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Lip care
All Containers›Shop by use case›Lip care›Tools and directories›Everything that has to be on the labelShop all lip care →
Tools and directories

Everything that has to be on the label

By Dwight Davis, Founder

Updated

On this page5

Work down this before ordering a print run. Which of the two lists applies to you was decided by what you say about the product.

Work out which list applies

Any claim to protect, relieve, treat or prevent anything about the lip puts you on the second list. So does any SPF claim, and so does a monograph active at a monograph level.

Everything else is the first list.

The cosmetic list

1 · Identity. What it is, on the principal display panel. "Lip balm", "lip butter", "lip conditioner". Note that "lip balm" is also a permitted statement of identity for a drug product, so it is doing double duty.

2 · Net quantity of contents. A net weight, in the bottom thirty percent of the principal display panel, with metric alongside. Established by filling and weighing, not from the tube's stated volume.

3 · Ingredients, by INCI name, in descending order of predominance, with color additives conventionally at the end.

4 · Name and place of business of the manufacturer, packer or distributor. A street address unless the firm is listed in a current directory.

5 · Warnings, where the product needs one to be used safely.

And not required but worth adding: a batch code, which is what makes a problem traceable and a recall survivable.

The drug list, in addition

Statement of identity from the permitted set: "Skin protectant", "lip protectant" or "lip balm".

Drug Facts panel in the 201.66 format: Active ingredient with its purpose, Purpose, Uses, Warnings, Directions, Other information, Inactive ingredients alphabetically.

The Uses wording as written in 347.50, taking only the marked options. Not a paraphrase.

Everything on the cosmetic list still applies.

Fitting it on a tube

Lay the panel out before choosing the tube. If the Drug Facts would need more than 60 percent of the total surface area available to bear labeling, the modified small-package format is available.

If it still will not fit, the answers are a bigger tube, a two-panel or extended-content label, or a carton, and all three are container decisions driven by the label, which is the reverse of the usual order.

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 347.50, Labeling of skin protectant drug products. Statement of identity is "Skin protectant", "lip protectant" or "lip balm"; the indication for a lip protectant is the prescribed phrase "temporarily protects and helps relieve chapped or cracked lips", with defined optional additions. ecfr.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.