💄 Module 09 of 17 — Registration Tracks

Cosmetics
& MoCRA

The cosmetics landscape changed permanently on December 29, 2022, when MoCRA was signed into law — the first major overhaul of U.S. cosmetics regulation since 1938. For the first time ever, facility registration, product listing, safety substantiation, and adverse event reporting became mandatory. Thousands of international beauty brands are still non-compliant. This module covers MoCRA inside out: what changed, what's required, how to register, the cosmetic-vs-drug boundary, INCI ingredient declarations, prohibited ingredients, color additives, labeling requirements, and the enormous consulting opportunity this law created.

📖 ~4,100 words · 17 min read

📅 Updated March 2026

⚖️ Covers 21 CFR Parts 700–740 + MoCRA

🎯 Level: Foundational → Expert

What Is a Cosmetic Under FDA Law

Under 21 U.S.C. § 321(i), a cosmetic is defined as an article intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance — and articles intended for use as a component of such articles. Critically, a cosmetic achieves its purpose by affecting appearance, not by affecting body structure or function.

This definition has not changed since 1938. What has changed — dramatically, under MoCRA — is what FDA requires of cosmetic companies. For 84 years, the cosmetics industry operated with virtually no pre-market review, no mandatory registration, and no required safety records. MoCRA ended that era entirely.

// The Historic Shift

Before MoCRA: No Registration Required. After MoCRA: All of This.

For 84 years (1938–2022), you could manufacture and sell cosmetics in the United States with essentially no interaction with FDA. No registration. No product listing. No safety records required by law. No mandatory adverse event reporting. No FDA recall authority. MoCRA changed every single one of those things. Every international beauty brand exporting to the U.S. is now legally required to engage with FDA in ways that simply did not exist three years ago.

What MoCRA Changed — The Complete Picture

Before MoCRA (Pre-December 2022)

After MoCRA (Now — Required)

Facility Registration

Completely voluntary. Almost no companies registered.

✅ MANDATORY. Every facility manufacturing or processing cosmetics for U.S. distribution must register with FDA. Deadline: December 29, 2023. Renewal every 2 years.

Product Listing

Voluntary. No legal requirement to list products with FDA.

✅ MANDATORY. Every cosmetic product must be individually listed with FDA including complete INCI ingredient list. Deadline: July 1, 2024. New products: within 120 days of market introduction.

Safety Substantiation

Industry practice and voluntary. No legal requirement to maintain records.

✅ LEGALLY REQUIRED. Manufacturers must maintain adequate evidence that each product is safe under conditions of use. Records must be available for FDA inspection. No specific test mandated but documentation required.

Adverse Event Reporting

Voluntary. No legal obligation to report adverse events to FDA.

✅ MANDATORY. Serious adverse events must be reported to FDA within 15 business days. Non-serious AEs: annual reporting. Records maintained for 6 years.

FDA Recall Authority

FDA could only request voluntary recalls. Companies could refuse.

✅ FDA CAN NOW MANDATE RECALLS. First time in history FDA has mandatory recall authority for cosmetics. Companies refusing a voluntary recall can now be ordered to recall.

GMP Requirements

No federal GMP regulations for cosmetics.

✅ FDA IS DEVELOPING GMP REGULATIONS. Currently ISO 22716 is the de facto standard. FDA expected to finalize cosmetics GMP rules by 2025–2026. Follow ISO 22716 now.

FDA Inspection Authority

Limited. FDA rarely inspected cosmetic facilities.

✅ ENHANCED. FDA now has explicit authority to inspect cosmetic manufacturing facilities and access records. This mirrors device and drug inspection authority.

MoCRA Registration — Step by Step

MoCRA registration is done through FDA's Cosmetics Direct portal — a separate system from FURLS (food/device) and DRLS (drugs). The portal is at cosmeticsdirect.fda.gov. Registration is currently free of charge, though MoCRA authorizes FDA to impose fees in the future.

