How to label handmade lotion (FDA rules, step by step)
Lotions, creams and body butters are cosmetics — there is no “true soap” escape hatch here. That means the full FDA labeling stack applies to every jar you sell. Here it is, in the order it appears on a label.
Front panel (principal display panel)
- Identity — what it is: “Body Lotion”, “Hand Cream” (21 CFR 701.11);
- Net quantity — bottom 30%, parallel to the base, dual units: 4 fl oz (118 mL) for liquids, Net Wt 4 oz (113 g) for solids; minimum type size scales with label area (21 CFR 701.13).
Ingredient declaration (21 CFR 701.3)
- List INCI names in descending order of predominance — water first in most lotions (“Water”);
- Ingredients at 1% or less may be listed in any order after those above 1% — your preservative and vitamin E usually live here;
- Color additives may be listed last in any order;
- Fragrance blends may be declared simply as “Fragrance”;
- Blends must be broken out: “Emulsifying Wax NF” is not an INCI name — declare its components (e.g. Cetearyl Alcohol, Polysorbate 60). Same for preservative blends like Optiphen (Phenoxyethanol, Caprylyl Glycol);
- Letters at least 1/16″ (1/32″ allowed under 12 sq in of label space).
The warning nobody likes (21 CFR 740.10)
If a cosmetic's safety has not been adequately substantiated, the label must carry: “Warning—The safety of this product has not been determined.” Substantiation can rest on existing ingredient safety data (CIR reviews, supplier documentation) plus your own product assessment — document what you rely on.
Business line + MoCRA contact
Name and place of business (21 CFR 701.12), with “Distributed by…” if you don't manufacture. And since Dec 29, 2024: a US address, US phone, or website/email that can receive adverse-event reports (FD&C §609(a) — MoCRA). Small-business status does not exempt the label line.
Claims: stay cosmetic
“Moisturizes,” “softens,” “smooths” — cosmetic, fine. “Treats eczema,” “anti-inflammatory,” “repairs skin barrier,” SPF — drug claims; your lotion would need OTC drug labeling. Write for beauty, not therapy.
Do the whole label in 60 seconds
The Inkurate generator takes your recipe with percentages, orders the INCI list correctly (including the ≤1% group and blend break-outs), formats net contents, inserts required warnings and the MoCRA line — and gives you a dated, citation-backed compliance report.