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Cosmetic ingredient labeling requirements???
For labeling ingredients on cosmetic products: can you list the ingredients on your website instead of on the actual product?I can’t find anything on the FDA website about this, however I noticed that “Chapstick” sells tubes in the stores that do not have the ingredients listed on the tubes. How do they get away with that?My space is very limited on the lip balm tubes and I am struggling to fit a bar code on it.
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6 Replies
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No, you can’t do that.
Chapstick often sells the product with a blister package and they put the ingredient list on the cardboard insert. But when they don’t have the blister package, they put the ingredient list on the tube.
https://www.chemistdirect.co.uk/chapstick-medicated-stick/prd-3c5
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This site has lots of information21 CFR 701.3(b) and (p)
The ingredient declaration may appear on any information panel of the
package which is the outer container in form of a folding carton, box,
wrapper etc. if the immediate container is so packaged, or which is the
jar, bottle, box etc. if the immediate container is not
packaged in an outer container. It may also appear on a tag, tape or
card firmly affixed to a decorative or small size container.There are also exemptions for small pack sizes that allow for off label packaging but it requires leaflets be available the point of purchase.21 CFR 701.3(i)
The declaration of ingredients in labeling accompanying a cosmetic, i.e., off-package ingredient labeling, requires that:
(1)The product is not enclosed in an outer container,
(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.
The ingredient declaration must be in letters not less than 1/16 of
an inch in height and may appear on padded sheets, leaflets or similar
labeling accompanying the product.Products which are not eye or facial make-up
cosmetics or nail enamels must be displayed for sale in tightly
compartmented trays or racks of a display unit. The holder of the padded
sheets or leaflets bearing the ingredient declaration(s) must be
attached to the display unit.I think you will also find that Chapsticks are also considered drugs as they are marketed as skin protectants and sunscreens so the labelling requirements will be different. -
Thank you both. This one was not a blister package.. but I figured I would have to list ingredients.
@ozgirl: Lip balms are only considered drugs based on the claims you make about them. If you claim they “heal” or “protect” FDA will label that as a drug. Otherwise it can be classified as a cosmetic.
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This is an issue that the FDA really should consider changing as the labeling requirements often create the need for additional packaging that would not be required otherwise.
This does not much more than generate unnecessary waste in the form of boxes, cards, etc. that are simply thrown away and drives up costs to produce them when consumers could simply look up the LOI on their phones.
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@MarkBroussard while I partially agree it is also a question of access to information. Not everyone has a smartphone for instance. Then there is the change in formulations (let’s say removal of an allergen) which means it needs to be a batch specific lookup otherwise the website would not reflect the product composition.
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It’s a lot easier to change an LOI on a website than it is to print new labels or boxes if you make a change in formulation … think of the cost differential between those two options and as a bonus there is no waste generated.
Time to trade in those flip top phones!
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