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September 16, 2026October 12, 2026
CDSCO, Compliance Guides, Cosmetics Compliance, Import Compliance

CDSCO Import Registration for Lip & Cheek Tint in India: Standards, Documents and the Complete Process

Multi-use lip-and-cheek tints, liquid stains and gel tints colour both lips and cheeks, and each must be registered with CDSCO under the Cosmetics Rules, 2020 before import. Registration is product-level and tied to the specific formulation, its shades and the factory.

Because they are used on the lips, they are treated with the same strictness as a lip colour — the stain dyes and pigments must be India-permitted and the heavy-metal limits apply.

Is CDSCO Registration Mandatory for Lip & Cheek Tint?

Yes. Lip-and-cheek tints are Fourth Schedule colour / lip preparations and need CDSCO registration before import. The certificate covers the declared shades.

The application is filed by the overseas manufacturer or, in practice, its Authorised Indian Agent.

Applicable Standard for Lip & Cheek Tint

No single product-specific Indian Standard applies to a multi-use tint, so it is assessed against the country-of-origin standard plus the Cosmetics Rules, 2020 (a predominantly-lip tint aligns with IS 9875 in substance), with the CoA drawn against the manufacturer’s finished-product specification.

Every stain dye and pigment is declared by Colour Index (CI) number and mapped to IS 4707 (Part 1) and the Tenth Schedule, and heavy metals on the colourants are checked strictly (arsenic ≤ 2 ppm, lead ≤ 20 ppm, other heavy metals ≤ 100 ppm total) because a lip-and-cheek tint is worn on the lips and partly ingested. Each shade is a chargeable variant.

The Indian colour list is the only list that counts: a pigment permitted in the EU or US but not listed in IS 4707 (Part 1) and the Tenth Schedule will be refused. Map every CI number to the Indian list before you file.

A Lip Product First — Colour and Heavy Metals

A lip-and-cheek tint raises no drug question; it is judged as a lip colour, which is the stricter of its two uses. The recurring failures are a stain dye not on IS 4707 (Part 1) and heavy-metal exceedances on the colourants, because the tint is worn on the lips and ingested in small amounts. Shade reconciliation across the three documents is the other check.

Documents Required for Lip & Cheek Tint CDSCO Registration

Every Form COS-1 application needs the core document set — covering letter; First Schedule authorisation; Second Schedule Part-I; ingredient list with percentages; inner and outer labels; specification and method of testing; finished-product Certificate of Analysis; country-of-origin manufacturing licence or marketing authorisation; original Free Sale Certificate; non-animal-testing declaration; heavy-metal and hexachlorophene declaration; GMP / ISO 22716 certificate; correlation chart; Bharatkosh receipt; and the signed Form COS-1. On top of this base, Lip & Cheek Tint needs:

Colourant declaration listing every stain dye and pigment by CI number, mapped to IS 4707 (Part 1) and the Tenth Schedule.
Heavy-metals report on the colourants (As ≤ 2 ppm, Pb ≤ 20 ppm, other heavy metals ≤ 100 ppm total).
Certificate of Analysis against the country-of-origin specification.
Shade-wise composition sheet — each shade is a separate variant at USD 50.
Declaration that no lead or arsenic compounds have been used for colouring.
Microbiological report.

Label Requirements Specific to Lip & Cheek Tint

Shade name and number on the unit pack.
Registration Certificate number preceded by “RC” or “Reg. Cert. No.”.
Directions for use on lips and cheeks.
Net content by fluid measure or weight.

Step-by-Step: CDSCO Import Registration Process

Classify the product. Confirm it meets the definition of a cosmetic under Section 3(aaa) and map it to the lip / colour preparations category under the Fourth Schedule — this drives the fee and the certificate scope.
Appoint the Authorised Indian Agent. Execute the First Schedule authorisation, signed jointly by manufacturer and agent, then notarised and apostilled (Hague states) or embassy-attested.
Assemble the technical dossier. Ingredient list with INCI names and percentages, the finished-product CoA against the applicable standard, inner and outer labels, GMP / ISO 22716 evidence and the Free Sale Certificate.
Align the label to Chapter VI. Indian labelling is a top rejection reason; India-specific content may be stickered onto the unit pack at a bonded warehouse before clearance.
Pay the fee on Bharatkosh. Compute category + site + variant fees, pay online under head 0210041040000-00-1 and retain the acknowledgement receipt.
File Form COS-1 on SUGAM. Upload the full checklist, including the correlation chart that ties each product serial number in COS-1 to the Free Sale Certificate and the authorisation.
Respond to CDSCO queries. Reply within the stipulated period — each query effectively restarts the clock, so a clean first filing is the biggest lever on timeline.
Receive Form COS-2. Print the Registration Certificate number on every unit pack, with the holder’s name and address, before the goods are cleared for sale.

