Skincare Product Labeling GuideHere is a "skincare product labeling guide" and facts that you will need to know especially if you will expand your line to include the following products.
The FD&C Act defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions.
WHAT GOES ON COSMETIC LABELING
The label statements required under the authority of the FD&C Act must appear on the inside as well as any outside container or wrapper. FP&L Act requirements, e.g., ingredient labeling and statement of the net quantity of contents on the principal display panel, only apply to the label of the outer container.
The principal display panel, i.e., the part of the label most likely displayed or examined under customary conditions of display for sale (21 CFR 701.10), must state the name of the product, identify by descriptive name or illustration the nature or use of the product, and bear an accurate statement of the net quantity of contents of the cosmetic in the package in terms of weight, measure, numerical count, or a combination of numerical count and weight or measure.
If the net quantity of contents is one pound or one pint or more, it must be expressed in ounces, followed in parenthesis () by a declaration of the largest whole units (i.e., pounds and ounces or quarts and pints and ounces). The net quantity of contents may additionally be stated in terms of the metric system of weights or measures.
The name and place of business of the firm marketing the product must be stated on an information panel of the label (21 CFR 701.12). The address must state the street address, city, state, and zip code. If a firm is listed in a current city or telephone directory, the street address may be omitted. If the distributor is not the manufacturer or packer, this fact must be stated on the label by the qualifying phrase "Manufactured for ......"or "Distributed by ......" or similar, appropriate wording.
All cosmetics, whether they are sold on a retail basis to consumers or marketed exclusively for salon or workplace use, are subject to the FD&C Act. This law and regulations enacted under its authority require the cosmetic label to state the name and place of business of the manufacturer, packer or distributor; an accurate statement of the quantity of contents; and any appropriate directions
for safe use and/or warning statements. This information must comply with additional regulatory requirements. It must be prominent and appear in the proper location on the label.
Regulations enacted under the FPLA require ingredients to be listed on the labels of cosmetics sold on a retail basis to consumers -- even if the label states "For professional use only." Consumers can use the ingredient
declaration to identify ingredients they wish to avoid. Ingredients are listed in descending order of predominance, that is, with the ingredient present in
the greatest amount listed at the beginning and those present in the smallest amounts listed at the end. Special rules apply to the ingredient declaration on products that are both cosmetics and over-the-counter drugs. An example of such a product is an anti-dandruff shampoo: A shampoo is a cosmetic, while an anti-dandruff treatment is a drug. Regulations enacted in 1999 require such combination products to have the drug ingredients listed separately as "Active Ingredients," in alphabetical order, followed by the cosmetic ingredients, which are listed as "Inactive Ingredients" in descending order of predominance.
In addition to the immediate label, FDA regulates all cosmetic product "labeling." The definition of labeling includes all written, printed, or graphic matter that appears on the product, its containers, or its wrappers, as well as any such matter that accompanies the product. Typically, materials such as promotional literature, product catalogs, and flyers fit this definition of
labeling. FDA also has considered promotional statements appearing on Internet sites to constitute labeling, especially on those sites where the promoted product can be purchased. However, unfair or deceptive advertising that appears in magazines, in newspapers, or on television generally falls under the authority of the Federal Trade Commission.
Cosmetic firms should refer to FDA's Cosmetic Labeling Manual and the regulations related to cosmetics for more detailed labeling information.
Don't be fooled by claims made for certain cosmetic ingredients. Their presence in the products could be pure puffery because the law does not require cosmetic manufacturers to substantiate performance claims.
"Image is what the cosmetic industry sells through its products," Bailey says, "and it's up to the consumer to believe it or not." (See "Cosmetic Ingredients:
Understanding the Puffery" in the May 1992 FDA Consumer.)
FDA considers the labeling of vitamins in cosmetics a separate issue, however, and does not recognize health claims for them in cosmetics. A product that features a vitamin--for example, vitamin E--must list it by its chemical name TOCOPHEROL on the ingredient list. Listing it as a vitamin in the ingredient statement would give the misleading impression that vitamin E in the product offers a nutrient or health benefit. (Vitamin E is usually added as an antioxidant to prevent chemical deterioration of the product.)
Consumers can get important health and value information by checking the ingredient list. For example, if you need fragrance-free hair spray because you have a sensitivity, a product containing a fragrance--even one that just masks
the chemical odors of the raw materials--could be a waste of money if you can't use it.
Ingredient statements on cosmetics were first required in 1973 under the Fair Packaging and Labeling Act, enforced by FDA. Before then, consumers could only guess what was in a cosmetic product or if the product contained what it
claimed. That requirement is especially valuable today with the industry competition for new ingredients.
The law allows a manufacturer to ask FDA to grant "trade secret" status for a particular ingredient. FDA grants this status under vary limited circumstances and after careful review of the manufacturer's data. The manufacturer must prove that the ingredient imparts some unique property to a product and that the ingredient is not well-known in the industry. If trade secret status is
granted, the ingredient does not have to be listed on the label, but the list must end with the phrase "and other ingredients."
Consumers can also check value by comparing ingredient lists of similar products. Ingredients are listed in descending order, starting with the greatest amount in the product. A lotion with a featured ingredient close to
the beginning of the list, for example, would have more of that ingredient than any other ingredient. A featured ingredient listed close to the end suggests that not much of that ingredient is present.
Anyone curious about an ingredient in a cosmetic can find answers in the International Cosmetic Ingredient Dictionary, published by the Cosmetic, Toiletries, and Fragrance Association. The dictionary provides a complete list of the most widely known cosmetic ingredients and their definitions and trade names. The dictionary, and all other compendia FDA recognizes to name ingredients, are available for reference at many public libraries, or at the Office of the Federal Register, 1100 L St., N.W., Washington, DC 20408.
Cosmetics That Are Also Drugs
Examples of products that are both cosmetics and drugs are shampoos that treat dandruff, fluoride toothpastes to prevent dental decay, and sunscreens and sunblocking cosmetics, including foundations that contain sunscreens. (See "Dodging the Rays" in the July-August 1993 FDA Consumer.)
A product with a drug and cosmetic classification must be scientifically proven safe and effective for its therapeutic claims before it is marketed. If the
product is not, FDA considers it to be a misbranded drug and can take regulatory action.
Misuse of some cosmetic products can cause problems that range in severity from a mild rash to skin burns, or from burning eyes to blindness.
Look for warnings about the consequences of misuse required on products that could be hazardous, in addition to the detailed directions for use that appear
on almost all cosmetics.
For example, products containing halocarbon or hydrocarbon propellants, such as aerosol hairsprays or deodorants, must bear the exact wording:
"Warning--Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal." All cosmetics in self-pressurized containers, such as shaving creams, must have specifically worded warnings against spraying near the eyes, puncturing, incinerating, storing, and intentionally misusing.
"Keep out of the reach of children" is also required for all products in pressurized containers. In the case of products intended for use by children, such as foaming soap, the phrase "except under adult supervision" may be added.
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