MoCRA Product Listing

MoCRA Product Listing — <a href='https://www.fda.gov' title='FDA' >FDA</a> Cosmetic Product Listing Services | <a href='https://www.fda.gov' title='FDA' >FDA</a> Registration Assistance
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MOCRA COSMETIC FACILITY REGISTRATION

MoCRA Cosmetic
Product Listing Services

MoCRA Cosmetic Product Listing is the FDA-mandated electronic submission of detailed product-level information — including ingredients, labeling, category, and the responsible person — for every cosmetic sold in the United States. It is required by the Modernization of Cosmetics Regulation Act of 2022, codified under 21 U.S.C. § 364c, and is filed using FDA Form 5067 through the FDA Cosmetics Direct portal. The listing gives the FDA traceable safety and ingredient data on every cosmetic product entering U.S. commerce — supporting recall, adverse-event, and import oversight. Failure to file makes a product misbranded under section 605 of the FD&C Act, exposing the responsible person to warning letters, import refusal, and removal from major retail platforms.

MoCRA Product Listing — Quick Facts
Who Needs It Every responsible person marketing cosmetics in the U.S. — domestic or foreign
Governing Regulation MoCRA 2022 · 21 U.S.C. § 364c · FD&C Act § 607
FDA Form Required FDA Form 5067 — filed electronically via Cosmetics Direct
Ingredient Format Full INCI list, including fragrance & flavor disclosure
Confirmation Issued FDA Cosmetic Product Listing Number (CPLN)
Update Cycle Within 60 days of any material change · annual review
U.S. Agent Required for all foreign responsible persons
Service Fee $199 USD per product — preparation & submission included
Penalty for Non-Compliance Product deemed misbranded under FD&C Act § 605 · warning letters · import refusal · platform delisting (Amazon, Shopify, Walmart)

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) requires all cosmetic manufacturers and processors to register with the FDA, submit product listings, and renew their registration annually. FDA Registration Assistance handles the complete MoCRA compliance process for domestic and foreign cosmetic companies — accurately and on time.

$199 USD — Per Product MoCRA Product Listing — Preparation & Submission Included
1,000+
Clients Served
135+
Countries Served
15+
Years Experience
100%
On-Time Registrations
Foreign & Domestic Products
MoCRA Product Listing
End-To-End Listing Support
MoCRA & FDA Compliant

What Is MoCRA Product Listing & Who Must Comply?

Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), any company that markets cosmetic products in the United States must electronically submit Cosmetic Product Listings to the FDA. Product listings give the FDA detailed information about each cosmetic product — including its name, category, ingredients, labeling, and responsible person — enabling improved safety oversight and traceability.

MoCRA product listings apply to both domestic and foreign cosmetic products sold in the U.S. market. Listings must be submitted when a product is first marketed, and updated whenever there are changes to formulation, labeling, or responsible person information. Failure to list products may result in FDA regulatory enforcement action.

  • All cosmetic products marketed in the United States
  • Foreign and domestic brands and responsible persons
  • New products must be listed when first marketed in the U.S.
  • Listings must be updated for any formulation or labeling changes
  • Submitted electronically via FDA Form 5067
  • Coordinated with MoCRA facility registration (Form FDA 5066)

Our MoCRA Product Listing Services

FDA Registration Assistance handles every aspect of your MoCRA cosmetic product listing — from gathering product and ingredient information to preparing, submitting, and maintaining your listings with the FDA, end-to-end.

Product Listing Preparation & Submission

FDA Registration Assistance prepares and submits your MoCRA cosmetic product listings using FDA Form 5067 — ensuring all required product information, ingredient data, and responsible person details are accurately filed with the FDA.

Ingredient & Label Review

FDA Registration Assistance reviews your product ingredient lists and labeling information to ensure they meet FDA MoCRA requirements — identifying any compliance gaps before your product listing is submitted to the FDA.

Listing Updates & Amendments

FDA Registration Assistance manages ongoing updates to your MoCRA product listings — ensuring any changes to formulation, labeling, or responsible person information are promptly reflected in your FDA records as required.

Ongoing Compliance Support

FDA Registration Assistance provides year-round MoCRA product listing compliance support — coordinating your listings with facility registration, monitoring regulatory changes, and ensuring your cosmetic products remain fully compliant at all times.

