Cosmetic labeling manual fda

Or Is It Soap? How should products be labeled if they are both drugs and cosmetics? If a product is an over-the-counter OTC drug as well as a cosmetic, its labeling must comply with the regulations for both OTC drug and cosmetic ingredient labeling [21 CFR All labeling information that is required by law or regulation must be in English.

The only exception to this rule is for products distributed solely in a U. For information on dual declaration of ingredients, see Ingredient Names. What labeling information is required? What about therapeutic claims? What languages are acceptable? Customs and Border Protection "Made in U. Some labeling terms to know Before proceeding with a discussion of labeling requirements, it is helpful to know what some labeling terms mean: Labeling.

This is the part of the label most likely displayed or examined under customary conditions of display for sale [21 CFR Off-package ingredient labeling is permitted if the cosmetic is held in tightly compartmented trays or racks, it is not enclosed in a folding carton, and the package surface area is less than 12 square inches 21 CFR The ingredients must be declared in descending order of predominance.

Color additives 21 CFR The ingredients must be identified by the names established or adopted by regulation 21 CFR Cosmetics which are also drugs must first identify the drug ingredient s as "active ingredient s " before listing the cosmetic ingredients 21 CFR All label statements required by regulation must be in the English language and must be placed on the label or labeling with such prominence and conspicuousness that they are readily noticed and understood by consumers under customary conditions of purchase 21 CFR Cosmetics which may be hazardous to consumers when misused must bear appropriate label warnings and adequate directions for safe use.

The statements must be prominent and conspicuous. Some cosmetics must bear label warnings or cautions prescribed by regulation 21 CFR Cosmetics in self-pressurized containers aerosol products , feminine deodorant sprays, and children's bubble bath products are examples of products requiring such statements.

If the safety of a cosmetic is not adequately substantiated, the product may be considered misbranded and may be subject to regulatory action unless the label bears the following statement: Warning--The safety of this product has not been determined.

Liquid oral hygiene products e. A package is considered tamper resistant if it has an indicator or barrier to entry e. The indicator must be distinctive by design breakable cap, blister or appearance logo, vignette, other illustration to preclude substitution. The petitioner is informed of the agency's final determination in writing. The agency's final decision may be challenged in the courts under 5 U. If suit is brought within 30 days after such determination, FDA will not disclose the records involved until the matter is finally determined in the courts.

If suit is not brought within 30 days and the petitioner does not withdraw the records for which a request for confidentiality has been denied, the records involved will be made part of FDA's files and will then be available to the public upon request. It should be noted that until the agency has completed its determination that the identity of a cosmetic ingredient is a trade secret, the cosmetic product in question may not bear the label statement "and other ingredients" in lieu of a declaration of the identity of the ingredient for which confidentiality has been requested.

The phrase "and other ingredients" may be used on the label only after an ingredient is accepted by FDA as exempt from public disclosure or, when confidentiality has been denied, if suit is brought within 30 days after a final determination that the ingredient in question is not a trade secret.

The established name of any active drug ingredient and the quantity, kind, and proportion of any alcohol, in compliance with Sec. A product intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance is a cosmetic.

If this product claims to accomplish these deeds through physiological activity or by changing the structure of the skin, it is also a drug. The product categories "drug" and "cosmetic" are not mutually exclusive.

This is recognized in sec. If a cosmetic is also a drug, the label must list first the established name of the drug ingredient s and the quantity, kind and proportion of any alcohol, in compliance with sec. This hypothetical aerosol antiperspirant formulation illustrates on the right side the correct label declaration of the ingredients of a cosmetic which is also a drug. The active drug ingredient aluminum chlorohydrate is identified as "Active Ingredient" in accordance with sec.

The remaining ingredients may be identified as "Cosmetic Ingredients" as shown or as "Other Ingredients. Listed after the declaration of other color additives and after the phrase"May contain". A color additive s that is added to a cosmetic during manufacture for the purpose of color matching may be declared on the label of each batch or lot even if not present in each.

The color additive sometimes added for color matching is listed after the declaration of other color additives, or at the end of the declaration, and after the phrase "May Contain. Definition: Any processing aid added and removed or converted to a declared ingredient or Any ingredient of another ingredient or processing aid present at an insignificant level and having no technical or functional effect.

A substance added during manufacture and removed from the cosmetic in accordance with good manufacturing practices before the cosmetic is packaged in finished form.

Example: Filter aid. A substance that is added during manufacture of a cosmetic, is converted to an ingredient declared on the label, and does not significantly increase the concentration of the declared ingredient. Example: Sodium hydroxide added to a sodium stearate and stearic acid-containing cosmetic. A substance added to a cosmetic during manufacture for its technical effect in processing but present in the finished cosmetic at an insignificant level and not having any technical or functional effect in that cosmetic.

Example: Defoaming agent. A substance added to a cosmetic as a component of a cosmetic ingredient and having no technical or functional effect in the finished cosmetic. Example: Preservative of a raw material added to a cosmetic as an ingredient at a concentration which reduces the preservative to a level at which it is no longer effective. Examples: Gift set of makeup assortment Hair coloring kit or home permanent Declaration: On outside retail package only if components are not customarily sold individually.

The ingredients of the units of cosmetics marketed as multiunit or multicomponent packages must be declared on the label of the outside container. They must also be declared on the labels of the inside containers of the units if the inside containers are customarily separated from the outer container for individual retail sale.