Create an FDA Industry Account

Go to access.fda.gov → Create Account → Industry. The same FDA Industry Account used for food or device registration can be used to access Cosmetics Direct. If the client already has an FDA account, use that — don't create duplicates.

Determine Who Must Register

The "responsible person" under MoCRA — defined as the manufacturer or distributor whose name appears on the label — bears the registration obligation. For foreign manufacturers who sell to U.S. distributors that relabel the product, the U.S. distributor may become the responsible person and bear the registration obligation.

📋 Who is the Responsible Person? This is one of the most commonly misunderstood aspects of MoCRA for international brands. If a Korean manufacturer sells unlabeled product to a U.S. brand that puts its own name on the label — the U.S. brand is the responsible person, and they must register. If the Korean manufacturer sells a finished, labeled product with their own name on it to a U.S. distributor — the Korean manufacturer is the responsible person and must register their facility.

Required facility registration information:

Facility name and physical address (no P.O. boxes)
Facility's parent company name (if applicable)
Contact information for the facility
U.S. Agent name, address, phone, and email (for foreign facilities — the agent must reside in the U.S. and be available 24/7)
Brand names of cosmetics manufactured or processed at the facility
Product categories (from FDA's defined cosmetic product categories)

List Each Product Separately

Product listing is a separate step from facility registration — and is required for every product, not just the facility. Required product listing information:

Required Product Listing Elements:
• Product name (as it appears on the label)
• Product category (from FDA's defined cosmetic categories)
• Applicable cosmetic ingredient names — using INCI names, in the correct order
• Facility registration number (linking the product to the registered facility)
• Responsible person contact information
• Whether the product is marketed in the U.S. (current marketing status)

Important: If a product formula changes significantly — particularly if the ingredient list changes — the listing must be updated within 180 days. Product listings must also be updated if a product is discontinued or if the responsible person changes.

Set Up Adverse Event Reporting System

Establish an internal system to receive, record, evaluate, and report adverse events before any product is distributed. Serious adverse events (hospitalization, disfigurement, disability, congenital anomaly, death, or life-threatening events) must be reported to FDA within 15 business days of receiving the report. Non-serious adverse events associated with the product must be reported annually.

Maintain Safety Substantiation Records

Compile and maintain records demonstrating that each product is safe for its intended use. These records must be available for FDA inspection within 3 business days of an FDA request. The records do not need to be submitted to FDA — just maintained and accessible.

📋 What counts as safety substantiation? FDA has not specified a required format or specific tests. Acceptable evidence includes: ingredient safety assessments, toxicological evaluations, stability testing, challenge testing (for preservative efficacy), clinical safety studies, published literature on ingredient safety, and dermatologist assessment letters. The key is that the evidence must be "adequate" to show the product is safe — a standard FDA will interpret during inspections.

Renew Registration Every Two Years

Cosmetic facility registration must be renewed every 2 years. Unlike food (even-numbered years only) and drugs (annual), cosmetic renewal cycles are tied to the individual registration date — 2 years from when you first registered, then every 2 years thereafter. Set client-specific renewal reminders.

⚠️

Small Business Exemption — But Not a Full Exemption: Businesses averaging less than $1 million in annual gross sales of cosmetics over the previous 3 years are exempt from the facility registration and product listing requirements of MoCRA. However, they are not exempt from safety substantiation requirements, adverse event reporting obligations, or labeling requirements. The $1M threshold is lower than it sounds — many small international brands exceed it quickly once they begin U.S. distribution.

The Cosmetic-Drug Boundary — The Most Valuable Boundary to Know

The line between a cosmetic and a drug is the most commercially consequential classification decision in the beauty industry. Cross it accidentally and your product becomes an unapproved new drug that cannot legally enter the U.S. market. Know every nuance of this boundary — it is central to virtually every cosmetics consulting engagement.

The Definitional Test

A cosmetic affects appearance only — it does not affect the structure or function of the body. The moment a product (or its marketing) claims to affect the body's structure or function, it crosses into drug territory under 21 U.S.C. § 321(g)(1)(C).

