Lip balm label requirements (US, 2026)
Lip balm is the product most makers get wrong, for two reasons: the label is tiny, and lips are the one body part with their own colorant law. Here is what a handmade lip balm sold in the US actually needs.
1. A plain lip balm is a cosmetic — full FDA labeling applies
A balm that softens, smooths or beautifies the lips is a cosmetic under the FD&C Act. There is no "true soap"-style exemption for balms: the complete cosmetic label is required — identity statement, net quantity, full ingredient declaration, your business name and address, and the MoCRA contact line (each covered below).
2. The claims trap is sharpest on lip products
Watch your wording, because intended use is decided by what the label says:
- “Moisturizes,” “softens,” “smooths” — cosmetic. Fine.
- “Heals chapped lips,” “medicated,” “treats cold sores” — that is a drug claim; the product would need to follow OTC drug labeling, a different regime entirely.
- SPF / “sun protection” — SPF lip balms are drugs (sunscreens), full stop. Don't put an SPF number on a cosmetic balm.
3. Colorants: what's illegal ON LIPS specifically
Anything added to impart color must be an FDA-approved color additive (21 CFR Part 73 and the FD&C certified colors), and several additives approved for other cosmetics are not permitted in lip products:
- Ultramarines (those gorgeous blues/violets) — not allowed on lips;
- Chromium oxide greens / chromium hydroxide green — not allowed on lips;
- Iron oxides, titanium dioxide, zinc oxide, mica, carmine — permitted in lip products;
- Botanical powders (beetroot, turmeric, hibiscus) — not approved color additives for any cosmetic use, lips included.
This is the single most common compliance error in handmade tinted balms — a mica blend whose listed components include ultramarines or chromium greens cannot legally go in a lip product even though the same mica is fine in soap.
4. The ingredient list on a tiny label
- Ingredients go in descending order of predominance; ingredients at 1% or less may follow in any order; color additives last (21 CFR 701.3);
- Use INCI names — Butyrospermum Parkii (Shea) Butter, not “shea butter” alone;
- Flavor oils may be declared simply as “Flavor” (lip products are flavored, not fragranced — though either word works if truthful);
- Minimum letter height is 1/16", but on packages with under 12 square inches of labeling surface — every lip balm tube — 1/32" is permitted (21 CFR 701.3).
5. Net quantity, identity, and your name
- Identity (“lip balm”) on the front panel;
- Net weight in dual units, e.g. Net Wt 0.15 oz (4.25 g), in the bottom 30% of the principal display panel, type size scaled to label area (21 CFR 701.13);
- Business name and place of business; use “Distributed by…” if you don't manufacture it yourself (21 CFR 701.12).
6. The MoCRA contact line (since Dec 29, 2024)
Every cosmetic label must now carry a US address, US phone number, or electronic contact through which adverse-event reports can reach you (FD&C Act §609(a)). The small-business exemption does not waive this label requirement. On a tube this is usually your website or email — it must actually be monitored.
Generate it instead of memorizing it
The Inkurate generator applies every rule above to your recipe — INCI ordering, the lip-colorant check, flavor declaration, net-contents formatting, the MoCRA line — and cites the regulation for each element. The preview is free.