U.S. Cosmetics Market • MoCRA • OTC Drugs • Imports
The U.S. Cosmetics Market for European, Asian and Latin American Companies
A comprehensive market-entry and FDA compliance guide for foreign and domestic manufacturers, exporters, importers, distributors, private-label brands, online sellers and retailers marketing conventional cosmetics or cosmetic-drug combination products in the United States.
Introduction
A Major Consumer Market With Product-Specific Regulatory Duties
The United States offers substantial opportunities for cosmetics companies from Europe, Asia and Latin America. Foreign brands reach American consumers through direct-to-consumer websites, Amazon and other marketplaces, specialty beauty retailers, pharmacies, salons, department stores, subscription programs, private-label partnerships and importer-distributor networks. Consumers purchase facial skincare, body moisturizers, color cosmetics, eye and lip makeup, hair-care products, deodorants, sun-care products and specialized beauty treatments from international companies every day.
Market access, however, requires more than appointing a distributor or translating an existing package into English. A product offered in the United States must comply with applicable U.S. laws even when it was lawfully marketed under European Union, United Kingdom, Korean, Japanese, Chinese, Brazilian, Mexican, Colombian or another national regulatory system. U.S. classification, ingredient controls, color-additive requirements, labeling, safety substantiation, facility registration, product listing, adverse-event reporting, import procedures, state requirements and retailer policies must be evaluated separately.
One of the most important distinctions is the difference between a conventional cosmetic and a drug. The expression “OTC cosmetic” is commonly used in commerce, but it is not a separate legal category. Sunscreen, antidandruff shampoo, antiperspirant, acne treatment or a moisturizer with sun-protection claims may be regulated as over-the-counter drugs and often as both cosmetics and drugs. Classification depends on intended use, including the formula, active ingredients, claims, directions, labeling, website statements, images, advertising and consumer expectations.
A formula or claim accepted in another country is not automatically lawful in the United States. Complete a U.S.-specific regulatory review before printing labels, producing large quantities, appointing distributors or shipping inventory.
Chapter 1
International Opportunities in the U.S. Beauty Market
European companies
European brands often enter with pharmacy-inspired skincare, luxury fragrance, botanical formulations, clean-beauty concepts, salon products or dermatology-oriented positioning. Existing EU safety files can be useful, but they do not replace U.S. labeling, MoCRA, color-additive, claims or OTC drug review.
Asian companies
Korean, Japanese, Chinese, Indian and Southeast Asian brands compete through serums, masks, essences, lightweight sunscreens, cushion makeup, lip tints and innovative application formats. Whitening claims, UV claims, eye-area pigments and therapeutic statements require special attention.
Latin American companies
Companies from Brazil, Mexico, Colombia, Argentina, Peru, Chile and other countries may emphasize tropical botanicals, textured-hair expertise, body care, fragrance and sun care. Ingredient identity, English labeling, substantiation and import documentation should be standardized before launch.
Foreign companies should choose whether to sell through a U.S. subsidiary, importer, exclusive distributor, multiple distributors, marketplace seller account or private-label customer. That structure affects contracts, inventory ownership, customs responsibilities, complaint communication, label identity and access to records.
Chapter 2
Conventional Cosmetics, OTC Drugs and Dual-Purpose Products
Conventional cosmetics
Products intended primarily to cleanse, beautify, promote attractiveness or alter appearance may be conventional cosmetics. Ordinary moisturizers, non-medicated cleansers, foundation, blush, mascara, lipstick, shampoo, conditioner, hair color and deodorant can fall in this category when their claims remain cosmetic.
OTC drugs
A product is a drug when intended to diagnose, cure, mitigate, treat or prevent disease, or affect the structure or function of the body. Sunscreen, acne treatment, antidandruff treatment, antiperspirant and certain skin protectants are common examples.
Both cosmetic and drug
A moisturizing lotion with SPF can beautify and prevent sunburn. Antidandruff shampoo cleans hair and treats dandruff. Antiperspirant deodorant controls odor and reduces perspiration. Dual-purpose products must comply with both applicable systems.
Statements such as “treats acne,” “repairs eczema,” “stimulates collagen,” “regenerates cells,” “heals skin,” “prevents infection,” “grows eyelashes” or “reverses hair loss” may create drug intended use. FDA does not recognize “cosmeceutical” as a separate legal category.
Chapter 3
Facial and Body Skincare
Face moisturizers
Creams, lotions and gels intended to hydrate, soften or smooth skin are generally conventional cosmetics. Claims to treat eczema, heal cracked skin or medically restore barrier function may require drug analysis.