Product

Claim / Marketing Statement

Classification

Moisturizer

"Moisturizes and softens skin. Leaves skin feeling silky smooth."

Cosmetic

Moisturizer

"Stimulates collagen production. Rebuilds skin's structural matrix at the cellular level."

Drug

Anti-Aging Serum

"Visibly reduces the appearance of fine lines and wrinkles."

Cosmetic

Anti-Aging Serum

"Clinically proven to reverse the signs of aging. Repairs DNA damage from UV exposure."

Drug

Hair Growth Product

"Makes hair look fuller and thicker. Adds volume to fine hair."

Cosmetic

Hair Growth Product

"Clinically proven to regrow hair. Stimulates dormant hair follicles."

Drug — requires NDA like Rogaine

Shampoo

"Cleanses and conditions hair. Leaves hair shiny and manageable."

Cosmetic

Shampoo

"Controls and prevents dandruff. Clinically proven anti-dandruff action."

OTC Drug + Cosmetic

Lip Balm with SPF 15

"Moisturizes lips while providing SPF 15 sun protection."

OTC Drug + Cosmetic

Body Lotion

"Provides deep hydration. Soothes dry skin. With vitamin E."

Cosmetic

Body Lotion

"Treats eczema. Relieves psoriasis symptoms. Anti-inflammatory formula."

Drug — unapproved

Deodorant (no antiperspirant)

"Keeps you fresh and odor-free all day. Long-lasting fragrance."

Cosmetic

Antiperspirant/Deodorant

"48-hour sweat protection. Clinically proven to reduce perspiration by 35%."

OTC Drug (antiperspirant) + Cosmetic

🚫

The Social Media Trap for Beauty Brands: A cosmetic label can be perfectly legal while the company's Instagram, TikTok, or YouTube makes drug claims that convert the product to a drug. FDA monitors online content and treats it as labeling under 21 U.S.C. § 321(m). "Our serum repairs DNA damage" posted on Instagram — even in a caption, even in a comment response — is a drug claim that converts the product to an unapproved new drug. Always audit the complete digital presence, not just the physical label.

Dual-Regulated Products — Cosmetic + OTC Drug

Some products are simultaneously cosmetics and OTC drugs. This is one of the most practically important concepts for beauty brand consultants — it doubles the compliance requirements. When a product is dual-regulated, it must comply with both sets of requirements simultaneously.

Product	Cosmetic Function	Drug Function	Both Sets Apply
SPF Moisturizer	Moisturizes skin (cosmetic)	SPF sun protection (OTC drug — sunscreen monograph)	Drug Facts panel + cosmetic INCI ingredient list + MoCRA registration + OTC drug establishment registration
Dandruff Shampoo	Cleanses hair (cosmetic)	Controls dandruff (OTC drug — antidandruff monograph)	Drug Facts panel + cosmetic labeling + OTC drug GMP + cosmetic and drug establishment registration
Fluoride Toothpaste	Cleans teeth, freshens breath (cosmetic)	Prevents cavities — fluoride (OTC drug — anticaries monograph)	Drug Facts panel + all OTC requirements. Toothpaste is primarily a drug, regulated under drug framework.
Antiperspirant + Deodorant	Deodorant function — odor masking (cosmetic)	Antiperspirant — reduces sweating (OTC drug — antiperspirant monograph)	Drug Facts panel required. "Deodorant only" products without antiperspirant function: cosmetic only.
Medicated Acne Wash	Cleanses skin (cosmetic)	Treats acne — benzoyl peroxide or salicylic acid (OTC drug — acne monograph)	Drug Facts panel mandatory. Active ingredient (BPO or SA) concentration must comply with acne monograph limits.