Examples: A shade assortment of eye shadows in an eye make-up kit or a gift set consisting of a lotion, powder and toilet water in a gift box. Examples: A hair coloring kit consisting of dye solution and hydrogen peroxide or a permanent wave set consisting of thioglycolate solution and sodium bromate solution.

Labeling surface area Less than 12 square inches Over 12 square inches Branded shade lines Single units and assortments. For the purpose of cosmetic ingredient labeling and to take advantage of provisions for consolidated ingredient listing in place of somtimes repetitive listing of ingredients unit by unit, a distinction must be made between packages containing:.

Products of similar composition and intended for the same use in a package with a total surface area available for labeling of 12 square inches or more.

Example: Two toilet waters of different fragrance or color in gift set. Products of similar composition and intended for the same use in a package with a total surface area available for labeling of less than 12 square inches. Example: Eye shadows of different color in a compact case.

Products that are single units or assortments of a branded shade line. A branded shade line is a series of products of similar composition, intended for the same use, and sharing a common label with the same brand name. Example: A shade line of lipsticks. Alternate Declaration Single composite list of color additives with statement that list pertains to all products.

The package of an assortment of dissimilar products, i. A conventional ingredient declaration in which each ingredient of each product is identified under an appropriate product heading, or. An alternate ingredient declaration in which the color additives of all products of the assortment are integrated into a single composite list that indicates that the list pertains to all products.

Please note that if the units of an assortment are customarily separated from the outer package for retail sale, the ingredients must also be declared on the label of each inside unit. This example of a hypothetical assortment of dissimilar products consisting of a toilet water and a dusting powder illustrates on the right side the alternate ingredient labeling option in which all color additives are declared in a single composite list.

The declaration advises that the color additives pertain to both products. If, for example, Red 40 or Blue 1 were present in both products, they would have to be listed only once in the declaration. Ingredients common to all products listed in cumulative descending order of predominance or according to paragraph f , and.

An assortment of products of similar composition and intended for the same use in a package with a total surface area available for labeling of 12 square inches or more as, for example, two toilet waters of different fragrance or color in a gift set, may bear either:.

The ingredients other than color not common to all products, identified by the products in which they are present, followed by. The color additives of all products without identification of products in which they are present. An assortment of products of similar composition and intended for the same use in a package with a total surface area available for labeling of less than 12 square inches as, for example, several eye shadows in a compact, may bear either:.

This example of an assortment consisting of two similar hypothetical eye shadow formulations demonstrates the optional ingredient declarations for packages with a total surface area available for labeling of 12 square inches or more center and for packages with a total surface area available for labeling of less than 12 square inches right side.

On the left side are shown two conventional ingredient declarations, each representing one shade. In the center is shown the integrated ingredient declaration for the two shades in the package with 12 square inches or more of available labeling area.

Note that the ingredients other than color not common to all products are listed after the ingredients that are common and are identified by the products in which they are used. On the right side is shown the integrated ingredient declaration for the two shades in the package with less than 12 square inches of available labeling area. Note that the ingredients not common to all formulations need not be identified by the products in which they are used.

Individually packaged, or assortments of eye or facial makeup cosmetics or nail enamels bearing the same name.

Example: A line of lipsticks with the same brand name. Example: Several compacts with the same name and label, each containing several eye shadows.

According to Ingredients common to all products, in cumulative descending order of predominance. An alternate ingredient declaration listing all ingredients for all branded shades in the cumulative order shown below. In this case, each shade of a branded shade line or each package of a branded shade line assortment bears the same ingredient declaration.

This example of a hypothetical shade of a line of lipsticks bearing the same brand name illustrates three common errors found in cosmetic ingredient declarations, namely:.

The compounds of such mixtures must be separated, the " and " omitted, and the components treated as individual ingredients for labeling purposes. See "Mica and Titanium dioxide and Iron oxides. Many labels list all color additives of a shade line after the phrase "May contain. The ingredients other than colors which are not included in all shade formulations must be identified as to the shades in which they are present. Cosmetics ordered by and delivered to consumers through the mail without involvement of an intermediary sales agent.

Direct mail cosmetics may utilize off-package ingredient labeling as an alternative to the declaration of ingredients on an information panel. For the purpose of cosmetic ingredient labeling, direct mail cosmetics are defined as cosmetics ordered by mail and delivered to consumers through the mail without the involvement of an intermediary sales agent.

Cosmetics sold to consumers through "door-to-door" salespersons are not considered direct mail cosmetics even though they may be delivered to consumers directly by mail. Labeling that accompanies and specifically relates to the cosmetic s mailed, e. Labeling furnished to each consumer for personal use and from which cosmetics are ordered through the mail, e. If the ingredients of cosmetics distributed to consumers by direct mail are made available through off-package labeling, the following requirement must be met:.

The mail order distributor must promptly mail a copy of an ingredient declaration to any person requesting it. The ingredient declarations must be conspicuous and presented in a way that the consumer can readily associate each ingredient declaration with each cosmetic.

Off-package Ingredient Labeling Qualifying Conditions. The declaration of ingredients in labeling accompanying a cosmetic, i. The following are resources on cosmetic label claims, expiration dating, ingredient names nomenclature , and related regulatory and enforcement information. Proper labeling is an important aspect of putting a cosmetic product on the market. Here's where to learn about labeling requirements:.