Facial cleansers
Non-soap washes, cold creams, cleansing liquids, micellar waters and makeup removers are usually cosmetics when intended only to cleanse. Antibacterial, acne-treatment or infection-prevention claims may create drug intended use.
Sunscreens and tanning
Sunscreens are OTC drugs in the United States. A lotion, spray, foundation or lip product with SPF or sunburn-prevention claims may be both cosmetic and drug. Self-tanning products may be cosmetics, but inhalation, eye-area use and color-additive issues still require review.
Face masks and serums
Masks, ampoules, essences and serums may be cosmetics when marketed for hydration, softness, brightness of appearance or temporary cosmetic improvement. Blemish-treatment, melasma, rosacea or inflammation claims can create drug issues.
Body lotions
Hand and body creams intended to moisturize are generally cosmetics. Products claiming to protect minor cuts, burns or chapped skin may fall within an OTC skin-protectant framework.
Specialized treatments
Products for acne, hyperpigmentation, eyelash growth, hair growth, psoriasis, fungal conditions, pain or scarring deserve heightened review. Location in a skincare aisle does not determine FDA classification.
Chapter 4
Face and Color Makeup
Foundations
Liquid, cream, powder, cushion, stick and mineral foundations are cosmetics when intended to even skin tone. SPF claims can make them both cosmetics and sunscreen drugs.
Concealers
Products covering dark circles, redness and blemishes are usually cosmetics. Acne-treatment, healing or anti-inflammatory claims may change their status.
Face powders
Setting, finishing, pressed and loose powders are cosmetics. Talc-containing products require strong supplier qualification and impurity controls.
Blushes
Powder, cream, stick, gel and liquid blushes are cosmetics. Each color additive must be permitted for the intended area of use.
Highlighters and contours
These products shape facial appearance, create depth or add shine. Metallic pigments, glitter and eye-area crossover use require careful review.
Makeup with treatment claims
“Skincare makeup” remains subject to intended-use analysis. Hydrating and smoothing claims may remain cosmetic, while acne-treatment and sun-protection claims can create drug obligations.
Chapter 5
Eye and Lip Makeup
Mascara
Mascara darkens, defines and lengthens the appearance of eyelashes. Claims to stimulate growth or treat eyelash loss may create drug concerns.
Eyeliners
Pencils, gels and liquids are cosmetics. Microbial control, suitable color additives and safe use near the eye are essential.
Eyeshadows
Powder and cream eyeshadows are cosmetics. A pigment allowed for general cosmetic use is not automatically permitted around the eyes.
Eyebrow products
Pencils, powders and clear or tinted gels are cosmetics. Regrowth claims may create drug intended use.
Lipsticks
Colored lip creams and sticks are cosmetics. Color additives must be permitted for lip use, and contaminant controls are important because incidental ingestion is foreseeable.
Lip glosses and balms
Shiny or moisturizing lip products are generally cosmetics. SPF, cold-sore, analgesic or skin-protectant claims may make them OTC drugs as well.
Chapter 6
Hair Care and Personal Cleanliness
Shampoos
Ordinary cleansing shampoos are cosmetics. Antidandruff shampoos are both cosmetics and OTC drugs because they cleanse hair and treat dandruff. Hair-loss, antifungal or psoriasis claims may create additional drug issues.
Hair conditioners
Rinse-out conditioners, leave-ins, masks, oils and detanglers are cosmetics when intended to smooth, soften or improve appearance. Claims to alter follicles or permanently repair biology should be reviewed.
Hair coloring
Temporary, semi-permanent and permanent dyes are cosmetics but have specialized ingredient, warning, patch-test and contamination considerations.
Deodorants
Underarm sticks, roll-ons and sprays intended only to control odor may be cosmetics. Products intended to reduce perspiration are antiperspirant drugs and may also be cosmetics.
Chapter 7
MoCRA Compliance for Conventional Cosmetics
The Modernization of Cosmetics Regulation Act of 2022 expanded FDA authority and established significant industry duties. Manufacturers and processors of cosmetic products for distribution in the United States generally must register applicable facilities unless an exemption applies. Facility registrations must be renewed every two years, and certain changes must be updated within the required period.
The responsible person is the manufacturer, packer or distributor whose name appears on the cosmetic label. The responsible person must submit a cosmetic product listing for each marketed product, including required product and ingredient information, and provide required annual updates. The responsible person also has duties involving safety substantiation, adverse-event reporting, records, labeling and recall readiness.
Facility obligations
- Determine which manufacturing or processing sites must register.