INCI Ingredient Declarations — The Standard You Must Know

Under 21 CFR § 701.3, cosmetic ingredient declarations must use the names established by the International Nomenclature of Cosmetic Ingredients (INCI) system. INCI names are standardized, globally recognized ingredient names maintained by the Personal Care Products Council (PCPC). Using trade names, common names, or chemical abstracts names instead of INCI names on a cosmetic label is a labeling violation.

INCI Ordering Rules

All ingredients present at concentrations above 1%: Listed in descending order of predominance — the ingredient with the highest concentration is listed first
All ingredients at 1% or below: Can be listed in any order after the above-1% ingredients
Color additives: Can be listed in any order at the end of the ingredient list, regardless of concentration
Fragrance: Listed as a single entry — "Fragrance" or "Parfum" — without individual fragrance ingredient disclosure (subject to evolving fragrance allergen disclosure rules under MoCRA)
Flavor: Listed as "Flavor" without individual disclosure

Common Name / Marketing Name

Correct INCI Name

Notes

Water / Eau / Aqua

Aqua

Always listed first in most formulas; highest concentration

Vitamin C / Ascorbic Acid

Ascorbic Acid

"Vitamin C" is a marketing name — not acceptable on INCI list

Vitamin E / Tocopherol

Tocopherol

Different forms: Tocopheryl Acetate, Alpha-Tocopherol — each has its own INCI

Hyaluronic Acid / HA

Sodium Hyaluronate

Most common form in cosmetics is Sodium Hyaluronate (salt form), not the acid itself

Retinol / Vitamin A

Retinol

Retinol is actually an INCI name. Retinyl Palmitate, Retinyl Acetate are different INCI names

Glycerin / Glycerol

Glycerin

"Glycerol" is not the INCI name — must use Glycerin

Niacinamide / Vitamin B3

Niacinamide

Niacinamide is the correct INCI; "Vitamin B3" is not acceptable

Coconut Oil

Cocos Nucifera (Coconut) Oil

Plant oils typically use Latin botanical name — common name in parentheses acceptable

Aloe Vera / Aloe Gel

Aloe Barbadensis Leaf Juice

"Aloe Vera" alone is not an INCI name — full botanical name required

Petroleum Jelly / Vaseline

Petrolatum

"Vaseline" is a brand name — never use brand names in INCI declarations

✅

Where to look up INCI names: The authoritative INCI name database is the International Cosmetic Ingredient Dictionary and Handbook published by the Personal Care Products Council (PCPC) — available at cosmeticsinfo.org. For quick lookups: ewg.org/skindeep or the EU's CosIng database both reference INCI names. When in doubt, search the EU CosIng database — it is comprehensive and free.

Prohibited and Restricted Ingredients

The United States has far fewer prohibited cosmetic ingredients than the European Union — the EU prohibits or restricts over 1,300 ingredients while the U.S. only explicitly prohibits a small number. However, FDA does have a list of prohibited and restricted cosmetic ingredients, and violating these is one of the fastest ways to have a product detained or seized at the U.S. border.

Bithionol

An antiseptic banned from cosmetics due to photosensitivity reactions. Sometimes still found in international products marketed as antibacterial skincare.

21 CFR § 700.11

Mercury (except eye-area preservatives at ≤0.0065%)

Mercury compounds in skin-lightening products are a major international issue. Common in products from parts of Asia, Africa, and Latin America. Causes severe neurological and kidney damage.

21 CFR § 700.13 — enforced aggressively at U.S. border

Vinyl Chloride (aerosols)

Banned as a propellant in aerosol cosmetic products due to carcinogenicity. Must not be used in hairspray, deodorant sprays, or any cosmetic aerosol.

21 CFR § 700.14

Halogenated Salicylanilides

Antibacterial compounds (tribromsalan, tetrachlorosalicylanilide) banned from cosmetics due to severe skin sensitization and cross-reaction with other drugs.

21 CFR § 700.15

Zirconium (aerosols)

Zirconium-containing complexes banned from aerosol cosmetics due to lung granuloma formation risk. Allowed in non-aerosol stick deodorants at specific limits.

