Lip balms, lip butters, lip masks and lip treatments are the care side of the lip shelf, 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 variants and the factory.
Unlike most lip and skincare products, a lip balm has a dedicated Indian Standard, and because it is worn on the lips and partly ingested, the safety of its colourants and the framing of any medicated claim are what decide the filing.
📌 Under Rule 12(1) of the Cosmetics Rules, 2020, no Lip Balm & Lip Care may be imported into India unless the product is registered by the Central Licensing Authority. The application is Form COS-1 on the CDSCO SUGAM portal, and the approval is issued as an Import Registration Certificate in Form COS-2 — it must be in place before the first consignment lands.
📋 Is CDSCO Registration Mandatory for Lip Balm & Lip Care?
Yes. Lip balm and lip care are Fourth Schedule lip-care preparations and require CDSCO registration before import. A tinted balm additionally carries the colourant rules, and a medicated or SPF balm brings extra evidence.
The application is filed by the overseas manufacturer or, in practice, its Authorised Indian Agent.
📘 The Indian Standard in Detail
Lip salve and lip balm are covered by IS 10284, and the Certificate of Analysis is drawn against it. A tinted lip balm additionally declares its colours by CI number against IS 4707 (Part 1) and the Tenth Schedule, and — because lip products are ingested in small amounts — heavy metals on any colourant are checked against the general limits (As ≤ 2 ppm, Pb ≤ 20 ppm, others ≤ 100 ppm total).
Where the balm claims an SPF, it needs an accredited SPF report and the printed SPF must not exceed the tested value; where it claims to treat chapped or cracked lips medically, or contains a medicated active, it moves toward the drug route.
🗂️ The Core Document Set — Required for Every Application
Whatever the product, Form COS-1 carries the same core dossier. Getting this base right is what decides whether the file clears in one pass or comes back as a query letter; the product-specific documents in the next section sit on top of it.
- Covering letter — states the purpose (fresh registration, endorsement of a product, site or pack size, or re-registration), references any earlier certificate and points to the correlation charts.
- Authorisation from the manufacturer (First Schedule) — names the manufacturer, every manufacturing premises, the Authorised Indian Agent and each product, variant and pack size; signed jointly on every page, then notarised and apostilled (Hague states) or embassy-attested.
- Part-I of the Second Schedule — company and product particulars, chemical information and the nine statutory undertakings, completed afresh for each COS-1.
- Ingredient list with percentages — INCI nomenclature, percentage of each ingredient, signed by a competent person; must exclude anything listed in Annex A of IS 4707 (Part 2).
- Inner and outer labels — legible originals for the product and every variant, compliant with Chapter VI.
- Specification and method of testing — the finished-product specification and test method, signed and stamped.
- Finished-product Certificate of Analysis — a batch CoA against the applicable Ninth Schedule Indian Standard, or against country-of-origin standards where no Indian Standard exists.
- Manufacturing licence / marketing authorisation — an authenticated copy from the country-of-origin regulator, or a manufacturer's undertaking where no such regime exists.
- Free Sale Certificate (FSC) — original, from the National Regulatory Authority of the country of origin; if issued by a chamber of commerce, apostilled or embassy-attested, and the product list signed and stamped.
- Non-animal-testing declaration — that the products have not been tested on animals after 12 November 2014.
- Heavy-metal and hexachlorophene declaration — a test report for Pb, As, Hg and other heavy metals plus microbiological results, or a manufacturer's undertaking of compliance.
- GMP / ISO 22716 certificate — evidence of cosmetic Good Manufacturing Practice at the overseas site.
- Correlation chart — maps each product serial number in COS-1 against the FSC and the Authorisation; missing or inconsistent charts are among the most common causes of query letters.
- Bharatkosh fee receipt — acknowledgement of the fee paid under head of account 0210041040000-00-1.
- Duly signed Form COS-1 — original, with every detail matching the Authorisation and Second Schedule Part-I exactly.
➕ Extra Documents for Lip Balm & Lip Care
On top of the core dossier above, a lip-balm application needs:
- Certificate of Analysis against IS 10284 (lip salve).