Fees and Timeline

Government fees are paid online via Bharatkosh under head 0210041040000-00-1: USD 1,000 for the lip / colour preparations category, USD 500 per manufacturing site and USD 50 per variant (shade, fragrance or formulation). A duplicate certificate is USD 200, permission for a novel ingredient is USD 500, and inspection of an overseas manufacturing site, if ordered, is USD 5,000.

Typical approval time is four to six months from acceptance of a complete application, and each CDSCO query effectively restarts the clock. The Registration Certificate is valid for five years from the date of issue and must be re-registered before it lapses.

Common Mistakes That Trigger a CDSCO Query

A stain dye / pigment with a CI number not on IS 4707 (Part 1).
Heavy-metals exceedance on the colourants for a lip product.
Shade lists that do not reconcile across the three documents.
Shades under-declared for the USD 50 variant fee.

Related Approvals to Plan Alongside CDSCO

DGFT Importer-Exporter Code — mandatory for any importer of record before the first consignment.
LMPC registration (Legal Metrology) — lip & cheek tint is a pre-packaged commodity requiring MRP, net quantity, importer details, country of origin and consumer-care details on the pack.
Wholesale licence (Form 20B / 21B) — where the Indian agent also distributes drugs alongside cosmetics.
Drug import licence (Form 10) — where a therapeutic claim or a pharmacologically active ingredient makes the product a drug rather than a cosmetic.

Frequently Asked Questions

Is CDSCO registration mandatory for imported lip and cheek tint?

Yes. Multi-use tints are Fourth Schedule colour / lip preparations and cannot be imported until registered under Rule 12(1) of the Cosmetics Rules, 2020, with the certificate issued in Form COS-2.

Which standard applies to a lip and cheek tint?

No single product-specific standard; it is assessed against the country-of-origin specification (a lip-led tint aligns with IS 9875 in substance), with colours on IS 4707 (Part 1).

Why are heavy metals scrutinised?

Because a lip-and-cheek tint is worn on the lips and partly ingested, so the colourant heavy-metal limits (As ≤ 2 ppm, Pb ≤ 20 ppm, others ≤ 100 ppm) are read strictly.

How are shades charged?

Each shade is a separate variant at USD 50 and must appear in the authorisation, the Free Sale Certificate and Form COS-1.

How long does registration take and how long is it valid?

Around four to six months for a complete application; the certificate is valid for five years and must be re-registered before expiry.

Do we need an Authorised Indian Agent?

In practice yes — the agent files on the First Schedule format and carries statutory liability for the product in India.

Why Choose PCN India Global

Claims triage — we confirm upfront whether your lip & cheek tint is cleanly cosmetic or at risk of drug reclassification.
Category mapping — the correct Fourth Schedule category and test scope confirmed for your formulation.
Dossier assembly — the full core document set prepared and cross-checked against the CDSCO checklist.
Label compliance — a Chapter VI review to correct any non-compliant or therapeutic wording before you print packaging.
End-to-end SUGAM filing — application, query response and the Form COS-2 grant managed for you.
Adjacent approvals — LMPC, DGFT/IEC and, where relevant, PESO/AYUSH coordinated alongside your CDSCO registration.

PCN India Global manages the complete CDSCO import registration process for lip & cheek tint — from claims triage and category mapping to dossier assembly, SUGAM filing and the Form COS-2 grant. WhatsApp or call +91 80109 05029, or email admin@pcnindiaglobal.com, to get your import registration underway.

Related Compliance Guides

Legal Metrology (LMPC) Registration
DGFT License Services (Importer-Exporter Code)
CDSCO Registration for Lipstick & Lip Colour
CDSCO Registration for Lip Liner & Lip Pencil
CDSCO Registration for Makeup Primer & Base
CDSCO Registration for Nail Polish Remover

Need expert help? See our CDSCO registration services.