Trusted MoCRA Product Listing Specialists

Helping domestic and foreign cosmetic companies submit accurate, complete, and timely MoCRA product listings — without the regulatory complexity.

1,000+
Clients Served
Cosmetic brands and responsible persons supported worldwide
135+
Countries Served
Countries served — foreign and domestic cosmetic companies
100%
On-Time Submissions
MoCRA product listings submitted accurately and on time
15+
Years Experience
FDA cosmetic & MoCRA product listing expertise since 2013

How Our MoCRA Product Listing Service Works

A simple, guided four-step process — we handle every step of your FDA MoCRA cosmetic product listing, from data collection to submission and ongoing updates.

1

Submit Your Product Details

Provide your product names, categories, ingredient lists, labeling, and responsible person information. We guide you through exactly what the FDA requires for each product listing.

2

Listing Prepared & Reviewed

Our regulatory specialists prepare your complete MoCRA product listing using FDA Form 5067 — reviewing ingredient data, labeling details, and facility registration references for accuracy.

3

Submitted to the FDA

We electronically submit your cosmetic product listings to the FDA on your behalf — ensuring timely, accurate, and fully compliant submissions that meet all MoCRA requirements.

4

Listings Maintained & Updated

We monitor your product listings and manage any required updates — including formulation changes, labeling amendments, or responsible person updates — keeping your FDA records current annually.

Core Responsibilities Under MoCRA

A compliant responsible person — and the service that supports them — must perform each of the following duties under MoCRA. These are not optional; they are required by 21 U.S.C. § 364c–364h.

01

File FDA Form 5067 for Every Product

Submit a complete electronic cosmetic product listing through FDA Cosmetics Direct for every product marketed in the U.S. — including grouped variants where formulation is identical.

02

Maintain Full Ingredient Disclosure

Provide the complete INCI ingredient list — including any fragrance or flavor breakdowns that the FDA may request under 21 U.S.C. § 364c(b)(2) for safety review.

03

Link Listing to a Registered Facility

Reference a valid FDA facility registration number (Form FDA 5066) on every product listing. Listings cannot be filed against an unregistered manufacturing or processing facility.

04

Designate a U.S. Agent (Foreign Filers)

Foreign responsible persons must designate a U.S. Agent with a verifiable physical U.S. address under 21 CFR 207.69 to receive FDA communications and serve as the FDA's local contact.

05

Update Listings Within 60 Days

File an amendment within 60 days of any material change — ingredient substitution, label revision, product name change, or change of responsible person — to keep the FDA record current.

06

Report Serious Adverse Events

Report any serious adverse event to the FDA within 15 business days under MoCRA section 605, and retain associated records for at least six years.

07

Maintain Safety Substantiation Records

Hold adequate scientific evidence supporting the safety of every cosmetic product under MoCRA section 608 and produce it on FDA request during inspection.

08

Confirm Annually & Renew on Time

Confirm the accuracy of all listings on FDA's required annual review cycle and renew the underlying facility registration each year to keep listings active and valid.

MoCRA Product Listing vs. MoCRA Facility Registration

These two MoCRA requirements are commonly confused — but they are separate filings that serve different purposes. Most cosmetic businesses must complete both.

CriteriaMoCRA Product ListingMoCRA Facility Registration
Who Designates ItThe responsible person (brand owner, packer, or distributor on label)The owner or operator of the cosmetic manufacturing or processing facility
Who It RepresentsIndividual cosmetic products in U.S. commerceThe physical facility where cosmetics are manufactured or processed
Required ByMoCRA § 607 — once per product, updated on changesMoCRA § 607 — every facility, renewed annually
Governing Regulation21 U.S.C. § 364c · FDA Form 506721 U.S.C. § 364c · FDA Form 5066
Primary FunctionDisclose ingredients, labeling, and responsible person for each productIdentify the physical site, owner, and U.S. Agent of the manufacturing facility
Required ForEvery cosmetic product (SKU/formulation) marketed in the U.S.Every facility that manufactures or processes cosmetics for the U.S. market

These are separate roles — most businesses need both. Facility registration tells the FDA where your cosmetics are made; product listing tells the FDA what you make and sell. A registered facility with no product listings is non-compliant — and product listings cannot be filed without a valid facility registration number to attach to them. Private-label brands that don't operate their own facility still need product listings (filed against their contract manufacturer's registered facility), and contract manufacturers still need facility registration even if they don't own the brands they produce. FDA Registration Assistance routinely handles both filings together to ensure they reference each other correctly and remain in sync through every renewal.