21 CFR § 700.16

Chlorofluorocarbons (CFCs)

CFC propellants banned in cosmetic aerosols. Also banned under EPA regulations. Still occasionally found in imported aerosol products from countries with less strict environmental regulation.

21 CFR § 700.23

Methylene Chloride

Solvent banned in cosmetics due to carcinogenicity. Was commonly used in hair spray formulations. Sometimes found in paint strippers that are improperly marketed as cosmetics.

21 CFR § 700.19

Prohibited Cattle Materials (BSE risk)

Certain cattle-derived materials (brain, spinal cord, eyes, skull, vertebral column from cattle 30 months or older) banned to prevent transmission of BSE (Mad Cow Disease) through cosmetic products.

21 CFR § 700.27

⚠️

Mercury in Skin-Lightening Products — The Most Common Import Violation: FDA has found mercury in skin-lightening, complexion-lightening, and anti-aging creams — particularly from manufacturers in China, Mexico, Dominican Republic, and several African countries. Products with mercury are seized at the border and have generated import alerts. Always test imported cosmetics for mercury before advising any skin-lightening client to export to the U.S. FDA's import alert covering mercury in cosmetics is actively maintained.

Color Additives — A Separate Approval System

Color additives in cosmetics are regulated separately from other cosmetic ingredients and require FDA approval before use. This is one of the areas where many international brands run into unexpected violations — a color that is perfectly legal in the EU, Japan, or their home country may be unapproved in the U.S.

Certified Color Additives (Batch Certification)

Synthetic dyes that must be batch-certified by FDA before use. Examples: FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 5. Each batch of the certified dye is tested by FDA — the manufacturer receives a certification number that must appear in the ingredient list. Cannot use these without a valid certification certificate. Most are approved for all cosmetic uses, but some have eye-area restrictions.

Exempt From Certification (Natural Colors)

Colors derived from natural sources — plants, minerals, or animals — that are exempt from batch certification. Examples: carmine (CI 75470), annatto, beta-carotene, ultramarine blue, iron oxides. Still require FDA approval and must be listed in the ingredient declaration. Some have use restrictions (e.g., only for external use, not for eye area).

Colors Approved Elsewhere but NOT in U.S.

Many colors approved in the EU, Japan, or Australia have never received FDA approval for use in cosmetics sold in the U.S. Examples: CI 26100 (D&C Red No. 17 — approved for non-eye-area cosmetics in EU but limited in U.S.), various colorants approved under EU's positive list but absent from FDA's approved list. Always check 21 CFR Part 73–82 before using any color in a U.S.-destined cosmetic.

Eye-Area Color Restrictions

Many colors approved for general cosmetic use are specifically prohibited for use in eye-area products. Coal-tar hair dyes, certain synthetic dyes, and colors that are not specifically approved for eye use cannot be in products applied near or around the eyes. Eye area products include: eyeshadow, mascara, eyeliner, eye cream, eye primer. This restriction is strictly enforced — unapproved colors in eye-area products = adulterated cosmetic.

How to verify color additive approval status: Step 1: Check 21 CFR Parts 73, 74, 81, and 82 at ecfr.gov Step 2: Part 73 = Colors exempt from certification (natural colors) Part 74 = Certified colors (synthetic dyes — FD&C, D&C) Part 81 = General color additive regulations Part 82 = Certified batch numbers (how to list on label) Labeling colors on a cosmetic ingredient declaration: Certified color: "FD&C Blue 1" or "CI 42090" — either name acceptable Natural color: "Iron Oxides (CI 77491, CI 77492, CI 77499)" — list CI numbers Carmine: "Carmine" or "CI 75470" or "Carmine (CI 75470)" — FDA requires "Carmine" to appear if using this colorant (new requirement) EU vs. U.S. color naming — the confusion trap: EU uses CI numbers (Color Index) — e.g., CI 15850 (D&C Red No. 7 in U.S.) U.S. uses FD&C/D&C names — these must appear on U.S. labels Both names can appear on U.S. labels — just ensure U.S. name is present

Cosmetic Labeling Requirements — Complete Guide

Cosmetic labeling is governed by 21 CFR Part 701. All required elements must appear in English (additional languages are permitted). The requirements are less prescriptive than food labeling but still have specific placement, format, and content rules.

