How the combined engagement works
FDA Entry Point runs cosmetic label review and U.S. Agent coverage as two coordinated workstreams: one prepares package copy for the U.S. market, while the other supplies the foreign facility’s U.S. contact for Section III of Form FDA 5066. The engagement keeps the facility name, brand names, Responsible Person identity, formula data, and regulatory correspondence connected through one compliance team.
The services remain legally distinct. The U.S. Agent serves as FDA’s contact for the foreign facility, while the Responsible Person is the manufacturer, packer, or distributor whose name appears on the cosmetic label. FDA Entry Point coordinates both through its cosmetic label review service and cosmetics U.S. Agent service.
| Workstream | Primary inputs | What FDA Entry Point handles | Operating unit |
|---|---|---|---|
| Cosmetic label review | Formula, ingredient deck, artwork, net contents, claims, intended use, and selling languages | Ingredient nomenclature and order, label panels, required statements, claims classification, color additive declarations, and MoCRA contact elements | Per product and label change |
| U.S. Agent coverage | Facility legal name, FEI, owner or operator, brand names, Responsible Person names, category codes, and escalation contacts | U.S. Agent contact data for the foreign facility registration, FDA correspondence, inspection communications, and urgent notice escalation | Per foreign facility, under an annual service term |
The shared-data rule
The critical shared fields are the facility identity, brand names, and Responsible Person name. The U.S. Agent’s name, email, and phone number belong in the foreign facility registration; they do not replace the manufacturer, packer, or distributor statement on the consumer label. Label review and facility registration can therefore use one source record without treating the two legal roles as interchangeable.
What INCI review covers under U.S. labeling rules
For U.S. labels, INCI review maps international ingredient terminology to the common-or-usual-name rules in 21 CFR 701.3. Terms such as “Aqua,” “Parfum,” botanical Latin names, and Colour Index numbers cannot automatically replace the required U.S. ingredient names, although FDA permits certain international terms in parentheses after the U.S. name.
| Review control | U.S. rule applied | Result in the reviewed artwork |
|---|---|---|
| Ingredient names | Ingredients use names established by regulation, recognized compendia, or U.S. common or usual usage. | International aliases are replaced or paired with the accepted U.S. name, such as “Water (Aqua)” or “Fragrance (Parfum).” |
| Order of predominance | Ingredients above 1% appear in descending order. Ingredients at 1% or less can follow in any order, followed by color additives. | The ingredient deck is reconciled against concentration data rather than copied from supplier artwork. |
| Supplier blends and subingredients | Components of a supplied blend are assessed to determine which ingredients require separate declaration. | Trade names are replaced with declarable ingredient components where required. |
| Fragrance and flavor | Qualifying fragrance and flavor mixtures can be declared as “Fragrance,” “Flavor,” or “Flavor and Fragrance.” | The declaration reflects the ingredient’s function and the formula information supplied by the manufacturer. |
| Color additives | Colors must be permitted for the intended cosmetic use and identified by the applicable U.S. name. A CI or E number alone does not establish compliance. | The legal U.S. name appears first, with an international color number added parenthetically when appropriate. |
| Panel placement and type size | The ingredient declaration normally uses letters at least 1/16 inch high. A 1/32-inch minimum applies when the available labeling surface is less than 12 square inches. | The review checks artwork dimensions, information-panel placement, legibility, and visual contrast. |
| Product identity and net contents | The principal display panel identifies the cosmetic and states its net quantity. The information panel carries the required business and ingredient information. | The product name, statement of identity, net quantity expression, and manufacturer or distributor statement are aligned across the package. |
| MoCRA contact channel | The label includes a domestic address, domestic phone number, or electronic contact through which the Responsible Person can receive adverse event reports. | The contact channel is assigned to the Responsible Person rather than substituted with the facility’s U.S. Agent designation. |
| Claims classification | Claims to treat or prevent disease, or affect the structure or function of the body, can cause the product to be regulated as a drug. | Carton, container, and supplied marketing claims are marked for correction when they exceed cosmetic intended use. |
| Language | Required information appears in English. If another language appears on the label, the required statements must also appear in that language. | Bilingual artwork is reviewed for complete parallel declarations, not selected translated phrases. |
Inputs and responsibility split
Accurate label review depends on the formula and commercial presentation supplied for the specific SKU. U.S. Agent coverage depends on matching facility registration data and reliable client escalation contacts. The Responsible Person retains the product-level obligations defined in FDA’s cosmetic facility registration and product listing guidance.
