MoCRA for Baby Care Brands: Facility Registration & Product Listing (Who Does What)

Under the Modernization of Cosmetics Regulation Act (MoCRA), Mom & Baby care brands importing or manufacturing for the U.S. market now face federally enforceable requirements for facility registration and product listing. This guide breaks down the “who does what” so that brand owners, sourcing managers, and manufacturing partners can align responsibilities, prevent regulatory gaps, and keep launch timelines intact.

Key Responsibilities Under MoCRA

Facility Registration

• Manufacturer or Processor: Must register each physical facility producing baby care products intended for the U.S., submitting FDA-required data annually or when changes occur.
• Brand Owner (if manufacturing in-house): Assumes the manufacturer’s registration obligations.
• Evidence to Keep: FDA acknowledgment letter or proof of submission, facility identification number, and confirmation of updates.

Product Listing

• Responsible Person: Usually the brand owner; can be delegated to regulatory consultants.
• Includes: Each marketed baby care SKU with detailed ingredient list in accordance with INCI nomenclature, as well as product category and intended use.
• Evidence to Keep: FDA listing confirmation, ingredient breakdown, and associated facility linkages.

Who Does What – Quick Table

Coordination Tips for Baby Care Brands

• Assign a single compliance lead to track both facility and product listing deadlines.
• Use synchronized data sheets so manufacturer and brand owner work from the same specification set.
• Review ingredient naming conventions early to avoid listing rejections.
• Schedule annual compliance reviews ahead of the busiest production months.

Common Pitfalls & How to Avoid Them

• Missed updates after formula change: Keep a change log and notify regulatory lead within 5 business days.
• Incorrect facility linkage: Cross-check the FDA record against active SKUs before filing.
• Lack of INCI conformity: Reference official naming standards in your production documentation.

FAQ

Who is considered the “Responsible Person” under MoCRA?

Typically the brand owner or entity marketing the product in the U.S.; they are accountable for product listing accuracy and timeliness.

Can my overseas manufacturer handle registration for me?

Yes, for facility registration they can submit directly, but the brand must ensure the data is accurate and linked to marketed products.

What if I change an ingredient in my baby lotion?

You must update the product listing with the FDA to reflect the new formula, even if the change is minor.

Are private label products subject to MoCRA?

Yes, both the facility producing them and the brand marketing them must meet registration and listing requirements.

How often is registration renewed?

Annually, or within 60 days of a material change to the facility information.

Request a Quote today with your target market, product SKUs, formulations, and timeline to ensure your baby care launch meets MoCRA requirements without delays.

Hi, I'm Alex Zong, hope you like this blog post.

With more than 20 years of experience in OEM/ODM/Private Label Cosmetics, I'd love to share valuable knowledge related to cosmetics & skincare products from a top-tier Chinese supplier's perspective.