Classification first. It decides what the label has to say, and the label decides how much room you need on the container.
One: decide what you are claiming
Write the sentence you want to put on the front of the bottle before you write the formula. If that sentence is about conditioning, softening, scenting or appearance, you are making a cosmetic. If it is about growth, repair, treatment or anything the body does, you are not.
Two: check the ingredients against the prohibited list
A cosmetic containing a prohibited or restricted ingredient is adulterated no matter how carefully it is labeled. That check is a reading of a short list, and it costs nothing to do before you buy forty pounds of anything.
Three: substantiate the safety, and keep the record
Under MoCRA the responsible person maintains records supporting adequate safety substantiation, derived from scientifically robust methods. The alternative is the 740.10 warning on the front panel, which is a sentence no retail buyer wants on a shelf.
Four: write the label from the regulations
The ingredient declaration in descending order of predominance. The name and street address of the responsible firm. The net quantity, placed and sized as 701.13 requires. Any warning in bold on a contrasting background, 1/16 inch minimum.
Five: now choose the container
Because now you know how much label area you need, and a 10 mL bottle with a full ingredient declaration, an address and a net quantity is a genuinely hard layout. Choosing the bottle first and discovering this afterwards is how a finished artwork becomes unprintable.
Six: register and list, unless you are exempt
MoCRA requires facility registration renewed every two years and a product listing by the responsible person, updated annually. Certain small businesses are exempt, but not for products that contact mucous membranes. Read that carve-out against your own range rather than against the category.
The order is not a preference
Every step above constrains the one after it. Done in this order each decision is made once. Done in any other order, the common outcome is a label that will not fit the bottle you already bought a case of.
References
21 CFR 700.11 through 700.35, the prohibited and restricted ingredients. A cosmetic containing one of these is adulterated regardless of how it is labeled.
law.cornell.eduFDA,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Facility registration renewed every two years; product listing by the responsible person with annual updates; records supporting adequate safety substantiation derived from scientifically robust methods; serious adverse events reported within 15 business days, with new medical information received within one year reported within a further 15 business days. Certain small businesses are exempt from GMP, registration and listing, except for products that contact mucous membranes, are injected, are intended for internal use, or alter appearance for more than 24 hours.
fda.gov21 CFR 701.3, the cosmetic ingredient declaration: the label "shall bear a declaration of the name of each ingredient in descending order of predominance", with the alternative grouping at (f) allowing ingredients at not more than 1 percent, and color additives, to be listed without respect to order; and at (b) a requirement that the declaration appear with such prominence "as to render it likely to be read and understood by ordinary individuals under normal conditions of purchase".
law.cornell.edu21 CFR 701.13, net quantity of contents. It is declared on the principal display panel "within the bottom 30 percent of the area of the label panel in line generally parallel to the base on which the package rests", a placement waived where that panel is 5 square inches or less; weight in avoirdupois pound and ounce, fluid measure in US gallon and its quart, pint and fluid ounce subdivisions; type not less than 1/16 inch for a panel of 5 square inches or less and 1/8 inch above that to 25 square inches.
law.cornell.edu21 CFR 740.10, the warning for a cosmetic whose safety has not been adequately substantiated, which must appear on the principal display panel: "Warning--The safety of this product has not been determined."
law.cornell.edu 