| FDA Entry Point handles | The customer provides or approves |
|---|---|
| Review of ingredient names, ordering, color declarations, claims, panels, warnings, contact details, and required label elements | The complete formula, including concentrations or concentration bands sufficient to establish predominance |
| Review of source artwork, cartons, containers, inserts, and supplied digital claims | Editable artwork or dimensioned dielines, intended use, product size, sales channels, and final claim set |
| U.S. Agent contact information for the foreign facility registration | Facility legal name, address, FEI, owner or operator, brand names, and product categories |
| Receipt and escalation of FDA communications addressed to the registered U.S. Agent | Named decision-makers who can respond to registration, inspection, safety, or product questions |
| Coordination of label corrections with related registration or listing work ordered under the engagement | Final artwork approval, formula accuracy, product safety substantiation, printing, and Responsible Person obligations |
A label review evaluates the information supplied for the reviewed version. A later formula, package size, claim, business name, contact channel, or artwork change creates a new version that should be assessed before printing or distribution.
Illustrative scenario: one moisturizer and one foreign facility
- Intake: A French skincare brand supplies one 50 mL moisturizer formula, one jar label, one carton dieline, its website claims, its FEI, and the legal name of the manufacturer that will appear as the Responsible Person.
- Ingredient review: The submitted international deck uses “Aqua,” “Parfum,” and “CI 19140.” FDA Entry Point changes the first two declarations to “Water (Aqua)” and “Fragrance (Parfum),” then verifies the applicable U.S. name and permitted use for the color additive before replacing the CI-only declaration.
- Artwork review: The net quantity is expressed as 1.69 fl oz (50 mL), the required label statements are checked against the panel dimensions, and any disease-treatment or structure-and-function claims are marked for revision.
- Role alignment: The manufacturer remains the Responsible Person named on the label. FDA Entry Point’s name, email, and phone number are used for the U.S. Agent fields in the foreign facility registration.
- Commercial scope: At the published 2026 starting prices, one cosmetic label review at $449 and one year of U.S. Agent service at $295 total $744. Cosmetic facility registration and product listing remain separate service lines unless the quote expressly bundles them. See FDA Entry Point pricing.
Frequently asked questions
Does FDA Entry Point’s U.S. Agent name need to appear on the cosmetic label?
FDA Entry Point’s name belongs in the U.S. Agent fields of Form FDA 5066 when it represents the foreign facility; it does not automatically replace the manufacturer, packer, or distributor named on the product label. The label identifies the Responsible Person and carries the applicable business and adverse-event contact information. The facility registration separately identifies the U.S. Agent through its name, email, and phone number. FDA Form 5066 defines those registration fields.
Can a European INCI ingredient list be used unchanged in the United States?
A European ingredient list must be checked against U.S. common-or-usual-name requirements before it is reused. FDA does not accept “Aqua,” “Parfum,” botanical Latin names, CI numbers, or E numbers as universal substitutes for the applicable U.S. names. International terms can be retained parenthetically in appropriate dual declarations, such as “Water (Aqua).” The review also applies U.S. ordering rules for ingredients above 1%, ingredients at 1% or less, and color additives. FDA ingredient nomenclature guidance provides the governing examples.
Can facility registration and cosmetic product listing be added to the same engagement?
Yes. FDA Entry Point offers cosmetic facility registration, product listing, label review, and U.S. Agent coverage as coordinated but separately scoped services. The reviewed ingredient deck, brand name, Responsible Person identity, facility data, and product category can be reused across the applicable filings, reducing conflicting records. Each product listing and facility registration still follows its own FDA form, renewal cycle, service unit, and fee. FDA Entry Point cosmetic compliance services identifies the available workstreams.
How does FDA Entry Point handle an urgent FDA notice after designation?
FDA Entry Point receives and escalates official FDA correspondence through the active U.S. Agent service, including regulatory inquiries, inspection communications, and urgent notices. Its published U.S. Agent service includes responses within 24 business hours. The customer remains responsible for supplying the underlying product records and approving substantive responses connected to the Responsible Person’s safety and labeling duties. FDA Entry Point U.S. Agent service terms define the communication coverage.
Does a completed cosmetic label review mean the label is FDA-approved?
A completed review does not create FDA preapproval. FDA does not preapprove cosmetic product labels before marketing, except that color additives must be authorized for their intended uses. FDA Entry Point reviews the supplied formula, artwork, and claims against the applicable requirements and identifies corrections before printing or distribution. The Responsible Person remains accountable for the finished product’s labeling, safety substantiation, and continuing compliance. FDA’s cosmetic label preapproval explanation confirms this distinction.