Cosmetic or drug

The Drug Facts panel

Updated October 2026

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What it is The headings, in order The format rules are real rules It replaces nothing References

If the product is a drug, the label carries a Drug Facts panel, and the panel is specified down to type size.

What it is

A standardized block, set out in 21 CFR 201.66, that every OTC drug carries so a consumer can read any two products the same way. Headings in a fixed order, a fixed typeface treatment and a rule structure that is part of the requirement rather than a design convention.

The headings, in order

Active ingredient, with the purpose alongside it.

Purpose: for a lip protectant, "skin protectant".

Uses, in the prescribed wording.

Warnings, including when to stop use and ask a doctor, and keep out of reach of children.

Directions.

Other information, where required.

Inactive ingredients, alphabetically, note the contrast with a cosmetic, where the whole list runs in descending order of predominance under INCI.

And the name and address of the manufacturer, packer or distributor.

The format rules are real rules

Minimum type sizes, minimum leading, bullets, a box or comparable enclosure, and a specified order. They are enforceable requirements and not a template you may improve on.

The practical effect is that the panel is large. On a standard lip balm tube it is the dominant element of the label, which is what the small-package provision exists to address.

It replaces nothing

The Drug Facts panel sits alongside the ordinary labeling obligations rather than instead of them: the identity, the net quantity, your name and address.

A product that is a drug AND has cosmetic attributes, a tinted, flavored lip protectant, carries the drug labeling and the cosmetic ingredient declaration, which is where the surface area problem becomes acute.

References

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

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

US Food and Drug Administration. Summary of Cosmetics Labeling Requirements. fda.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.