Cosmetic Label Requirements Checklist

21 CFR Part 701 + MoCRA requirements

Element

Requirements

Status

Product Identity

Name of the cosmetic product. Must be on the principal display panel (PDP). If the product name doesn't make the nature of the product obvious, a description must be added (e.g., "Face Serum" below the product name). No misleading names that imply unapproved drug effects.

MANDATORY

Net Quantity

Net weight, volume, or count of contents. Must appear in the bottom 30% of the PDP. Dual declaration required: both U.S. units AND metric (e.g., "1 FL OZ (30 mL)"). Minimum type size based on PDP area. This is one of the most commonly wrong elements on international cosmetic labels.

MANDATORY

Distributor/Manufacturer Name & Address

Name and address of the manufacturer, packer, or distributor. Qualifying phrase required if not the manufacturer: "Manufactured for [name]," "Distributed by [name]," or "Imported by [name]." Must include city, state/country, and ZIP/postal code. For foreign manufacturers: country of manufacture must be stated.

MANDATORY

Ingredient Declaration (INCI)

All cosmetic ingredients in INCI names. Descending order for ingredients above 1% concentration. Below 1% in any order. Color additives in any order at end. Fragrance listed as "Fragrance" or "Parfum." Must appear on the information panel (back or side). Font size: minimum 1/16 inch height.

MANDATORY

Required Warnings

Specific warnings required for certain cosmetic types: aerosols (flammability, inhalation warnings), coal tar hair dyes (contact dermatitis, patch test instructions), products containing AHAs (sun sensitivity warning), self-tanners, products for professional use only.

IF APPLICABLE

Directions for Use

Required only if needed for safe use or if the product would be hazardous without specific directions. Must be adequate for safe consumer use. If the product has a specific application method that affects safety, directions are mandatory.

IF NEEDED FOR SAFETY

No "FDA Approved" Claim

Cosmetics are never "FDA Approved" — using this phrase is illegal misbranding. "Manufactured in an FDA-registered facility" is acceptable. "Made in compliance with FDA regulations" is acceptable. "FDA Approved" or "FDA Certified" for a cosmetic are always violations.

PROHIBITED

Fragrance Allergen Disclosure (Upcoming)

MoCRA requires FDA to develop regulations for fragrance allergen labeling. Rulemaking is ongoing (2024–2026). This will likely require specific fragrance allergens to be individually disclosed on labels — similar to EU fragrance allergen rules. Monitor FDA's rulemaking for implementation dates and requirements.

COMING SOON

Safety Substantiation — What "Adequate Evidence" Means

MoCRA requires responsible persons to maintain records demonstrating adequate evidence that the cosmetic is safe under conditions of use. FDA has not specified a required test or format — but they have made clear that "adequate evidence" means substantive, documented scientific evidence, not just general claims that ingredients are "natural" or "safe."

🧪

Ingredient Safety Assessments

A document-by-document review of safety data for each ingredient — literature searches, CIR (Cosmetic Ingredient Review) assessments, EU SCCS opinions. The backbone of most safety files. Every ingredient should have documented safety evidence.

🔬

Toxicological Risk Assessment

Formal safety assessment combining ingredient exposures with toxicological data to evaluate the risk of the finished product. Required for more complex formulas or products with potentially sensitizing ingredients. Performed by a qualified toxicologist.

⏱️

Stability Testing

Documents that the product remains safe and effective (and maintains its label claims) throughout its shelf life. Typically includes: accelerated aging studies, challenge testing (if preservatives used), and real-time stability data. Required for all finished cosmetics with shelf life claims.

