MoCRA Label Compliance

Your cosmetic label can decide whether your product makes it to U.S. shelves. With Sobel’s MoCRA label compliance service, we review your labels, highlight gaps, and guide you through the necessary corrections—so your cosmetics are ready for the U.S. market without delays.

For who?

Under MoCRA, labels must follow strict FDA rules on ingredient disclosure, formatting, and accuracy. Let Sobel guide you through every detail to keep your labels compliant.

Why do you need this service?

MoCRA has made FDA-compliant labeling a legal requirement. Your cosmetic products cannot be sold in the U.S. without meeting these standards.

Even small errors or missing information on labels can trigger recalls, import holds, or enforcement actions that disrupt your market entry.

Having accurate, transparent labels builds consumer trust and positions your brand as reliable and professional.

How to achieve MoCRA label compliance

Sobel provides expert guidance to identify label gaps, refine revisions, and verify ingredient listings—ensuring your packaging aligns with MoCRA and FDA requirements.

We break the process into clear actions so your labels meet FDA rules without unnecessary complications.

Document Request

We request from your team all label files and supporting documents needed for review.

Label Verification

Review of current labeling against MoCRA and FDA cosmetic requirements.

Gap Assessment Report

A detailed report outlining missing or non-compliant elements, with recommendations.

Revision Guidance

Support in updating the label according to findings, including one guided revision.

MoCRA Alignment

Final confirmation that labels match current FDA documentation practices.

Related
Services

Beyond MoCRA label compliance, Sobel offers complementary services to help your cosmetics remain compliant in every step of the regulatory process:

Safety Substantiation

Compilation of safety data to support cosmetic product compliance with MoCRA requirements.

Cosmetic FDA Package

Registration, label review, and safety substantiation for full regulatory compliance.

Change in Cosmetic Registration

Support with FDA cosmetic registration changes, from documentation review to submission.

Bring your cosmetic labels into MoCRA compliance

Your product label is more than packaging—it’s a legal requirement under MoCRA.

With Sobel as your partner, you gain expert support to review, revise, and validate your cosmetic labeling—streamlining market entry and supporting ongoing compliance.

Still have questions? Checkout our FAQ

1. What is MoCRA label compliance?

MoCRA label compliance means ensuring that cosmetic product labels meet the new FDA rules introduced under the Modernization of Cosmetics Regulation Act, covering ingredient disclosure, formatting, and accuracy.

2. What information must be included on cosmetic labels?

Labels must clearly list ingredients using INCI names, display warnings when required, identify the responsible person, and follow FDA formatting standards. Sobel reviews each label and provides guidance on missing or incorrect details.

3. Do foreign cosmetic brands need to adapt labels for MoCRA compliance?

Yes. All cosmetics marketed in the U.S. — whether manufactured domestically or abroad — must comply with MoCRA label requirements before distribution.

4. What happens if a cosmetic label does not comply with MoCRA?

Non-compliant labels can lead to enforcement actions such as product holds, recalls, fines, or delays in U.S. market access.

5. What kind of support does Sobel provide for MoCRA label compliance?

Sobel conducts a full label verification, prepares a gap assessment report, and offers guidance for revisions — including one guided revision — so your products are compliant and ready for the U.S. market.