MoCRA Registration and Product Listing Support for Beauty Brands

The Modernization of Cosmetics Regulation Act changed what a cosmetic brand has to be able to produce on request. Vaulabs is an FDA-registered, MoCRA compliant manufacturer in Clearwater, Florida, and we build the documentation into the project rather than assembling it after a retailer asks.

What MoCRA actually requires

• Facility registration. The facility that manufactures or processes your product must be registered with the FDA and must renew that registration. Ours is.
• Product listing. Each cosmetic product needs an FDA listing that includes its ingredients. The listing is tied to the responsible person for the product, which in most cases is the brand, not the manufacturer.
• Safety substantiation. The responsible person must hold adequate evidence that the product is safe. That is testing and documentation, not an opinion.
• Adverse event recordkeeping. Serious adverse events must be reported, and records kept for a defined period.
• Labeling. Contact information for adverse event reports must appear on the label, and fragrance allergen disclosure requirements apply.

What we handle and what stays with you

We want to be precise here, because this is where brands get surprised. Facility registration is ours. Good manufacturing practice compliance, batch records and certificates of analysis are ours. Safety substantiation is a shared job: we run the testing and hand you the reports, and you hold the file as the responsible person. The product listing itself is filed by the responsible person, and we supply the ingredient data and formulation details it requires.

We do not file your listing for you and then let you assume it is handled. We tell you which submissions are yours before development starts.

The documentation we produce

• Certificate of analysis for your specific batch, not a template with a new date on it.
• Product specifications and finished goods specifications.
• Accelerated stability reports. Three months of data supports a one year shelf life, six months supports two years.
• Preservative efficacy and challenge testing.
• Allergen statements and ingredient disclosure in INCI format.
• Free Sale Certificates for export.
• Dermatological safety testing when the claim or the category calls for it.

Where brands get caught

The two most common problems we see are a product already in market with no safety file behind it, and a label that was designed before anyone checked the disclosure requirements. Both are fixable, but they are cheaper to fix before a run than after ten thousand units are printed.

If you are bringing an existing product to us from another manufacturer, we can review what documentation exists and tell you plainly what is missing.

Standards the facility holds

FDA-registered, NSF-certified under NSF/ANSI 455-2 (certificate C0681369-HSCDS-5, valid through May 27, 2027), MoCRA compliant, with USDA Certified organic capability for formulas that require it. In-house R&D, quality control, regulatory and production, in Clearwater, Florida.

Ask us about your product

Tell us what you are selling, where you are selling it, and what documentation you already hold. If your file is complete, we will say so. Vaulabs LLC, Clearwater, Florida.