Cosmetic Product Labeling Regulations of the Food and Drug Administration

FDA Cosmetic Product Labeling Requirements - Nicolas and De Vega Law Offices Image

A cosmetic product is one of the health products regulated by the Food and Drug Administration (FDA) of the Philippines. The office of the FDA responsible in regulating cosmetic products and ensuring compliance with the regulatory approvals imposed by the FDA is the Center for Cosmetics Regulation and Research of the FDA.

What is a Cosmetic Product?

Cosmetics mean any substance or preparation intended to be placed in contact with the various external parts of the human body or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odor, and/or protecting the body or keeping them in good condition.

What is a cosmetic product label?

The regulations of the FDA define a label as a display of written, printed, or graphic matter upon, the immediate container of any article and a requirement made by, or under authority of existing laws and FDA regulations that any word, statement, or other information appearing on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or easily legible through the outside container or wrapper.

Labeling means information written or printed or graphic matter on the immediate or outer packaging and any form of leaflets. Immediate packaging means the container or other form of packaging immediately in contact with the cosmetic product and outer packaging means the packaging into which is placed the immediate packaging.

What are the requirements in labeling cosmetic products in the Philippines?

In accordance with ASEAN Cosmetic Directive, the labeling of cosmetic products should comply with the following requirements:

  1. The following particulars shall appear on the outer packaging of cosmetic products or, where there is no outer packaging, on the immediate packaging of cosmetic products:
  • The name of the cosmetic product and its function unless it is clear from the presentation of the product. The name of the cosmetic product means the name given to a cosmetic product, which may be an invented name, together with a trademark or the name of the manufacturer.
  • Instructions on the use of the cosmetic product unless it is clear from the product name or presentation.
  • Full ingredient listing of the cosmetic product. The ingredients must be declared in descending order of weight at the time they are added. Perfume and aromatic compositions and their raw materials may be referred to by the word “perfume”, “fragrance”, “aroma” or “flavor”. Ingredients in concentrations of less than 1% may be listed in any order after those of concentration of more than 1%. Coloring agents may be listed in any order after the other ingredients.

For decorative cosmetic products marketed in several color shades, all coloring agents used in the range may be listed, provided that the terms “may contain” or “+/” be added. The ingredients shall be specified using the nomenclature from the latest edition of standard references.

The List of Standard References to be used for Cosmetic Ingredient Nomenclature are the following:

1. International Cosmetic Ingredient Dictionary;

2. British Pharmacopeia;

3. United States Pharmacopeia;

4. Chemical Abstract Services.

Botanicals and extract of botanicals should be identified by its genus and species. The genus may be abbreviated.

The following, however, are not considered as ingredients and do not need to be listed or included in the full ingredients list: 

a. Impurities in the raw materials used;

b. Subsidiary technical materials used in the preparation but not present in the final products; and

c. Materials used in strictly necessary quantities as solvents, or as carriers, for perfume and aromatic compositions.

  • Country of manufacture.
  • The name and address of the company or person responsible for placing the product on the local market.
  • The contents given by weight or volume, in either metric or both metric and imperial system.
  • The manufacturer’s batch number.
  • The manufacturing or the expiry date of the product in clear terms (e.g. month/year). The date shall be clearly expressed and shall consist either of the month and year or the day, month, and year in that order. The date of minimum durability shall be the date until which this product, stored under appropriate conditions, continues to fulfill its initial function and, in particular, remains in conformity with the guidelines. It should be preceded by the words “expiry date” or “best before”. If necessary, this information shall be supplemented by an indication of the conditions which must be satisfied to guarantee the stated durability. Indication of the expiry date shall be mandatory for cosmetic products the minimum durability of which is less than 30 months.
  • Special precautions to be observed in use, especially those listed in the column “Conditions of use and warnings which must be printed on the label in Annexes __”, which must appear on the label as well as any special precautionary information on the cosmetic products. Member countries may require specific warnings based on local needs for declaration of ingredients from animal origin. In this case: i. There must be a statement (of any format) on the product label signaling the presence of ingredients of animal origin; ii. For ingredients of bovine or porcine origin, the exact animal must be declared;

In cases where the size, shape or nature of the container or package does not permit the particulars laid down above to be displayed, the use of leaflets, pamphlets, hang tags, display panel, shrink wrap, etc. are allowed.

However, the FDA regulations require that following appear on the immediate packaging:

a) The name of the cosmetic product; and

b) The manufacturer’s batch number;

  • The particulars referred to in items a and b should be easily legible, clearly comprehensible and indelible;
  • The items of information listed above should all appear in English and/or National Language and/or a language understood by the consumer where the product is marketed. Certain information in the labels may be in the national language, or a language easily understood by the consumer.

What if the cosmetic product labeling requirements are not complied with?

The cosmetics may be subjected to seizure, as if they are misbranded. Misbranding means misinformation or misleading information on the label or other information materials authorized by the FDA.

What is the penalty for misbranding?

The violator shall be imprisoned from one (1) year but not more than ten (10) years or shall be fined for not less than Fifty thousand pesos (P50,000.00) but not more than Five hundred thousand pesos (P500,000.00), or both, at the discretion of the court.

If the offender is a manufacturer, importer or distributor of any cosmetic product, the penalty of at least five (5) years imprisonment but not more than ten (10) years and a fine of at least Five hundred thousand pesos (P500,000.00) but not more than Five million pesos (P5,000,000.00) shall be imposed.

About Nicolas and De Vega Law Offices

If you need assistance in registration with the Food and Drug Administration, applications for Licenses to Operate, drug, cosmetic, medical device or food registration, assistance in notifications filed under the ASEAN Harmonization Law, or have issues in corporate law, commercial law, corporate or commercial litigation, or civil or other criminal law-related issues,  we can help you. Nicolas and de Vega Law Offices is a full-service law firm in the Philippines.  You may visit us at the 16th Flr., Suite 1607 AIC Burgundy Empire Tower, ADB Ave., Ortigas Center, 1605 Pasig City, Metro Manila, Philippines.  You may also call us at +632 84706126, +632 84706130, +632 84016392 or e-mail us at [email protected]. Visit our website