Regulatory Guide: Cosmetic labeling requirements in Mexico
Labeling represents one of the final stages in cosmetic product development, but it is also one of the most critical from a regulatory perspective.
NOM-141-SSA1/SCFI-2012 establishes the sanitary and commercial information that must appear on the labels of prepackaged cosmetic products, whether domestically manufactured or imported, before they are marketed in Mexico.
Conducting a regulatory review of product labeling helps identify opportunities for improvement, prevent regulatory observations, and avoid modifications that could delay commercialization.
General Labeling Requirements
The information displayed on a cosmetic label must:
be provided in Spanish, although additional languages may also be included;
be clear, truthful, legible, and indelible;
use characters that are easy to read and contrast with the background; and
remain available and legible throughout the product's shelf life.
Depending on the packaging configuration, the required information may be distributed between the Principal Display Panel (PDP) and other areas of the primary or secondary packaging.
Essential Label Information
The Principal Display Panel (PDP) is the area of the package that consumers immediately recognize when viewing the product. It must contain the essential information needed to identify the cosmetic.
Brand Name
The commercial name under which the product is marketed.
Product Identity
The product identity should clearly describe the nature of the cosmetic product, for example:
Moisturizing Facial Cream
Shampoo for Dry Hair
Shower Gel
The product identity must not be misleading or imply therapeutic, preventive, or curative properties.
Net Contents
The net contents must be declared using the International System of Units (SI) and the appropriate symbols, for example: g, kg, mL, L
Sanitary and Commercial Information
In addition to the essential product information, the label must include the following elements.
Responsible Party
Domestic Products
Name (or corporate name) and address of the manufacturer or responsible party.
Imported Products
Name and address of the importer established in Mexico, together with the country of origin indicated by statements such as:
Made in...
Product of...
Manufactured in...
as applicable.
Ingredient Declaration
Ingredients must be declared using a nomenclature recognized by the applicable regulations. In practice, the cosmetic industry primarily uses the International Nomenclature of Cosmetic Ingredients (INCI), as it provides standardized ingredient identification worldwide.
The ingredient declaration should:
list ingredients in descending order of concentration at the time of incorporation;
allow ingredients present at concentrations below 1% to be listed in any order after those present at 1% or more;
identify color additives using their Colour Index (CI) numbers, when applicable; and
declare fragrance mixtures as Perfume or Parfum, as appropriate.
Directions for Use
When necessary, the label must include directions that enable the product to be used safely and correctly.
This is particularly relevant for products such as sunscreens, hair dyes, bleaching products, hair straighteners, permanent wave products, depilatories, and other cosmetics whose safe use depends on proper application.
Warnings
Where applicable, the label must include the warnings necessary to promote safe use.
Examples include:
For external use only.
Avoid contact with eyes.
Keep out of reach of children.
Certain cosmetic categories require additional mandatory warning statements under NOM-141.
Batch Identification
Every cosmetic product must bear a batch number or code that enables the product to be identified and supports traceability throughout distribution and commercialization.
Product Claims
Claims used to describe a cosmetic product must be consistent with its intended cosmetic purpose and must not mislead consumers.
Labels should not include therapeutic, preventive, or curative claims, nor any statements that could change the regulatory classification of the product.
Before incorporating marketing claims into a label, it is advisable to verify that they are consistent with the cosmetic category and supported by the applicable regulatory framework.
Considerations for Imported Products
Imported cosmetic products must comply with the same sanitary and commercial labeling requirements applicable to products manufactured in Mexico.
If the mandatory information is not originally provided in Spanish, it may be added by means of a supplementary label (stick-on label or overlabel) before the product is marketed in Mexico, provided all applicable regulatory requirements are met.
Reviewing labeling before importation helps minimize corrective actions and facilitates regulatory compliance.
Conclusion
Well-designed labeling not only supports compliance with NOM-141-SSA1/SCFI-2012, but also helps ensure that cosmetic products reach the Mexican market with clear, consistent, and compliant information.
Performing a regulatory review before printing or importing labels allows companies to identify necessary adjustments early, streamline commercialization timelines, and reduce the likelihood of observations during regulatory inspections.
FAQ
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Compliance with NOM-141-SSA1/SCFI-2012 involves more than simply including the required information. It is also important to verify that all mandatory information is presented correctly, that product claims are consistent with the cosmetic nature of the product, and that the label meets the applicable formatting and presentation requirements.
Conducting a regulatory review before printing the label or placing the product on the Mexican market helps identify potential issues early and facilitates compliance with the applicable regulations.
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The ideal time to review labeling is before the artwork is approved for printing or before the importation process begins.
Including a regulatory labeling review during the final stages of product development—but prior to commercialization, allows potential issues to be addressed more efficiently, helping to avoid label reprints, delays, and unnecessary costs.
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Not necessarily. While many markets share similar labeling principles, Mexico has specific sanitary and commercial labeling requirements that must be met before a cosmetic product can be marketed.
Before introducing a product into the Mexican market, it is advisable to verify that the label includes all information required by NOM-141-SSA1/SCFI-2012 and that product claims, ingredient declarations, and responsible party information comply with the applicable Mexican regulations.
Written by:
Tania Ramírez
Regulatory Affairs Analyst specializing in cosmetics and dietary supplements. Expert in ensuring regulatory compliance across ingredients, labeling, and marketing claims for successful COFEPRIS submissions and licensing.
About IPS
Ensuring compliance with NOM-141 before launching a product or beginning the import process can help identify potential regulatory issues before they impact commercialization. At IPS, we assist manufacturers, importers, and distributors with technical label reviews, claims assessment, regulatory product classification, and compliance evaluations to support a smooth and successful entry into the Mexican market
Contact us at info@insumosparasalud.com to learn more about our specialized regulatory services for cosmetic products.
