Private label cosmetics for US brands, made in India

US brands and importers can source private label cosmetics from India, but imported cosmetics must meet the same US laws as products made in the United States. The US Food and Drug Administration (FDA) regulates cosmetics under the Federal Food, Drug, and Cosmetic Act, and the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) added duties for facility registration, product listing, safety substantiation and adverse event reporting. We manufacture in our own facility in Ambala, Haryana, India, and supply the technical information. The US responsible person handles the product-level duties. This page explains who does what, what goes on the label and which documents to expect from us.

Who is legally responsible when you sell cosmetics in the USA?

MoCRA places most product-level duties on the responsible person: the manufacturer, packer or distributor whose name appears on the product label. For a private label product made in India and sold under your brand, that is normally your US company, named on the label with wording such as "Distributed by". It is not us.

According to FDA, the responsible person must:

• List each marketed cosmetic product with FDA, including its ingredients, and keep the listing up to date.
• Ensure and keep records supporting the product's safety. FDA notes that the law does not prescribe specific tests.
• Report serious adverse events to FDA, and provide contact details on the label through which consumers can report adverse events.

Separately, facilities that manufacture or process cosmetics for distribution in the United States must register with FDA, and FDA guidance asks foreign facilities to name a US agent. FDA provides the Cosmetics Direct electronic submission tool for registration and listing. Certain small businesses are exempt from registration and listing, with exceptions for some product types, so check with your adviser.

Does FDA approve cosmetics before they go on sale?

No. FDA states that cosmetic products and ingredients do not need FDA premarket approval, with the exception of colour additives, which must be approved for their intended use. FDA also states that registration and listing are not an approval programme, and that a registration or listing number does not mean FDA has approved a product.

Our facility is a US FDA registered facility. That is a fact about where products are made. It is not an FDA approval of any product, and it does not replace the product listing and other duties of your responsible person.

What has to happen before products go on sale?

1. Confirm the product is a cosmetic. FDA classes a product by its intended use. Products for cleansing, beautifying or changing appearance are cosmetics. Claims about acting on the body or on disease can make a product a drug, which brings different rules.
2. Check ingredients and colour additives. Colour additives must be approved by FDA for the intended use. Your adviser checks each formula, especially makeup.
3. Substantiate safety. The responsible person keeps records supporting the product's safety, drawing on the formula, specifications and stability information we supply.
4. Register and list. The facility is registered and the responsible person lists each product, as FDA requires.
5. Finalise the label to US requirements before print.

What goes on a US cosmetic label?

FDA's summary of labelling requirements says all label statements required by regulation must be in English. A US label typically carries:

• Identity of the product on the principal display panel, the part most likely to be seen at retail.
• Net quantity of contents on the principal display panel, by weight, measure or count.
• Name and place of business of the firm on the label, with "Manufactured for" or "Distributed by" where that firm is not the manufacturer.
• Ingredient declaration for retail products, generally in descending order of predominance.
• Warnings and directions where needed for safe use, including statements required for certain product types.
• Country of origin, using the English name, for example "Made in India".
• Adverse event contact. A domestic address, domestic phone number or electronic contact through which the responsible person receives adverse event reports.

Which documents will your US importer ask us for?

Our testing and documents service prepares the product paperwork.

Which ranges suit the US market?

• Skincare, keeping claims to appearance, cleansing and feel so products stay within cosmetic rules.
• Body care, including body wash, lotions and butters for retail and gift lines.
• Hair care, such as shampoo, conditioner, serums and masks with cosmetic claims.
• Makeup, where every colour additive must be checked against FDA's rules before shades are fixed.

How does an order to the USA work with us?

1. Brief. Tell us the products, US channels and your responsible person.
2. Shortlist and sample. Samples are available on request; ready formulas start from 500 units per product.
3. Review. Your adviser checks ingredients, colour additives and claims.
4. Documents and label. We supply technical documents; you approve English artwork with your US details.
5. US steps. Your responsible person completes product listing and safety substantiation.
6. Production and shipment through our fulfilment and export service.

Timelines depend on the formula, label approval and your filings. See how it works and our guide to exporting cosmetics from India.

Next step

Send your product list and US channels through the inquiry form for US orders. FDA continues to issue rules and guidance under MoCRA, so always confirm current requirements with your importer or a regulatory adviser before products go on sale.