🛡️

Preservative Efficacy Testing

Demonstrates that the product's preservation system is adequate to prevent microbial contamination during normal consumer use (repeated opening, dilution with water, storage). Tested per USP <51>, ISO 11930, or PCPC Challenge Test methodology.

👨‍⚕️

Dermatological / Clinical Testing

Human patch testing, repeat insult patch testing (RIPT), photosensitization studies, and clinician assessment letters. Most persuasive evidence of safety — but expensive. Required for products with potentially sensitizing ingredients or for products marketed for sensitive skin.

📚

Published Literature

Peer-reviewed scientific publications documenting the safety of individual ingredients or similar formulations. Used to supplement other evidence. CIR (Cosmetic Ingredient Review) panel safety assessments are FDA-recognized and publicly available at cir-safety.org.

ℹ️

CIR — Cosmetic Ingredient Review: The CIR is an industry-sponsored expert panel that independently evaluates the safety of cosmetic ingredients. CIR safety assessments are published in peer-reviewed journals and are available free at cir-safety.org. FDA has recognized CIR assessments as appropriate safety substantiation evidence. When a client asks what safety documentation they need, CIR assessments for each ingredient are a solid starting point — especially for ingredients that have been in wide use for years.

The MoCRA Opportunity — Why This Is a Gold Rush for Consultants

MoCRA created the largest single compliance opportunity in the cosmetics industry in 84 years. Here is why — and how to position Regovant to capture it:

🌍

Thousands of Unregistered International Brands

Every beauty brand in South Korea, Japan, China, France, Brazil, India, and the Middle East that exports to the U.S. was required to register by December 2023 and list products by July 2024. A significant proportion have not done so — either because they don't know about MoCRA, or because they don't know how to comply.

Opportunity: $1,500–$3,500 per facility + $100–200 per product

🏷️

Label Review for INCI Compliance

Virtually every international cosmetic brand has labeling issues when entering the U.S. market — wrong ingredient names (not INCI), missing net quantity in U.S. units, missing distributor address format, incorrect color additive names. A comprehensive label review for a beauty client with multiple SKUs is a substantial engagement.

Opportunity: $800–$2,500 per product; $3,000–$8,000 for a brand's full line

🔒

Safety File Development

Many small and mid-sized beauty brands have never compiled a formal safety file. MoCRA now requires one for every product. Building safety files — ingredient assessments, stability data, preservative efficacy, toxicological review — is a high-value, specialized service that commands premium fees.

Opportunity: $2,000–$10,000 per product depending on complexity

🧑‍💼

US Agent Service for Foreign Cosmetic Brands

Foreign cosmetic facility registrations require a U.S. Agent — available 24/7, U.S.-based. Every foreign cosmetic brand registering under MoCRA needs one. Regovant's U.S. Agent service is directly applicable and can be packaged as an annual retainer alongside registration and compliance support.

Opportunity: $800–$2,000/year per facility (recurring revenue)

// Real-World Scenario — The K-Beauty Brand

A Korean Skincare Company — 14 Products, No MoCRA Compliance

A Korean skincare brand ("Glow Seoul") has been selling through a U.S. distributor since 2020. They have 14 SKUs — serums, moisturizers, toners, sheet masks, and a sunscreen. Revenue from U.S. distribution: $800,000/year. They've heard about MoCRA but haven't done anything. You meet them at a trade show in March 2026. Here is what they need:

