What labeling elements are required for cosmetic products?

According to FDA and FPLA guidelines, cosmetic labels must include: • Statement of identity (product name) • Net quantity of contents (weight, measure, or numerical count) • Ingredient list in descending order of predominance • Name and place of business (manufacturer, packer, or distributor) • Warnings and precautions (if applicable)

How does the FDA differentiate between cosmetics and drugs?

• Cosmetics: Products intended to cleanse, beautify, or alter appearance (e.g., moisturizers, perfumes, makeup). • Drugs: Products that treat or prevent disease or affect the structure or function of the body (e.g., anti-dandruff shampoos, acne treatments). Improper claims can result in drug classification, requiring additional FDA approvals.

What ingredients are prohibited in U.S. cosmetics?

The FDA prohibits ingredients such as: • Bithionol • Chloroform • Methylene chloride • Vinyl chloride • Halogenated salicylanilides (in cosmetics) • Unsafe color additives without proper certification We ensure ingredient compliance to avoid enforcement actions.

What are the labeling requirements for imported cosmetics?

• Country of origin labeling is mandatory. • Accurate ingredient declarations using INCI names. • Compliance with color additive certifications (if applicable). • We assist with import documentation and customs clearance.

Are “organic” and “natural” claims regulated?

• "Organic" claims are regulated by the USDA, not the FDA. • "Natural" claims are not strictly defined by the FDA, but must not be misleading. We ensure marketing claims are accurate and legally compliant.

What happens if my cosmetic product fails FDA compliance?

• FDA can detain or refuse entry of imported products. • Enforcement actions, such as warning letters and recalls, may be issued. • We help with corrective actions, reformulations, and re-submissions.

Cosmetic Label & Ingredient Review (FDA/MoCRA)

Overview

Service overview

We review your cosmetic labels, ingredients and marketing claims against FDA and FPLA rules and flag anything that risks misbranding or drug classification.

Product documentation being reviewed for compliance

Why this service matters

The FDA does not pre-approve cosmetics, but it regulates labelling and ingredient safety.
Prohibited or restricted ingredients and drug-like claims are common problems.
Non-compliance can lead to detentions, entry refusals, warning letters and recalls.

Full Cosmetic Labelling Compliance Review

We review your cosmetic product labels in full, including layout, claims and ingredient listings.

Font size, placement, and language checks for FDA compliance
Assessment of marketing claims to avoid drug classification
Country of origin labelling and proper ingredient listings

Cargo containers moving through an international port — Medical Devices & Cosmetics
Cosmetic Labelling Compliance & Ingredient Review

Cosmetic Ingredient Review & Safety Assessments

The FDA prohibits certain cosmetic ingredients and monitors for unsafe substances, and we assess your ingredients and formulation against US rules.

Ingredient list reviews against FDA banned and restricted substance lists
Assessments for fragrance components, colour additives, and preservatives
Cross-checking against international standards (EU, Canada, and ASEAN)

Marketing Claims Compliance & Review

Improper marketing claims can reclassify a cosmetic as a drug, so we check your claims against FDA definitions for cosmetics.

Verification of organic, vegan, and cruelty-free claims compliance
Label disclaimers and warnings to meet US requirements
Assessment of claims that could trigger drug classification

Colour Additive Certification & Compliance

Colour additives in cosmetics require FDA certification for domestic and imported products, and we help you meet colour additive rules.

Verification of permitted colour additives
Compliance with usage limitations and application-specific guidelines
Ingredient documentation support for import clearance

International Cosmetic Labelling Compliance (UK & EU Markets)

Cosmetics for international markets must meet regional requirements, including UK (CTPA) and EU (Regulation EC No 1223/2009) standards.

Ingredient safety assessments per EU Cosmetic Ingredient Database (CosIng)
Translation and localisation of labelling for international distribution
Support for product notifications under EU Cosmetic Product Notification Portal

US Cosmetic Product Ingredient Statement (CPIS) Assistance

CPIS submissions are voluntary but can support import clearance and FDA oversight, and we help prepare and submit them.

Compilation of ingredient lists for CPIS submissions
Accurate reporting of product categories and intended uses
Submission through FDA's Voluntary Cosmetic Registration Program (VCRP)

Ongoing compliance support

Time-Saving
Labels, claims and ingredients are reviewed together in one process.
Regulatory Assurance
Checks aligned with FDA and FPLA labelling rules for cosmetics.
Peace of Mind
Reduce the risk of detentions, refusals and misbranding issues at the border.

What you'll need

Send the label and full formula so claims and ingredients can be checked together.

Label artworkEvery panel, for font, placement and language checks.
Full ingredient listIncluding fragrance, colour additives and preservatives.
Marketing claimsOrganic, vegan or cruelty-free wording, and any efficacy claims.
Target marketsUS, UK or EU distribution plans.

Free tool

Cosmetic Labelling Compliance & Ingredient Review