Filing Yourself vs. Using FDA Registration Assistance

Cosmetics Direct is technically open to the public — but the FDA assumes the filer knows MoCRA, INCI conventions, and label law. Here's how the two paths compare.

CriteriaDIY Filing Recommended FDA Registration Assistance
Cost$0 government fee — but adds your time, errors, and rework
AvailabilityYou learn the portal yourself; FDA does not offer filing support
Domain-Specific SupportNo INCI review, no label compliance check, no responsible person guidance
Risk of FailureHigh — rejected filings, misclassified products, missing fragrance disclosures
Confirmation & HandlingSelf-monitored; you must save your own CPLN and submission receipts
Renewal & Update TrackingYou must remember every 60-day amendment window and annual confirmation

Why most brands choose a professional service. The FDA's portal is free, but a rejected or misfiled product listing can stall import clearance, trigger platform delistings on Amazon or Shopify, and expose the responsible person to misbranding action. Dedicated professional filing removes the regulatory uncertainty, ensures every ingredient, label, and facility reference is correct on the first submission, and tracks every future amendment so the listing never lapses.

Free / Informal Filing vs. FDA Registration Assistance

Some brands ask a friend, an overseas freelancer, or an unrelated party to file their MoCRA product listing for free. Here is the honest comparison.

CriteriaFree / Informal Option Recommended FDA Registration Assistance
Government Fee$0 — FDA charges no fee to file FDA Form 5067
ProsNo professional cost; quick if the filer happens to be experienced
ConsNo accountability, no label review, no INCI verification, no renewal tracking — rejected filings are common
Best ForHobby brands not actually selling in U.S. commerce

The real risk of the free/informal route: a rejected or inaccurate filing leaves the responsible person — usually you, the brand owner — exposed to FDA misbranding action, import refusal, and platform delisting. The FDA does not blame the friend who filed. The $199 per-product professional fee buys verified ingredient handling, label compliance review, and a tracked, defensible filing history.

MoCRA & Cosmetic Regulatory Terms You'll Encounter

A plain-language glossary of the key technical terms used throughout the MoCRA product listing process.

MoCRA

The Modernization of Cosmetics Regulation Act of 2022 — the federal law that expanded FDA cosmetic authority and introduced mandatory facility registration and product listing.

Responsible Person (RP)

The manufacturer, packer, or distributor whose name appears on the cosmetic product label. The RP is legally accountable for listing, labeling, safety substantiation, and adverse-event reporting.

FDA Form 5067

The electronic FDA form used to submit a cosmetic product listing under MoCRA. Filed through the FDA Cosmetics Direct portal.

FDA Form 5066

The electronic FDA form used to register a cosmetic manufacturing or processing facility under MoCRA. Required before a Form 5067 product listing can be submitted.

Cosmetics Direct

FDA's official electronic submission portal for MoCRA cosmetic facility registrations and product listings.

CPLN

Cosmetic Product Listing Number — the unique identifier FDA assigns to an accepted product listing. Used to reference, amend, or confirm the listing.

INCI

International Nomenclature of Cosmetic Ingredients — the standardized naming system used to declare ingredients on a cosmetic label and on FDA Form 5067.

U.S. Agent

A U.S.-based representative designated by a foreign responsible person to receive FDA communications. Required under 21 CFR 207.69 for any foreign cosmetic filer.

Adverse Event

A health-related incident associated with a cosmetic product. Serious adverse events must be reported to the FDA within 15 business days under MoCRA section 605.

Safety Substantiation

Adequate scientific evidence supporting the safety of a cosmetic product under MoCRA section 608. The responsible person must hold and produce this evidence on FDA request.

Misbranding

A product whose labeling is false or misleading, or which fails a required disclosure under the FD&C Act. Failure to list under MoCRA can render a cosmetic misbranded under § 605.

Small Business Exemption

A narrow MoCRA exemption from registration and listing for very small cosmetic businesses with average annual gross U.S. cosmetic sales below the threshold defined in MoCRA § 612, excluding certain higher-risk product categories.

Common MoCRA Product Listing Failures

These are the failure modes we see most often when brands try to file MoCRA product listings without expert review.