- Register and renew applicable facilities biennially.
- Update facility information after relevant changes.
- Identify a U.S. agent for a registered foreign cosmetic facility.
- Maintain controlled manufacturing and inspection-ready records.
Responsible person obligations
- List marketed cosmetic products with FDA.
- Provide required annual listing updates.
- Maintain adequate safety substantiation.
- Receive and evaluate adverse-event information.
- Report serious adverse events within the required period.
- Ensure required contact information appears on the label.
Certain small businesses may qualify for exemptions from selected MoCRA requirements, but the exemptions are limited. Small size does not eliminate the obligation to market safe, non-adulterated and non-misbranded cosmetics.
A foreign cosmetic facility subject to registration must identify a U.S. agent. The responsible person may be located inside or outside the United States. The U.S. agent is not automatically the responsible person, importer, distributor or marketplace seller.
Chapter 8
OTC Drug Requirements for Cosmetic-Drug Products
Sunscreens, antidandruff shampoos, antiperspirants, acne products and certain skin protectants may be marketed under an applicable OTC monograph or an approved drug application. A monograph functions as a category rulebook addressing lawful active ingredients, strengths, dosage forms, indications, directions, warnings, testing and other conditions.
A foreign or domestic manufacturer cannot rely only on a familiar active ingredient. The finished product must satisfy the complete legal pathway. Drug establishment registration, drug listing, labeler-code and National Drug Code coordination, current good manufacturing practice, specifications, stability, testing, complaint handling, adverse-event processes and Drug Facts labeling may apply.
Registration and listing do not constitute FDA approval. An NDC is not evidence that FDA reviewed or approved the formulation, label, claims or manufacturing operation.
Chapter 9
U.S. Labeling and Claims
Core cosmetic label elements
- Statement of identity.
- Accurate net quantity of contents.
- Ingredient declaration in the required order and nomenclature.
- Name and place of business of the manufacturer, packer or distributor.
- Required domestic contact information for adverse-event reporting.
- Applicable warnings and directions.
- English-language information with adequate prominence and legibility.
Claim-control priorities
- Keep cosmetic claims focused on cleansing, beautifying or appearance.
- Review names, taglines, websites and marketplace listings.
- Support objective performance and duration claims.
- Avoid implying FDA approval or endorsement.
- Review translations for therapeutic meaning.
- Confirm testimonials do not create drug claims.
Labels developed for another market often require more than translation. European ingredient conventions, Asian bilingual layouts, Latin American distributor statements, metric-only net contents and non-U.S. contact information may need modification. The physical label, website, Amazon listing, insert and advertising should present consistent identity and intended use.
Chapter 10
Safety Substantiation and Quality Controls
Companies marketing cosmetics have a legal responsibility to ensure safety. Under MoCRA, the responsible person must maintain records supporting adequate substantiation of safety. A generic Certificate of Analysis alone is rarely a complete safety file.
A risk-based program may include formula review, toxicological assessment, raw-material specifications, supplier qualification, microbial limits, preservative-effectiveness testing, stability, packaging compatibility, heavy-metal controls, restricted-substance review, color-additive verification and finished-product release criteria. Eye products, lip products, water-based cosmetics, children’s products, talc-containing products, aerosols and novel botanicals may need additional controls.
Foreign companies should ensure that ingredient names, supplier documents and test reports can be linked to the exact formula, batch, manufacturing site and retail product. A U.S. distributor cannot respond effectively when records remain fragmented among multiple foreign suppliers.
Chapter 11
Importing Cosmetics Into the United States
Confirm classification and legality
Determine whether the product is a conventional cosmetic, OTC drug, dual-purpose product or another regulated category. Review ingredients, color additives, claims and labels.
Complete registrations and listings
Address cosmetic facility registration, cosmetic product listing, foreign-facility U.S. agent, drug establishment registration and drug listing where applicable.
Finalize U.S.-compliant labels
Confirm English information, net contents, ingredients, warnings, adverse-event contact, Drug Facts where applicable, lot coding and country-of-origin marking.
Assign customs and commercial roles
Identify the Importer of Record, customs broker, owner or purchaser, consignee, distributor and warehouse. These roles are separate from the responsible person and U.S. agent.
Prepare accurate entry documentation
Commercial invoices, packing lists, product descriptions, values, tariff classifications, manufacturer data and FDA information should be consistent.
Plan for inspection or detention
Imported cosmetics must meet the same applicable FDA requirements as domestic products. FDA may examine, sample, detain or refuse products that appear unlawful.
