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U.S. Cosmetic Ingredient Review

A clause-by-clause check of your formula under the FDA framework: prohibited and restricted ingredients, color additive rules, and standardized nomenclature (INCI). Risk ingredients are flagged, laying the groundwork for label finalization and product listing.

RegulatorU.S. FDA
PrerequisiteComplete formula with concentrations
Timeline~1-2 weeks
DeliverableIngredient review report
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What this service is

The U.S. regulates cosmetic ingredients through lists: the FD&C Act and 21 CFR Part 700 prohibit or restrict specific ingredients, and color additives must be FDA-approved, with certain batches requiring batch certification.

Ingredient review is the upstream step of label review and product listing: whether an ingredient may be used and how it must be named determines the content of the label ingredient declaration and the MoCRA listing.

FD&C Act21 CFR Part 70021 CFR Parts 73 & 74

Who needs it

Cosmetic companies planning U.S. exports that need to confirm formula compliance
Brands whose formulas contain color additives, sunscreen agents, or other specially regulated ingredients
Companies that need to lock the ingredient basis before label review or listing filings

Prerequisites and sequence

  • Provide the complete formula with concentrations or concentration order; a preliminary check is possible with only the label ingredient list.
  • If the product also carries drug-type claims such as sun protection, the regulatory pathway changes and must be assessed separately.

Who holds regulatory responsibility

Ingredient safety and compliance rest with the manufacturer and the responsible person. Our opinion is based on public regulations and FDA documents; formula decisions remain with you.

Materials we need from you

Complete formula (with concentrations or concentration order)
INCI names or supplier documentation for each ingredient
Details of color additives used and their intended purpose
Directions for use and application area

Process

  1. 01

    Screen each ingredient against FDA prohibited and restricted lists

  2. 02

    Check whether color additives fall within FDA approval and certification requirements

  3. 03

    Verify ingredient nomenclature against accepted naming systems (INCI and others recognized by FDA)

  4. 04

    Flag risk ingredients with recommended actions (substitution, restriction, supporting evidence)

  5. 05

    Issue the ingredient review report as the basis for label finalization and listing filings

Deliverables

Ingredient compliance review report (per-ingredient conclusions with regulatory basis)
Risk ingredient list with recommended actions
Standardized nomenclature cross-reference table

Timeline

A single formula is typically reviewed within about 1-2 weeks once documents are complete; complex formulas or missing raw-material data extend the schedule.

Scope

What we provide

  • Prohibited/restricted ingredient screening
  • Color additive compliance check
  • Nomenclature standardization check
  • Risk flagging and substitution direction

What is not included

  • Formula redevelopment or sampling
  • Supplier qualification audits
  • In-depth toxicological evaluation of ingredients (covered by the TRA service)

What usually follows

Cosmetic Label ReviewMoCRA Product ListingToxicological Risk Assessment (TRA)

Common pitfalls

Assuming an ingredient allowed at home is allowed in the U.S.Prohibited and restricted lists differ across jurisdictions, and some ingredients are managed very differently. Each formula must be checked against the U.S. lists specifically.
Treating ingredient review as a TRAIngredient review checks regulatory permissibility (may it be used, under what name); a TRA evaluates toxicological safety at actual use levels. An ingredient review alone does not complete your safety substantiation.
Overlooking color additive rulesColor additives must be FDA-approved, and certain batches require batch certification. Formulas containing color additives need their approval status and permitted uses confirmed separately.

Pricing

Pricing depends on your product, quantity, and target market. Submit your product details and we will come back with a defined scope and quote.

Request a quote

FAQ

Does FDA approve cosmetic ingredients?

Except for color additives, FDA does not approve individual cosmetic ingredients before marketing, but it defines prohibited and restricted lists and holds companies responsible for ingredient safety. The review screens your formula against these hard rules.

If an ingredient is allowed at home, is it allowed in the U.S.?

Not necessarily. Prohibited and restricted lists differ across jurisdictions, and some ingredients are managed very differently. Each formula must be checked against the U.S. lists specifically.

What is the difference between ingredient review and TRA?

Ingredient review checks regulatory permissibility (may it be used, under what name); TRA evaluates toxicological safety (is it safe at the actual use level). The two are often used together.

Related services

Cosmetic Label ReviewA clause-by-clause review of your existing label against FDA cosmetic labeling rules: claims wording, ingredient declaration, mandatory statements, type size and layout. You receive an action-point list and a suggested corrected draft, reducing misbranding risk.TRAA qualified assessor evaluates your formula: reviewing the toxicological profile of each ingredient and calculating margins of safety against expected exposure, producing a report that supports the safety substantiation MoCRA requires.MoCRA Product ListingMoCRA requires the responsible person named on the label to list every cosmetic marketed in the U.S. with FDA, including ingredient information, and update the listing annually. We file each product on your behalf.

Disclaimer

This service is a compliance review based on public regulations. It is not legal advice or a final certification of product safety.