Sunscreens and sun-care preparations are cosmetics under the Cosmetics Rules, 2020 and must be registered with CDSCO before import. What sets this category apart is that the Ninth Schedule lists no Indian Standard for sun protection — so the product must instead meet the standards and specifications applicable in its country of origin, plus every requirement of the Cosmetics Rules, 2020.
In practice that shifts the whole compliance burden onto the test reports. CDSCO scrutinises the SPF and UVA data closely and checks that the protection factor printed on the pack matches the tested value, which makes accredited-laboratory reporting the heart of a clean sunscreen application.
📌 Because no Indian Standard applies, your SPF and UVA test reports are the registration. CDSCO checks that the SPF on the pack does not exceed the tested value, and that any “broad spectrum” claim is backed by a UVA report on file.
📋 Is CDSCO Registration Mandatory for Sunscreen & Sun-Care?
Yes. A sunscreen is a cosmetic within the Fourth Schedule category of sun-protection preparations, and import registration is mandatory. The certificate is product-specific and each tinted shade counts as a chargeable variant.
The absence of a Ninth Schedule standard does not make the category lighter-touch — if anything it raises the evidentiary bar, because the country-of-origin standard and the test data must together demonstrate compliance.
📘 The Indian Standard That Applies
No Indian Standard is listed for sun protection. The product must meet the standards and specifications applicable in the country of origin, and the country-of-origin specification must be submitted as part of the dossier.
On top of that, CDSCO expects a suite of performance reports: an in-vivo SPF report (ISO 24444 or equivalent) from an accredited laboratory, a UVA protection report (ISO 24443 in-vitro, or the PPD method) wherever a UVA or PA rating is claimed, and a water-resistance report (ISO 16217 or ISO 18861) if the product claims to be water resistant.
🗂️ Documents Required for Sunscreen & Sun-Care
Every Form COS-1 application carries the same core set — covering letter; First Schedule authorisation; Part-I of the Second Schedule; 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 that base, this product needs:
- SPF test report — in vivo, ISO 24444 or equivalent, from an accredited laboratory.
- UVA protection report — ISO 24443 (in vitro) or the PPD method — wherever a UVA or PA rating is claimed.
- Water-resistance test report (ISO 16217 or ISO 18861) if a “water resistant” claim is made.
- List of UV filters with exact percentages, cross-referenced against the country-of-origin positive list.
- Photostability and accelerated-stability data.
- Country-of-origin standard and specification, since no Ninth Schedule standard applies.
🏷️ Product-Specific Label Requirements
Sun-care labels are checked closely for correlation with the test data:
- SPF value and UVA rating consistent with the submitted test report — CDSCO checks this correlation directly.
- Directions on the quantity to apply and the reapplication frequency.
- Any “broad spectrum” claim supported by the UVA report held on file.
- The general Chapter VI content — manufacturer, country of origin, batch, expiry and RC number.
🛠️ 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 category under the Fourth Schedule — this drives both the fee and the certificate scope.
- Appoint the Authorised Indian AgentExecute the authorisation in the format of the First Schedule, signed jointly by the manufacturer and the 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 Bharatkosh 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.
- 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 product-family by product-family, 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 of cosmetic 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 by the certificate.
Fees are paid online through the Bharatkosh gateway under head of account 0210041040000-00-1, and the acknowledgement receipt is uploaded with the application. As a worked example, an importer registering one category from a single factory with six shade or fragrance variants would pay USD 1,000 (category) + USD 500 (site) + 6 × USD 50 (variants) = USD 1,800 in government fees, before professional and testing costs. Inspection of an overseas 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.
⚠️ Where Applications Usually Get Queried
Sunscreen queries almost always trace back to the test data or the shade count:
- An SPF value on the pack that is higher than the tested value.
- An SPF report from a laboratory that is not accredited.
- Treating a tinted sunscreen as a single SKU when each shade is a chargeable variant at USD 50.
- A “broad spectrum” claim with no UVA report to support it.
🔗 Related Approvals Alongside CDSCO
Sunscreen import also typically involves:
- Importer-Exporter Code (DGFT) — mandatory for any importer of record, obtained before the first consignment.
- LMPC registration (Legal Metrology) — importers of pre-packaged commodities must 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 drug licence (Form 20B / 21B) — where the Indian agent also distributes drugs alongside cosmetics.
- Drug import licence (Form 10) — if the product contains a pharmacologically active ingredient or carries a therapeutic claim, it is a drug, not a cosmetic, and this route no longer applies.
❓ Frequently Asked Questions
If there is no Indian Standard, what does CDSCO test against?
Against the standards and specifications of the country of origin, plus all requirements of the Cosmetics Rules, 2020. In practice the SPF (ISO 24444) and UVA (ISO 24443) test reports from an accredited lab carry the compliance case, and the country-of-origin specification must be filed.
Can the pack SPF be higher than the tested SPF?
No. CDSCO checks that the SPF printed on the pack does not exceed the tested value. A mismatch is one of the most common sunscreen query triggers.
Is each tinted shade a separate variant?
Yes. Every tinted shade is a chargeable variant at USD 50 and must be declared in the authorisation, the Free Sale Certificate and Form COS-1, even though they share one formula base.
Is CDSCO registration mandatory to import sunscreen & sun-care into India?
Yes. Under Rule 12(1) of the Cosmetics Rules, 2020, no cosmetic may be imported into India unless the product is registered with the Central Licensing Authority. The registration is granted product by product in Form COS-2 and must be in place before the first consignment lands.
Which form and portal are used?
The application is Form COS-1, filed online on the CDSCO SUGAM portal by the overseas manufacturer or, far more commonly, by an Authorised Indian Agent. The approval is issued as an Import Registration Certificate in Form COS-2.
How long does registration take and how long is it valid?
A complete application is usually cleared in about four to six months, and each CDSCO query effectively restarts the clock. The certificate is valid for five years from the date of issue and must be re-registered before it lapses.
Do we need an Indian agent?
Almost every application is filed through an Authorised Indian Agent, appointed on the First Schedule format. The agent carries statutory liability for the product in India even after the power of attorney is withdrawn, so this is a substantive appointment, not a formality.
Sunscreen Import Registration, Built Around Your Test Data
Global Approbation manages CDSCO registration for imported sunscreens — aligning your SPF, UVA and water-resistance reports with the pack claims and the country-of-origin specification — so the absence of an Indian Standard never becomes a weakness.
Talk to Our CDSCO Team Global Market Access