Listing Filed Without a Valid Facility Registration

Product listings reference a facility registration number. Without a valid Form 5066 in place, the Form 5067 listing is rejected by Cosmetics Direct.

Incomplete or Non-INCI Ingredient List

Filing ingredients in common-name or marketing-name format instead of INCI causes the listing to be flagged for incomplete disclosure under 21 U.S.C. § 364c(b).

Wrong Responsible Person Designated

Listing the contract manufacturer as the RP instead of the brand owner whose name appears on the label — or vice versa — creates a mismatch between the FDA listing and the consumer-facing label.

Product Misclassified as Cosmetic vs. OTC Drug

Sunscreens, antiperspirants, and dandruff shampoos are OTC drugs, not cosmetics. Filing them on Form 5067 instead of FDA drug registration leads to enforcement action and import refusal.

Missed 60-Day Amendment Window

Material changes — new ingredient, label revision, new RP — must be filed within 60 days. Missing this window puts the listing out of compliance and exposes the brand to misbranding action.

Foreign Filer Without a Valid U.S. Agent

Foreign responsible persons must designate a U.S. Agent at a verifiable physical address. Listing a P.O. box or an agent who has not consented results in an invalid filing under 21 CFR 207.69.

Missing Fragrance / Flavor Disclosure

Fragrance and flavor allergens or trade-secret blends still require disclosure on FDA Form 5067 even if labeled simply as "fragrance" on the consumer label. Omission triggers FDA follow-up requests.

Failure to Renew Underlying Facility Registration

If the facility registration lapses, every product listing tied to it is suspended. The brand's products become unlisted and subject to import refusal until the registration is reinstated.

Complete MoCRA & Cosmetic Compliance Solutions

We offer a full range of FDA cosmetic compliance services under MoCRA — from facility registration and product listing to labeling review, U.S. Agent services, and state-level reporting.

Frequently Asked Questions — MoCRA Cosmetic Product Listing

+What is MoCRA Cosmetic Product Listing?

MoCRA Product Listing is the FDA-required process of electronically submitting detailed information about each cosmetic product you market in the United States. Listings are submitted using FDA Form 5067 and must include the product name, category, ingredients, labeling, and responsible person details.

+Who is required to submit MoCRA product listings?

Any company that markets cosmetic products in the United States — including domestic manufacturers, foreign manufacturers, brand owners, and responsible persons — must submit MoCRA product listings for each product sold in the U.S. market.

+What form is used for MoCRA product listing?

MoCRA cosmetic product listings are submitted electronically using FDA Form 5067. This form captures all required product information including name, category, ingredient list, labeling, and the responsible person associated with the product.

+What information is required for a MoCRA product listing?

A MoCRA product listing requires: product name(s), product category, responsible person information, facility registration reference, complete ingredient information (in INCI format), and labeling details as required by the FDA. All information must be accurate and current.

+Does product listing mean FDA approval?

No. MoCRA product listing does not constitute FDA approval, clearance, or endorsement of any cosmetic product. It is simply a mandatory regulatory reporting requirement that allows the FDA to maintain an accurate database of cosmetic products marketed in the United States.

+Do foreign cosmetic companies need to submit product listings?

Yes. MoCRA applies to all cosmetic products marketed in the United States, regardless of where they are manufactured. Foreign cosmetic companies selling products in the U.S. must submit MoCRA product listings for each product, just like domestic companies.

+When must a product listing be submitted?

Cosmetic product listings must be submitted to the FDA when a product is first marketed in the United States. Listings must also be updated whenever there are changes to product formulation, labeling, or responsible person information, and as required by FDA guidance.

+How often do product listings need to be updated?

Product listings must be updated whenever there are material changes to the product — including changes to the ingredient list, product name, labeling, or responsible person. The FDA also requires periodic review and confirmation of listing accuracy. We monitor your listings and manage all required updates on your behalf.

+Is MoCRA product listing separate from facility registration?

Yes — facility registration (Form FDA 5066) and product listing (Form FDA 5067) are two separate but related MoCRA requirements. Facilities that manufacture or process cosmetics must register, and the responsible person must submit product listings for all products marketed in the U.S. Both are required for full MoCRA compliance.

+What happens if I don't submit a MoCRA product listing?

