Private Label Cosmetics Manufacturer for US Brands

MoCRA, labelling and your responsibilities

The Modernization of Cosmetics Regulation Act (MoCRA) introduced new FDA requirements for cosmetics sold in the United States, including facility registration, product listing, safety substantiation and adverse event reporting. Most product-level obligations sit with the responsible person, the manufacturer, packer or distributor whose name appears on the label, which for private label products is usually your brand or US importer. Rules and exemptions change, so please confirm your obligations with a US regulatory adviser.

We support you with the information these steps typically require: full formula and ingredient list, facility details, GMP certification, batch records and product specifications.

US label points to plan early

• Ingredient declarations follow FDA naming, which occasionally differs from EU INCI (for example “Water” rather than “Aqua”).
• Net contents are usually shown in both US customary and metric units.
• The label should name your company as responsible person and show the country of origin.
• Sunscreens are regulated as over-the-counter drugs in the US, not as cosmetics. We produce SPF products verified by SPF test, but US sunscreen launches carry additional requirements that should be reviewed before development.