Chapter 12
Responsibilities Across the Supply Chain
Manufacturer
Controls formulation, ingredients, processing, specifications, quality records, batch release and many registration inputs.
Exporter
Coordinates production, shipment documents, foreign records, U.S. contacts and communication with the importer.
Importer of Record
Handles customs-entry responsibilities involving classification, value, origin and documentation.
Responsible person
Manages core MoCRA product obligations, including listing, safety substantiation, adverse events and label contact information.
Distributor
Manages sales channels, inventory, complaints, returns and retailer communications. Contracts should define records access and recall duties.
U.S. Agent
Serves as the U.S. communications contact for a registered foreign cosmetic facility or foreign drug establishment, as applicable.
Chapter 13
Complaints, Adverse Events and Recall Readiness
Consumer complaints are not only customer-service matters. Reports of allergic reactions, eye injuries, infections, burns, hospitalization or other serious outcomes may trigger investigation and reporting duties. The responsible person must report serious adverse events associated with cosmetic products in the United States to FDA within the required period and submit qualifying additional information received later.
A complaint procedure should identify the product, lot, consumer, event, medical outcome, distribution history, returned sample and investigation steps. Foreign manufacturers and U.S. distributors should agree on how quickly information will be transmitted across time zones and languages.
Recall readiness should include lot traceability, customer and distributor lists, warehouse inventory, e-commerce orders, public communications, regulatory notifications, disposition instructions and effectiveness checks.
Chapter 14
Services Provided by U.S. FDA Consultants
Product classification
Evaluate formula, ingredients, intended use, claims, packaging and marketing to determine the applicable category.
MoCRA registration
Support FEI coordination, facility registration, foreign-facility U.S. agent service, renewal, updates and exemption analysis.
Cosmetic product listing
Prepare and maintain listings, categories, facility references, ingredient data and annual updates.
OTC drug registration
Assist with establishment registration, drug listing, U.S. agent service, labeler codes and NDC coordination.
Formula review
Review restricted ingredients, color additives, drug actives, supplier data and U.S.-specific formulation concerns.
Label and claims review
Review identity, net contents, ingredients, warnings, business information, contact data, Drug Facts and online claims.
Safety substantiation
Help define the safety file, testing plan, specifications, stability support and finished-product release documentation.
Quality and SOPs
Develop procedures for complaints, adverse events, recalls, suppliers, deviations, corrective actions and batch release.
Import support
Coordinate with exporters, importers and brokers and support responses to examination, detention or document requests.
Retailer compliance
Organize labels, test reports, authorization letters, invoices, registrations and response packages for Amazon and other retailers.
Inspection readiness
Conduct gap assessments, mock inspections, management training, records review and corrective-action tracking.
Ongoing maintenance
Track renewals, updates, facility changes, new products, revised formulas, complaints and regulatory developments.
A consultant can provide regulatory assistance but cannot transfer the legal responsibilities of the manufacturer, responsible person, drug labeler, importer or distributor. No consultant should promise guaranteed FDA approval, customs release or retailer acceptance.
Conclusion
Build Sustainable U.S. Market Access
European, Asian and Latin American cosmetics companies can bring innovation, cultural expertise, premium formulations, distinctive ingredients and trusted regional brands to American consumers. The strongest market-entry strategy combines those commercial strengths with a disciplined U.S. regulatory program.
Facial moisturizers, cleansers, masks, serums, body lotions, foundations, concealers, powders, blushes, highlighters, mascara, eyeliners, eyeshadows, eyebrow products, lipsticks, lip glosses, shampoos, conditioners, hair colors and deodorants may be conventional cosmetics when claims remain cosmetic. Sunscreens, antiperspirants, antidandruff products, acne treatments and other therapeutic products may also be OTC drugs. Correct classification is the foundation for every later decision.
Domestic and foreign manufacturers, exporters, importers, responsible persons, distributors and retailers should define their roles, maintain access to records and coordinate complaints and recalls. Compliance should be completed before large production runs and international shipments, not after a retailer rejection, customs hold, adverse event or FDA inquiry.
Prepare Your Cosmetics Brand for the United States
ITB HOLDINGS LLC assists foreign and domestic cosmetics companies with product classification, MoCRA facility registration and product listing, foreign-facility U.S. agent service, OTC drug registration and listing, formula and ingredient review, label and claims review, safety documentation, import support, SOP development, retailer compliance and ongoing maintenance.
Before printing U.S. labels, appointing an importer, signing a distribution agreement or shipping inventory, request a product-specific compliance assessment. Early review can identify regulatory gaps and create a more reliable path to the U.S. cosmetics market.
