INDIAN REGULATORY REQUIREMENTS FOR LABELING OF COSMETICS , IMPORTANCE OF LABELING , LABELING REQUIREMENTS , Common or generic name of the product. , Product function , Use instruction , Name & address of Manufacturer , Country of manufacture , Manufacture Date , Expiry date , Net Quantity , Retail Sale Price , Storage condition , Barcodes , Batch number , Warning or Caution if hazard exists , Manufacturing License Number , Ingredients , Registration Certificate Number (RCN) , Consumer Care Details , Using Stickers , Brown/Red or green dot , Not a standard pack size under Legal Metrology(Packaged commodities) Rules

1. INDIAN REGULATORY
REQUIREMENTS FOR
LABELING OF
COSMETICS

2. DEFINITION
Label means a written; printed; or graphic
matter on the container or the wrapper of
outer package

3. LABELING IN INDIA
INTRODUCTION
All labels of a cosmetics should conform as per the
specifications under the Drugs and Cosmetics Rules 1945.
That no person sell or distribute any cosmetics unless it is
labelIed in accordance with the Rules (Rule 95 of D&C
Act).

4. LABELING - OBJECTIVE
To provide information for the consumers to
make an informed choice
To assist the regulators in carrying out
surveillance activities

5. IMPORTANCE OF LABELING
The safe use of all medicines depends on users reading
the labeling and packaging carefully and accurately and
being able to assimilate and act on the information
presented.
All labels must be clear and concise and must bear all
necessary information regarding the safe use of a product.

6. LABELLING REQUIREMENTS
1) Common or generic name of the product.
2) Product function
3) Use instruction
4) Name & address of Manufacturer
5) Country of manufacture
6) Manufacture Date
7) Expiry date
8) Net Quantity
9) Retail Sale Price
10)Storage condition
11)Barcodes

7. 12) Batch number
13) Warning or Caution if hazard exists
14) Manufacturing License Number
15) Ingredients
16) Registration Certificate Number (RCN)
17) Consumer Care Details
18) Using Stickers
19) Brown/Red or green dot
20) ‘Not a standard pack size under Legal Metrology(Packaged
commodities) Rules, 2011’

8. 1) COMMON OR GENERIC NAME
OF THE PRODUCT.
Name of Cosmetics on both inner and outer labels
The name given to a cosmetic product, which may be
an invented name, together with a trade mark or the
name of the manufacturer.

9. 2 ) PRODUCT FUNCTION
The function of the product must be clearly indicated,
e.g.: hand moisturizer as to prevent any misuse.

10. 3 ) DIRECTION FOR USE

11. 4) NAME & ADDRESS OF
MANUFACTURER
On both inner and outer labels
“Manufactured by….” Or “Packed by…”
Complete address of the premises where the product was
manufactured
 Additionally, name and address of the packer or/and
importer in relevant cases.

12. 5 ) COUNTRY OF MANUFACTURE
Add the mention: “Made in country” unless the product
is made in Europe in which case such mention is not
mandatory.
Note: the “Made in” expression does not need any
translation.
Example:
Made in India , made in china, Manufactured in USA
Country of origin: Thailand

13. 6) MANUFACTURE DATE
Date of Manufacture, or Pre-packed or Import of
commodity
Rubber stamp can be used, but without overwriting.
 On both inner and outer label.

14. 7) EXPIRY DATE
 “Use before … (Month and year)”- has to be labelled
or the Expiry date.
On both inner and outer label.

15. 8) NET QUANTITY
 Standard unit of weight or measure
 On outer Label.
 Weight of wrappers/containers-excluded.
If package capacity is less than 10 cubic cm or less –
quantity declaration to be made on tag, card, tape etc.
 No Declaration required:- If the net content of the
package of perfume, toilet water or the like, is less than
60 ml or 30 gm.

16. 9) RETAIL SALE PRICE
For reducing MRP, a sticker with revised MRP may be
affixed inclusive of all taxes.
But such sticker should not cover the MRP declaration
by manufacturer or packer on the package.