- Colourant declaration by CI number against IS 4707 (Part 1) and the Tenth Schedule for a tinted balm.
- Heavy-metals report on the colourants (As ≤ 2 ppm, Pb ≤ 20 ppm, other heavy metals ≤ 100 ppm total).
- SPF test report (in-vivo, ISO 24444 / IS 16178) where an SPF is claimed.
- Declaration confirming the absence of medicated / drug actives where the balm is positioned as a cosmetic.
- Microbiological report.
⚗️ Composition & Safety Limits
Regardless of category, the finished cosmetic must respect the composition limits in the Cosmetics Rules, 2020. CDSCO checks these against the heavy-metal report or the manufacturer's undertaking:
- Arsenic (in permitted colours) — not more than 2 ppm, as arsenic trioxide.
- Lead (in permitted colours) — not more than 20 ppm, as lead.
- Other heavy metals (in permitted colours) — not more than 100 ppm as the total of the respective metals.
- Mercury — up to 70 ppm (0.007%) as a preservative in eye-area products only; unintentional mercury not to exceed 1 ppm in all other products.
- Hexachlorophene — prohibited, except in soaps up to 1% w/w with the prescribed caution.
- Lead and arsenic compounds as colourants — prohibited outright.
- Dyes, colours and pigments — only those specified in IS 4707 (Part 1) / IS 4707 (Part 2) and the Tenth Schedule.
Because lip balm is ingested in small amounts, the heavy-metal limits on any colourant are read strictly, and a medicated active (e.g. a lip-repair drug ingredient) takes the product off the cosmetic route.
🏷️ Lip Balm & Lip Care Label Requirements
In addition to the general Chapter VI requirements, lip-balm labels are checked for these product-specific points:
- Directions for use; shade name for a tinted balm.
- SPF value consistent with the test report where claimed.
- Registration Certificate number preceded by “RC” or “Reg. Cert. No.”.
- Net content by weight.
⚖️ When a Lip Balm Becomes a Drug
A moisturising or tinted lip balm is a cosmetic. It becomes a drug where it carries a medicated active or a therapeutic claim — a "medicated" lip balm that treats cold sores, or a lip product with a pharmacological active, is a drug needing a Form 10 import licence, not a cosmetic. A sunscreen lip balm stays cosmetic but must carry the SPF evidence.
Keep the balm positioned as lip care, confirm there is no drug active, map any tint to IS 4707 (Part 1), and hold the SPF report where a sun-protection number is claimed.
🛠️ Step-by-Step Registration Process
- Classify the productConfirm the article meets the definition of a cosmetic under Section 3(aaa) and is not a drug, then map it to the correct Fourth Schedule category — this drives both the fee and the certificate scope.
- Appoint the Authorised Indian AgentExecute the authorisation in the First Schedule format, signed jointly by manufacturer and agent on every page, then notarised and apostilled (Hague states) or attested by the Indian Embassy.
- Assemble the technical dossierIngredient list with percentages, specification and method of testing, finished-product test reports, inner and outer labels, GMP / ISO 22716 evidence and the Free Sale Certificate.
- Align the label to Chapter VIIndian labelling is one of the top rejection reasons. India-specific content may be stickered onto the unit pack at a bonded warehouse before clearance.
- Pay the fee on BharatkoshCompute the category, site and variant fees, pay online under head 0210041040000-00-1 and retain the acknowledgement receipt for upload.
- File Form COS-1 on SUGAMUpload 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 queriesQueries typically concern apostille defects, Free Sale Certificate scope mismatch, ingredient limits and label non-compliance. Reply within the stipulated period, as each query restarts the effective clock.
- Receive Form COS-2Print the Registration Certificate number on every unit pack, alongside the holder's name and address, before the goods are cleared for sale.
💰 Government Fees
CDSCO cosmetic registration is priced under the Third Schedule and paid category by category, not as a single flat licence. The headline components are:
Each cosmetic category
USD 1,000 for the grant or retention of the Registration Certificate, per Fourth Schedule category.
