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Selling it

Getting the label right the first time

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Everything that has to appear on a lip balm label is short and published. What costs money is that the label is bigger than the container and the sequence is usually run backwards.

The panel decides the tube

A 55 millimeter wrap has to carry an identity, a net weight, an INCI ingredient list and your name and address, and on the drug side a Drug Facts panel as well.

The ingredient list alone is longer than people expect once INCI names are used: Cera Alba, Butyrospermum Parkii and Simmondsia Chinensis take more room than beeswax, shea and jojoba.

So the label content has to be written before the tube is chosen, because on the drug side the tube size can decide whether the small-package format is available at all. This is the reverse of how the decision is normally made and it is the expensive part.

What forces a reprint

A reformulation that reorders the ingredient list by predominance. Two ingredients crossing over is invisible in the pot and is a new label.

A new supplier whose material carries a different INCI name for what you think of as the same thing.

A change of tube, which changes both the net weight and the label dimensions.

A move to or from a co-packer, which may change the responsible firm.

And crossing the cosmetic-or-drug line in either direction, which is not a reprint so much as a new label.

Whose name goes on it

The name and place of business of the manufacturer, packer or distributor. If somebody else fills for you, that does not move to them by default.

Settle it in the agreement before artwork. It is one line and it is expensive to revisit across ten thousand printed labels.

Order of operations

Regime, then formula, then label content, then tube, then artwork, then quantity.

Buy the first run of labels small and badly priced. The saving on a long run is real and it is smaller than one reformulation, and in the first year the formula will change.

References

US Food and Drug Administration. Summary of Cosmetics Labeling Requirements. fda.gov
Fair Packaging and Labeling Act, and INCI nomenclature for cosmetic ingredient declaration in descending order of predominance. fda.gov
21 CFR 201.66, Format and content requirements for OTC drug product labeling (the Drug Facts panel). Paragraph (d)(10) permits a modified format where the panel would otherwise require more than 60 percent of the total surface area available to bear labeling. ecfr.gov
Written from the federal regulation and FDA guidance named on each page, not from a laboratory or a legal practice. Whether a particular formula and a particular label make a cosmetic or a drug is a determination about your product, and this is not that determination.