What certificates does a scalp care serum need to enter the US?

For a scalp care serum, 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 scalp care serum is sold as a cosmetic scalp treatment, ask for the manufacturing facility's FDA registration number.

If your serum has a concentrated ingredient formula, request the ingredient artwork showing the names and their order.

If your serum will be bottled for retail, ask for the manufacturer or distributor details and net contents artwork.

If your serum has your business named on its label, keep the safety evidence supporting the finished scalp formula.

If your serum will be sold in states restricting cosmetic PFAS, ask your supplier about PFAS in the scalp treatment formula.

If your serum has no applicable listing exemption, confirm that the business named on its label handles the cosmetic product listing for that scalp 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.