Failure to submit required MoCRA product listings may result in FDA regulatory enforcement action, including warning letters, product detentions, or other compliance consequences. Timely and accurate product listing is a legal requirement for any company marketing cosmetics in the United States.

+What is a "responsible person" under MoCRA?

Under MoCRA, the responsible person is the manufacturer, packer, or distributor whose name appears on the cosmetic product label. The responsible person is legally responsible for ensuring the product is safe, properly labeled, and that all MoCRA obligations — including product listing — are fulfilled.

+Can I list multiple products at once?

Yes. Multiple cosmetic products can be submitted in a single MoCRA product listing filing. FDA Registration Assistance can prepare and submit listings for your entire product portfolio — ensuring every product in your line is accurately listed and compliant with FDA requirements.

+How long does it take to submit a MoCRA product listing?

With FDA Registration Assistance, most MoCRA product listings are prepared and submitted within 24–48 business hours once all required product information has been provided. The timeline may vary depending on the number of products and complexity of the ingredient information.

+Do I need a facility registration before listing products?

Yes. MoCRA product listings reference your facility registration number, so your cosmetic facility must first be registered with the FDA (Form FDA 5066) before product listings can be submitted. FDA Registration Assistance can handle both your facility registration and product listings together.

+What is the cost of MoCRA product listing assistance?

FDA Registration Assistance charges $199 USD per product for MoCRA product listing preparation and submission. This fee includes review of ingredient and labeling information, preparation of FDA Form 5067, electronic submission to the FDA, and confirmation of successful listing.

+Can FDA Registration Assistance handle product listings for me?

Yes. FDA Registration Assistance specializes in MoCRA cosmetic product listing preparation and submission. We manage the entire process on your behalf — from gathering product information and reviewing ingredients to submitting your listings and managing ongoing updates — so you can focus on your business.

+What exactly does the $199 MoCRA product listing fee include?

The $199 USD per-product fee covers full preparation and electronic submission of FDA Form 5067, INCI ingredient list review against MoCRA requirements, label compliance check against 21 CFR 701, responsible person designation review, FDA submission confirmation, delivery of your official Cosmetic Product Listing Number (CPLN), and one round of post-submission amendments within the first 30 days. There is no FDA government fee for filing — $0 to the FDA. For a typical single-product brand that also needs facility registration, the combined cost is $199 (per product listing) plus a separate facility registration fee — contact us for combined-bundle pricing covering Form 5066 + Form 5067.

+Can a friend, family member, or unrelated party act as the responsible person?

Technically yes — but it is strongly discouraged. Under MoCRA section 604, the responsible person must be the manufacturer, packer, or distributor whose name appears on the cosmetic product label, and is legally accountable for adverse-event reports, safety substantiation, label compliance, and FDA communications. Naming a friend or unrelated party who isn't actually involved in the business shifts that legal liability onto them, can invalidate label compliance under 21 CFR 701, and creates an inconsistency between the FDA listing record and the consumer-facing label. The RP should always be the real legal entity behind the brand.

+What happens if the responsible person doesn't respond to FDA inquiries?

The FDA escalates. Failure to respond to FDA communications can trigger Form 483 observations, warning letters, product seizure, import refusal under FDA import alerts, and — under MoCRA section 607 — suspension of the underlying facility registration, which automatically invalidates every product listing tied to it. The responsible person must also report any serious adverse event within 15 business days under MoCRA section 605; failing to do so is itself a separate violation. If you use FDA Registration Assistance as your U.S. Agent, we receive and forward all FDA communications immediately so nothing is missed.

+How do I change the responsible person on an existing MoCRA product listing?

File an amended FDA Form 5067 through the Cosmetics Direct portal identifying the new responsible person, their contact information, and the effective date of the change. Under MoCRA's material-change rules, the amendment must be filed within 60 days of the change to keep the listing compliant. FDA Registration Assistance handles the full amendment process — we file the updated Form 5067, notify the FDA of the RP transfer, update the linked facility registration where required, and deliver written confirmation to both the outgoing and incoming responsible persons.

+Are professional samples, free gifts, and hotel amenity cosmetics required to be listed under MoCRA?

Yes — they must be listed. MoCRA section 607 applies to any cosmetic product introduced into U.S. interstate commerce, regardless of whether it is sold, given as a sample, distributed as a promotional gift, or supplied to hotels, spas, and salons. Only products distributed strictly to licensed professionals for use on consumers — and not for retail resale — fall under a narrow professional-use exception, and even those must meet labeling and safety substantiation rules.

