Lip Balm Labeling Quandry

SoapyQueenBee · May 14, 2014

I'm full of questions, it seems!

I've been purchasing a very popular brand of natural lip balm for years, when I haven't had the time to make my own. I just noticed yesterday that there is nothing on the label but the company name. Their benefits & ingredients are listed on the box it's sold in, but shouldn't this information also be on the tube itself, as the customer generally doesn't carry/keep it in the box? Are they committing a labeling no-no, or have I misunderstood the regulations? :?:

pamielynn · May 14, 2014

I think it's proper to do it that way. I've seen lots of products with ingredients on the package, but not on the bottle/tube/jar itself.

Forsenuf · May 14, 2014

It's possible that the lip balm could fall under the small packages exception listed here (see 8.3.7):

http://www.hc-sc.gc.ca/cps-spc/pubs/indust/cosmetics-cosmetiques/index-eng.php#four

SoapyQueenBee · May 15, 2014

Thank you for the replies, and the link!

grayceworks · May 15, 2014

FDA says it can be on the outer packaging, or even off-product labeling for very small or direct-mail cosmetic items:

Prominence of Ingredient Declaration
Prominent and conspicuous to render it easy to be read and understood by ordinary individuals under normal conditions of purchase

Letter Height
1/16 inch
Exception:
If total available labeling surface area is less than 12 sq. in.
1/32 inch
Information panel
Firmly affixed tag, tape, or card

21 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.

Prominence: The declaration must appear with prominence and conspicuousness so that it is likely to be read and understood (read with ease) by ordinary individuals under normal conditions of purchase. The letters must not be obscured by design, vignettes, background or crowding.

Type Size: Not less than 1/16 inch in height. It may be not less than 1/32 inch in height if the total surface area available to bear labeling (which excludes bottom, shoulder, neck, flange, decorative or sculptured surfaces) is less than 12 square inches.

The type size consisting of upper and lower case letters is determined by the height of the lower case letter "o".