Facility Registration: Register their Seoul manufacturing facility via Cosmetics Direct. Appoint Regovant as U.S. Agent. Estimated: $1,800 for registration + $1,500/year US Agent fee.
Product Listing — 14 products: List each product individually with FDA including full INCI ingredient lists. Review all 14 INCI declarations for accuracy. Estimated: $200/product × 14 = $2,800.
Label Review — 14 labels: Review every label for: INCI accuracy, net quantity (Korean labels show mL only — need fluid oz + mL), manufacturer address format, color additive naming, product identity clarity, and any drug claim language. Estimated: $1,200/label × 14 = $16,800.
Sunscreen — Special Issue: Their SPF 50+ sunscreen uses UV filters (Tinosorb M, Tinosorb S) that are approved in Korea and the EU but NOT in the U.S. under the sunscreen monograph. This product cannot legally enter the U.S. market in its current formulation. They must reformulate using only FDA-approved sunscreen active ingredients (avobenzone, zinc oxide, titanium dioxide, etc.) or pursue a Time and Extent Application (TEA) for new sunscreen active approval — a multi-year process. Estimated advisory: $3,000 + ongoing TEA support if desired.
Safety Files: Compile safety substantiation files for all 14 products using available CIR assessments, EU SCCS opinions, and stability data already generated for Korean regulatory compliance. Estimated: $1,500/product × 14 = $21,000.
Adverse Event System Setup: Establish an AE reporting SOP and a mechanism to receive and report consumer complaints. Estimated: $2,500 one-time setup.

Total engagement value: approximately $48,000 — plus $1,500/year recurring US Agent fee and future product additions as they expand their line.

✅ This is a representative example of what a single MoCRA compliance engagement looks like for an established international beauty brand. The work is well-defined, repeatable, and high-value. Glow Seoul's alternative — non-compliance — is a U.S. distributor that eventually discovers the non-compliance and cancels the contract, or FDA detecting the unregistered facility and issuing a warning letter that makes the news in Korea.

✦ Module 09 — Key Takeaways

MoCRA (December 2022) created mandatory cosmetics regulation for the first time in 84 years. Every facility manufacturing cosmetics for U.S. distribution must register via Cosmetics Direct (deadline: December 2023). Every product must be listed (deadline: July 2024). Safety substantiation records and adverse event reporting are now legally required.
The cosmetic-drug boundary is determined by intended use. A cosmetic affects appearance only. The moment any marketing claim suggests the product affects body structure or function — on any platform including social media, websites, and Amazon listings — the product becomes a drug. "Stimulates collagen production," "repairs DNA damage," and "treats eczema" are drug claims that convert cosmetics to unapproved new drugs.
Dual-regulated products (cosmetic + OTC drug) must comply with both sets of requirements simultaneously — Drug Facts panel, OTC drug GMP, OTC drug establishment registration, AND cosmetic facility registration under MoCRA. Common dual-regulated products: sunscreens, dandruff shampoos, fluoride toothpaste, antiperspirants, medicated acne washes.
INCI names are mandatory for cosmetic ingredient declarations in the U.S. Descending order by concentration above 1%; any order below 1%; colors in any order at end; fragrance as single "Fragrance" entry. Common errors: using marketing names ("Vitamin C" instead of "Ascorbic Acid"), using brand names ("Vaseline" instead of "Petrolatum"), and incorrect botanical INCI names.
Color additives require separate FDA approval — not all colors permitted elsewhere are approved in the U.S. Certified colors (FD&C, D&C) require batch certification numbers on labels. Natural colors (iron oxides, carmine, beta-carotene) are exempt from batch certification but still require FDA approval for their specific use. Eye-area restrictions apply to many colors approved for general use.
Mercury in skin-lightening products is the most commonly detected prohibited ingredient at U.S. ports of entry — particularly in products from Asia, Africa, and Latin America. Always test imported skin-lightening cosmetics before advising export to the U.S. Mercury import alerts are actively enforced.
MoCRA created a massive consulting opportunity: facility registration, product listing, INCI label review, safety file development, US Agent service, and adverse event system setup are all discrete, billable services that thousands of international beauty brands need right now. A single well-established Korean, Japanese, or European brand can represent a $30,000–$60,000+ initial engagement.

Is your cosmetic brand MoCRA compliant?

Regovant handles facility registration, product listing, INCI label review, safety file development, and US Agent services for international beauty brands entering the U.S. market.

Get MoCRA Compliant Today →

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Dietary Supplements — DSHEA, Claims, GMP & NDI