+Do I need to list products sold only on Amazon, Shopify, Etsy, Walmart, or TikTok Shop?

Yes — every cosmetic sold to U.S. consumers must be listed, regardless of sales channel. MoCRA applies to all cosmetic products marketed in the United States, and major platforms — including Amazon, Shopify, Walmart Marketplace, Etsy, and TikTok Shop — now require sellers to provide FDA MoCRA registration and product listing confirmation before activating cosmetic listings. Without an active FDA listing on file, your product can be removed from the platform without notice.

+Is MoCRA product listing required for soap, deodorant, or sunscreen?

It depends on the product's regulatory classification. True soap (made primarily from alkali salts of fatty acids and marketed only for cleansing) is exempt from MoCRA. Antiperspirant deodorants and sunscreens are regulated as OTC drugs under 21 CFR 310 and 21 CFR 352, not as cosmetics, so they require FDA drug registration — not MoCRA listing. Cosmetic-only deodorants (no antiperspirant claim) and after-sun moisturizers without SPF claims do require MoCRA product listing.

+How can I verify that my MoCRA product listing was accepted by the FDA?

You receive a Cosmetic Product Listing Number (CPLN) and a confirmation email from FDA's Cosmetics Direct portal once the submission is accepted. FDA Registration Assistance provides every client with their CPLN, a downloadable submission receipt, and a complete PDF copy of the filed Form 5067 for internal records and audit, distributor onboarding, or platform compliance review.

+Do contract manufacturers and private-label brands both need to list the same product?

No — only one listing per product is required, and it is filed by the responsible person whose name appears on the label. If you are a private-label or own-brand company selling under your own brand name, you are the responsible person and must file the product listing. The contract manufacturer separately registers their facility (Form FDA 5066) but does not file the product listing unless their own name appears on the consumer label.

+What address should I use if I'm a foreign company without a U.S. office?

Use your actual foreign business address for the responsible person record, but you must also designate a U.S. Agent at a verifiable U.S. physical address — not a P.O. box — under 21 CFR 207.69. The U.S. Agent receives all FDA correspondence on your behalf and is the FDA's primary point of contact in the United States. FDA Registration Assistance provides U.S. Agent services bundled with MoCRA product listing for foreign brands.

+Do I need a separate listing for each shade, size, or scent variant?

Not always. Under FDA's MoCRA guidance, variants that share the same formulation (for example, different sizes of an identical formula) can be grouped within a single product listing. However, color cosmetics with different shades — and therefore different colorant ingredients — typically require either separate listings or a single listing that declares every shade and every colorant. We review your full variant matrix during intake and file the minimum compliant number of listings for your product line.

+What if my ingredient list contains a trade-secret fragrance or flavor blend?

MoCRA section 607(b)(2) lets you label trade-secret fragrance or flavor blends simply as "fragrance" or "flavor" on the consumer-facing label. However, the responsible person must still submit the complete ingredient breakdown on FDA Form 5067 if requested by the FDA for safety review. FDA Registration Assistance files the consumer-compliant ingredient list on Form 5067 and maintains the full confidential breakdown on file, ready for FDA inspection.

+Are CBD, hemp, or cannabis-infused cosmetics covered by MoCRA?

Yes — if the product is marketed strictly as a cosmetic (no therapeutic claims), it falls under MoCRA and must be listed. However, any claim that the product treats, cures, or prevents a condition reclassifies it as an unapproved drug under the FD&C Act and removes it from cosmetic jurisdiction. CBD cosmetics also remain subject to FDA's ongoing position that hemp-derived CBD has not been determined to be GRAS or safe for cosmetic use, so listing alone does not equal FDA approval of the ingredient.

+Does a small business exemption apply to my brand?

Possibly — but the exemption is narrow. Under MoCRA section 612, a small business with average annual gross U.S. cosmetic sales below the statutory threshold (currently $1,000,000, adjusted for inflation) is exempt from both registration and product listing. However, the exemption does not apply to products that come into regular contact with the mucous membrane of the eye, injectable cosmetics, products intended for internal use, or products that alter appearance for more than 24 hours — those categories must always be listed regardless of company size.

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