Labelling cosmetics in the US: a worked lip balm label and the MoCRA obligations

Every required element on a 4.25 g lip balm label, then the MoCRA obligations with dates and status, the small business exemption and its exclusions.

Cosmetic labelling in the United States is less demanding than most makers fear and more demanding than most makers do. The core rules have been stable since the Fair Packaging and Labeling Act and 21 CFR 701, and they fit on one side of a page. What changed is everything around the label: the Modernization of Cosmetics Regulation Act of 2022, signed on 29 December 2022, added registration, listing, safety substantiation, adverse event reporting and a new label element, and it is still being rolled out.

The anatomy of a label, worked on a 4.25 g lip balm

Take the standard twist-up tube, nominal fill 0.15 oz or 4.25 g. The wrap label on a round 16.5 mm tube is roughly 52 mm around and 45 mm tall, about 23 cm2 or 3.6 square inches of printable surface. For a cylinder the principal display panel is 40 percent of height times circumference, so the "front" is about 1.4 square inches. Every required element still has to fit somewhere on the package.

Two details specific to very small packages are worth knowing. Under 12 square inches of surface, the smaller ingredient type size is allowed, and for products sold from a display unit the ingredient declaration may sit in labelling that accompanies the product rather than on the tube. The FDA labelling guide also notes an exemption from the net quantity statement below a quarter of an avoirdupois ounce (7.09 g) where the product is on a display card or in a labelled outer container. A 4.25 g tube is inside that limit, but declare the weight anyway.

Ingredient declaration: the rules that trip people up

Ingredients are declared in descending order of predominance. Those above one percent must be in order; those at one percent or less may follow in any order, and colour additives may come after the rest in any order. Products in a shade range may use a "may contain" or "+/-" list of colourants. Trade secret ingredients accepted as exempt may be replaced by "and other ingredients" at the end, which no small maker will ever use, because the exemption has to be granted in advance under 21 CFR 720.8. Incidental ingredients present at insignificant levels with no technical effect do not need declaring.

For an anhydrous product the list is short and unusually honest, because a balm has very little that belongs below one percent. Flavour and sweetener declarations are covered in more detail under lip balm flavour and sweeteners, and if you use essential oils, remember that they are declared by their INCI names, not as "essential oil blend": see essential oils in balms. A buyer's guide to reading the finished result is in reading a balm label.

MoCRA obligations, with dates and current status

MoCRA created duties that sit behind the label rather than on it. The table below is the position as at September 2026, with two of the rulemakings Congress ordered overdue.

Two things there are easy to misread. The statutory deadlines never moved: in November 2023 the FDA deferred enforcement of registration and listing to 1 July 2024, which is a compliance policy, not an extension. And the overdue rulemakings suspend nothing already in force. Scale, for context: the FDA reported 16,398 active facility registrations and 1,298,361 active product listings as at 30 June 2026. This is not a dormant regime.

Two adjacent items are worth a line. The proposed talc testing rule was withdrawn on 28 November 2025. And the FDA's PFAS report of December 2025 found 51 PFAS across 1,744 formulations, 0.41 percent of listed products, with 19 of the top 25 unassessable for want of toxicological data. There is no federal PFAS rule, though several states have their own.

The small business exemption, precisely

Section 612 of the Act, at 21 U.S.C. 364h, says that responsible persons and facility owners "whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation" are small businesses and are "not subject to the requirements of section 364b or 364c". Those two sections are good manufacturing practice and registration and listing. Nothing else is exempted.

The exclusions matter more than the threshold, because they are absolute. Make or process any of these four and the exemption is gone whatever your revenue.

Two practical consequences follow. The FDA has published no inflation-adjusted dollar figure and issues no exemption certificates, so nobody confirms your status: you work it out from your own sales records, write down the reasoning and the date, and keep it with the safety file. And lip balms, body balms and salves normally qualify on the product side, so the only live question for most makers is the under-eye case above.

Records, and what "adequate substantiation" looks like for a balm

Safety substantiation is not a certificate you buy. It is a file you keep, and for a simple anhydrous product a careful maker can assemble it honestly. A workable file per formula holds: the formula in weight percent totalling 100; a supplier specification for every raw material; the safety basis for each ingredient, typically the Cosmetic Ingredient Review conclusion; the microbiological reasoning for a water-free product; stability observations from shelf life testing; the finished label; and a dated, signed conclusion.

Adverse event records run six years, or three for a qualifying small business, and a serious adverse event must be reported within 15 business days with the retail label attached. So you need one log, kept from day one, recording every complaint with date, batch, contact details and outcome. This is where voluntary batch coding stops being tidiness, which is why batch scaling and sourcing records belong to the same paperwork habit.

Warnings and the claim boundary

Part 740 requires a warning whenever one is necessary or appropriate to prevent a health hazard, in bold type at least 1/16 inch tall on a contrasting background. Section 740.10 adds a consequence for skipping your homework: a product whose safety has not been adequately substantiated must bear "Warning: The safety of this product has not been determined". That is the label of last resort.

Everything on the label also has to stay inside the cosmetic category. The moment a lip balm carries an SPF number or says it treats anything, it is a drug and needs a Drug Facts panel instead of an ingredient declaration. That boundary is set out in full under cosmetic versus drug claims, and the specific case of sun protection under SPF in lip balm.

A compliance checklist

What to do next

Print a proof and measure it. Almost every non-compliant handmade label fails on something physical rather than legal: type below the minimum height, the net quantity crammed into a corner, an ingredient list cut to fit the artwork. Choose the pack first and the label second, which is the argument in the packaging guide, and the reason tube choice belongs in the same decision as filling lip balm tubes.

Then decide deliberately whether you are relying on the small business exemption. It costs nothing to claim and it is fragile: one eye-area product, or one good year, and it disappears. Registration and listing are free and take an afternoon, so a maker approaching the threshold often does it early rather than track the arithmetic. If you also sell across the Atlantic, selling balms in the UK and EU is where that starts. Do not copy a label off a competitor's tube: there is no way to tell from the outside whether they got it right. Start from your own formula and work outwards.

Reviewed and updated 6 September 2026. Spotted an error? Tell us and we will fix and log it.