Cosmetic or drug

The words you are allowed to use

Updated October 2026

On this page5

The wording is prescribed What you may call it The indication, with its options Why paraphrasing is the trap References

An OTC monograph is not permission to describe the benefit in your own words. It sets the words.

The wording is prescribed

347.50 gives the statement of identity, the indication and the directions, with the optional additions marked. Departing from it does not make the label more informative; it makes the product misbranded.

This is the opposite of how a cosmetic label works, where you write the copy and stay inside the truthful-and-not-misleading boundary. Here the copy is supplied.

What you may call it

For a product formulated as a lip protectant, the statement of identity is "Skin protectant", "lip protectant" or "lip balm", optionally followed by the dosage form.

Which is worth sitting with: "lip balm" is not an ordinary descriptive phrase in this context. It is one of three permitted statements of identity for a drug product, and using it on a product making protective claims is using the monograph's own language.

The indication, with its options

Under the heading Uses, the label states, for a product formulated as a lip protectant:

(optional: "helps prevent and") "temporarily protects" (optional: "and helps relieve") (optional: "chafed,") "chapped or cracked lips".

It may be followed by: "helps" (optional: "prevent and") "protect from the drying effects of wind and cold weather".

The optional parts are genuinely optional and the rest is not. Each statement is bulleted if both are used.

Why paraphrasing is the trap

"Soothes and heals chapped lips" is the sentence a maker writes. It is not in the monograph, "heals" is a therapeutic claim beyond the indication, and the whole label now sits outside the conditions under which the product was generally recognized as safe and effective.

The discipline is unfamiliar and it is the cheapest part of this to get right: copy the wording, take the options you want, and put the personality in the brand rather than in the Uses section.

References

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 347.3, Definitions. "Lip protectant drug product. A drug product that temporarily prevents dryness and helps relieve chapping of the exposed surfaces of the lips; traditionally called ‘lip balm.’" ecfr.gov

21 CFR 347.10, Skin protectant active ingredients. A closed list at fixed concentrations, including allantoin 0.5–2%, cocoa butter 50–100%, dimethicone 1–30%, glycerin 20–45%, hard fat 50–100%, lanolin 12.5–50%, mineral oil 50–100%, petrolatum and white petrolatum 30–100%. 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.