What certificates does a refillable body lotion bar need to enter the US?

For a refillable body lotion bar, the things you must have are: FDA cosmetic facility registration; Ingredient list; Country of origin marking.

The things you must have

• FDA cosmetic facility registration

  Your factory registers with FDA; you'll ask for its facility registration number.

• Ingredient list

  Your factory lists ingredients on the label; you'll ask for artwork before printing.

• Country of origin marking

  Your factory supplies English markings.

How many requirements are in the checklist?

The full checklist has 7 items: 3 apply to every product in this category, 4 apply only in some situations, and 0 are notes rather than steps.

Laboratory tests and their conditions

The regulations do not specify tests. Keep your own safety evidence. If child-resistant packaging is required, test the packaging under 16 CFR 1700.20.

This checklist doesn't list any mandatory laboratory tests for this product.

What to look at for this product

If your refillable body lotion bar is sold for cosmetic skin care, ask your factory for the facility registration number covering its manufacturing site.

If your bar uses several moisturizing ingredients, request ingredient artwork showing their names in the required order.

If your bar will be supplied as a retail refill, check the net contents and responsible business details for that refill packaging.

If your bar has your business named on its label, retain safety substantiation for the finished moisturizing formula.

If your bar will sell where cosmetic PFAS restrictions apply, ask your factory about PFAS in the formula used for the refill.

If your bar is supplied as a branded refill, confirm who handles its cosmetic listing and whether a listing exemption applies to that moisturizing formula.

Labels and state rules

List and name ingredients in the order required by 701.3; include the manufacturer's or distributor's name and address, net contents and US contact information for adverse event reports.

Proposition 65; PFAS rules in Minnesota, Maine, Vermont and Colorado

How this page was prepared

This page matches a product name to the rule library. We haven't inspected the physical product, and this isn't legal advice.