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Delivering Compliance and Innovation for Cosmetic Products

Cosmetics

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How We Support You

Cosmetic Regulatory Compliance & FDA Registration

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has introduced new requirements for cosmetic manufacturers, packers, and distributors. If you market cosmetics in the U.S., FDA facility registration and product listing are now mandatory. xFDA provides expert guidance to ensure full compliance, helping you navigate FDA regulations efficiently.

Our Cosmetic Services

FDA Cosmetic Facility Registration & Product Listing

Cosmetic Facility Registration

Most cosmetic manufacturing facilities, including contract manufacturers producing products for the U.S. market, must register with the FDA and update their registration annually. Facility registrations must be renewed every two years.

✔ Facilities outside the U.S. require a U.S. Agent—xFDA can serve as your representative.

Cosmetic Product Listing

If your brand name appears on a cosmetic product (manufacturer, packager, or distributor), you must submit a product listing to the FDA, which includes:
✔ A complete ingredient list, including fragrances, flavors, and color additives
✔ Manufacturer facility name and location
✔ Responsible party information
✔ JPG images of product labels (≤ 1MB)
✔ Annual updates for any formulation or label changes

How xFDA Can Help

  • ✔ Cosmetic Facility Registration – Assisting with initial registration, updates, and renewals
    ✔ Cosmetic Product Listing – Ensuring accurate data submission and compliance with FDA requirements
    ✔ U.S. Agent Services – Representing international facilities as required by the FDA
    ✔ Label Review & Compliance – Ensuring your product labeling aligns with FDA cosmetic regulations

Listing & Registration Exemptions

  • ✔ Injectables
    ✔ Products that come in contact with the eye
    ✔ Internal-use cosmetics
    ✔ Long-lasting cosmetics

    Are not eligible for exemptions and must comply with FDA regulations regardless of revenue.

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Why Choose xFDA for Cosmetics Compliance?

Navigating the evolving landscape of cosmetic regulations requires expertise and precision. xFDA’s team of former FDA regulators and industry experts provides strategic guidance to help cosmetic companies achieve and maintain compliance with confidence.

What Sets Our Experts Apart:

✔ Former FDA regulators with hands-on experience in cosmetic compliance
✔ Expertise in MoCRA regulations, facility registration, and product listing
✔ In-depth knowledge of FDA labeling, GMP requirements, and exemptions
✔ Trusted advisors for international and domestic cosmetic manufacturers
✔ Dedicated U.S. Agent services for foreign cosmetic facilities

With xFDA’s expertise, your cosmetic products will meet FDA compliance standards, ensuring regulatory success.

Don’t Wait To Start

Work with Our Experts

Navigating FDA cosmetic regulations can be complex, but xFDA is here to help. Whether you need registration assistance, compliance support, or expert advisory services, our team is ready to guide you.

Need help with FDA cosmetic compliance? Contact us today to discuss your regulatory needs with an xFDA consultant.