Each additional category
USD 1,000 for every further category added to the same application.
Each variant
USD 50 for each shade, fragrance or formulation variant declared.
Each manufacturing site
USD 500 for every overseas manufacturing premises covered.
Fees are paid online through the Bharatkosh gateway under head of account 0210041040000-00-1, and the acknowledgement receipt is uploaded with the application. A duplicate certificate is USD 200, permission for a novel ingredient not previously used in India is USD 500, and inspection of an overseas manufacturing site, if ordered, is a further USD 5,000.
⏱️ Timeline & Validity at a Glance
A complete, well-drafted application is typically cleared in about four to six months. The single biggest lever on that timeline is the quality of the first filing: every query CDSCO raises effectively restarts the clock, so a dossier that pre-empts the common objections is worth far more than one filed quickly and corrected later. The certificate is valid for five years and should be re-registered before expiry — an application filed after lapse is treated as a fresh registration, and a retention fee keeps the certificate alive across the term.
⚠️ Where Lip Balm & Lip Care Applications Get Queried
Most lip-balm queries concern medicated claims, colour and SPF:
- A medicated active or a treatment claim (e.g. cold-sore treatment) that converts the product into a drug.
- A tint using a CI number not on IS 4707 (Part 1).
- An SPF printed higher than the tested value, or claimed without an accredited report.
- Variants (flavours, tints) under-declared for the USD 50 variant fee.
🔗 Related Approvals Alongside CDSCO
CDSCO registration rarely travels alone. Depending on the product and the importer, plan for these adjacent approvals in parallel, because any one of them can hold a consignment at the port even when the CDSCO certificate is in order:
- Importer-Exporter Code (DGFT) — mandatory for any importer of record, obtained before the first consignment.
- LMPC registration (Legal Metrology) — importers of pre-packaged commodities register under the Legal Metrology (Packaged Commodities) Rules, 2011 and carry MRP, net quantity, importer details, country of origin, consumer-care details and date of import on the pack.
- Wholesale licence (Form 20B / 21B) — where the Indian agent also distributes drugs alongside cosmetics.
- Drug import licence (Form 10) — where the product contains a pharmacologically active ingredient or makes a therapeutic claim, it is a drug, not a cosmetic, and this route replaces COS-1.
✅ Post-Approval Obligations
The certificate is the start of an ongoing compliance duty, not the end of it. After grant, the registration holder must:
- Print the Registration Certificate number on every unit pack, with the name and address of the certificate holder.
- Report any change in labelling, composition, testing or specification within 30 days, with an undertaking of continued compliance with the Ninth Schedule standards.
- Report any market withdrawal, regulatory restriction, cancellation of authorisation or not-of-standard-quality finding in any country where the product is sold, and stop dispatch and marketing immediately.
- Allow the Licensing Authority to draw samples for testing and to inspect the overseas manufacturing premises.
- Track BIS standard revisions — a new or amended Indian Standard becomes mandatory six months after publication.
- Diarise re-registration well before the five-year expiry.
❓ Frequently Asked Questions
Is CDSCO registration mandatory for imported lip balm?
Yes. Lip balm and lip care are Fourth Schedule lip-care 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 Indian Standard applies to lip balm?
IS 10284 for lip salve. The CoA is drawn against it, with colour and heavy-metal declarations for a tinted balm.
When is a lip balm a drug rather than a cosmetic?
When it carries a medicated active or a therapeutic claim — for example a cold-sore treatment. A moisturising or tinted balm, or a sunscreen balm with SPF evidence, stays a cosmetic.
Does a tinted lip balm need colour declarations?
Yes — every colour by CI number against IS 4707 (Part 1) and the Tenth Schedule, plus a heavy-metals report, because lip products are partly ingested.
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.
Lip Balm & Lip Care Import Registration, Handled End to End
Global Approbation manages the complete CDSCO cosmetic registration for imported lip balm & lip care — classification, standard mapping, CoA and label review, dossier assembly and query response — so your first consignment clears without avoidable delay.
Talk to Our CDSCO Team Global Market Access