A person would have to literally wake up and start both a hobby and a business on the same morning. (Which is also scary, isn't it?)

Do they just not care? If they know and do not care, what does that suggest about their other business practices? 

Again, we've all stumbled and we've all made mistakes. But you can still see when the effort is being made! =)

Happy bunny trails! Love, Jenna

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7 comments

Lore Porter: I would say this could be a bit of a tap-dance if you needed it to…. Logically, you could argue that the ingredients on a card along with the bath bomb or on the bag (that is part of its packaging) should be fine. If someone wanted to argue that they could become separated…. well you could also discard the shrink wrap long before using and that is also separating the label from the product. I could have the same problem- I print mine on a tag and attach it with string and a sticker. I would not worry so long as your ingredients are easily accessible online as well as on the bag.

Jenna

Okay my question is because I shrink wrap my bath bombs but then when I go to sell them I put them in a Kraft paper bag do I have to put the ingredients list on the shrink wrap bag or can I put it on the paper bag

Lore Porter

Kristie, as of this writing- you do NOT need the INCI codes for labels of items for domestic use. “Common names” are acceptable. But honestly- you never know when that could change!

Jenna Moll

Question, I cannot find the answer anywhere. Do you know if you have to use the INCI name on labels in the US? I don’t plan on shipping outside the US at this time. Thanks in advance :)

Kristie

Dave, there is no functionality for me to reply to your comment, so hopefully you check back! I do not believe that the amount per year has any bearing on your labeling requirements… it simply makes you less likely to garner attention from the FDA.

For bath bombs, my suggestion would be to include the ingredients, usage instructions (drop into a bath tub and allow to dissolve), and if she wants to be really careful, a warning such as “be careful when standing in the tub, this item may make the surface slippery” if that applies to her.

Now, those are just if she wants to be completely covered. I don’t include usage or warnings on my labels, personally.

Jenna Moll

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