17. 10) STORAGE CONDITION
Store in cool place
 protect from light

18. 11) BARCODES
“It is an optical machine readable representation of
data, which shows data about the object to which it
attaches”

19. 12 ) BATCH NUMBER
Batch number not required- If cosmetic is of 10 grams
or 25 milliliters or less.
Soaps- instead of batch number, the month and year
of manufacture may be given.

20. 13) WARNING OR CAUTION IF HAZARD
EXISTS
On the inner label.
Cosmetics may be hazardous to consumers must be bear
appropriate label warnings. e.g.: Flammable cosmetics such as
aerosols, cosmetic manufacturers market cosmetic products
that do not contain ethyl alcohol as “alcohol free”.

21. 14) MANUFACTURING LICENSE
NUMBER
In India , to manufacture cosmetics , it is required to get a
mfg. Lic. No as per drug & cosmetics act ,1945 .

22. 15) INGREDIENTS
Ingredients present in concentration of more than 1% -
listed in the descending order of weight/volume.
Colorants may be listed in any order, after all the
other ingredients.

23. 16) REGISTRATION CERTIFICATE
NUMBER (RCN)
Only the label of imported cosmetics should bear RCN
of the product.
 The name and address of the registration certificate
holder for marketing the said product in India.

24. 17) CONSUMER CARE DETAILS
Name, address, telephone number, E-mail address of
the person who can be contacted in case of consumer
complaints.

25. 18) USING STICKERS
Not permissible for altering or making declaration.
Except in the case of reducing MRP, but same should
not cover the MRP declaration made by the
manufacturer/ packer.

26. 19) BROWN/RED OR GREEN DOT
For the package of soap, shampoos, tooth pastes and
other cosmetics and toiletries.
Non-Vegetarian origin- Brown dot
 Vegetarian origin- Green dot.

27. 20) ‘NOT A STANDARD PACK SIZE UNDER
LEGAL METROLOGY(PACKAGED
COMMODITIES) RULES, 2011’
Specific Cosmetics should be packed in the standard
quantities as mentioned in the Second Schedule of the
said rule.
 If packed in size other than that prescribed in the
schedule, then it should be prominently labeled in the said
manner.
Value Based packages4 can be sold without complying
with the Second Schedule.

30. On both the inner & outer labels:-
a). Name of the cosmetic.
b). Name of the manufacturer and complete address of
the premises of the manufacturer where the cosmetic
has been manufactured .

31. On the outer label:
a). A declaration of the net contents expressed in terms of
weight for solids/ semi solids, fluid measure for liquids.
(Note: In the case of package of perfume, toilet water or the
like, the net content which does not exceed 60 ml or any
package of solid or semi solid cosmetic where the net
content doesn’t exceed 30 gms, the statement of net
content need not appear).
b). The names of ingredients in the order of percentage of
content.

32. On the inner label:
a) Where a hazard exists, adequate directions for safe
use, warning, caution or special direction required to
be observed by the consumer, statement of the
names and quantities of the ingredients that are
hazardous or poisonous.
b) The names of ingredients in the order of percentage
of content.
-Batch number preceded by the letter “B”
-Manufacturing license number preceded by the letter
“M.”

33. LIST OF STANDARD REFERENCE FOR
COSMETIC INGREDIENT
NOMENCLATURE
1. International Cosmetic Ingredient Dictionary
2. British Pharmacopoeia
3. United States Pharmacopoeia
4. Chemical Abstract Services
5. Japanese Standard Cosmetic Ingredient
6. Japanese Cosmetic Ingredient Codex

34. RELABELING : GUIDELINES
Scope
Relabeling- Involves removal, alteration ,
replacement , or overstickering of original label
without opening of the immediate packaging or
tampering with the contents.

35. COMPANY’S RESPONSIBILITIES
Premise/ Re-labeling Area
Must be of reasonable size.
Must be clean and free from any pests.
Personnel
Trained and able to conduct re-labeling
exercise as directed.
Good personal hygiene

36. Process
Appropriate re-labeling procedures.
Systematic documentation*.
Use appropriate equipment and necessary
items for re-labeling exercise.
COMPANY’S RESPONSIBILITIES