Product Label Content? Labeling your products…are you doing it right? Do you have everything on there that you’re supposed to have? Where is it supposed to go exactly? Do you need to list that? Is it the right size? In the United States, as in most countries around the world, there are very specific requirements for the labels of all cosmetic products. In this article we are going to cover the label components that are required on every cosmetic product sold in the US, Canada, Japan, Australia, Great Britain, all of the EU member countries, and many others. In the US, the applicable law is the Fair Packaging and Labeling Act ("FPLA"). The FDA created (and is the enforcement arm for) the regulations implementing the FPLA. Many states also have comparable laws and regulations which are enforced at the state level. In other countries there are comparable laws and regulations, which are implemented on a national and/or local level. EU member states are subject to both the EU cosmetic law and regulations as well as those implemented in the individual countries. Principal Display Panel Every product has a “front” that is meant to face the customer. In the regulations, this front panel is called the “principal display panel.” It’s not actually the label, but rather the space on the container on which you place information. For a rectangular package, it is one whole large side; for a cylindrical container, it is 40% of the total surface (the 40% that faces the consumer). Two pieces of information are required on the principal display panel of every cosmetic product sold: the product identity and the net contents. Product Identity The product identity is what the product is or what it is used for and is required so the consumer knows what they are considering purchasing. Generic terms such as “soap” or “lotion” are normally used to state the identity. In the US, whimsical names or even images are considered sufficient if that would clearly communicate the identity/use of product. Net Contents The net contents (that is, the amount of product excluding any containers or packaging) is required so the consumer knows how much is contained in the product they are considering purchasing. In all countries, the net contents must be stated in metric; in the US, the net contents must also be stated in “inch/pound” measurements. Solid or semi-solid products are those that can’t be poured or pumped, such as soap, thick creams, lotion bars or scrubs. The net contents of solid or semi-solid products must be stated by weight (grams and ounces or, for large packages, kilograms and pounds). Fluid products are those that can be poured or pumped, such as liquid soap, lotions or sprays. The net contents of fluid products must be stated by volume (milliliters and fluid ounces or, for large containers, liters and gallons). The amount in the package may never be less than is stated in the net contents; it may be more, subject to good manufacturing practices. Those who make soap should be careful to ensure that evaporation after packaging does not render the product weight less than the stated amount when it is purchased by the consumer. For any product larger than about 2 ounces (60 grams or 60 mL), the net contents must be placed parallel tothe bottom and in the bottom third of the front of the package. The text size must be at least 1/8 inch in height, measuring the height of the lower-case “o” in the font used. Generally, that’s much larger text than most graphic designers would prefer. The text can be smaller on smaller packages, and there are exceptions to the placement for very small (1/8 oz) packages. Informational Panels All surfaces of the package other than the principal display panel are considered informational panels.Two pieces of information are required on the informational panels of any cosmetic product sold: the name and address of the “responsible party” and a declaration of the ingredients in the product. Directions for safe use should also be included if there is any question on the use of the product. Responsible Party’s Name and Address All countries require the name and address of the responsible party. In countries that mandate cosmetic manufacturers and/or cosmetic products be registered and/or approved, the “Responsible Party” is generally the person or business under which the manufacturer is registered. In the United States, the name and address must be of the legal entity that manufactures or distributes the product. If it is not the actual manufacturer then it must be prefaced by “Manufactured for …”or “Distributed by …” as applicable. Note that this is the legal business name; if the business is a sole proprietorship and no fictitious name or “doing business as” has been filed, then the person’s name would be the legal name of the business and would be required on the label. The street address must be the actual physical location at which the business is located; that is, where the “brains” of the business are located and where decisions are made. The FDA has stated more than once that a Post Office box or a mail forwarding service (public mail box) is not acceptable as the street address. However, for those concerned about a street address on the label, it may be omitted if it is listed in a “phone or city directory” under the business name. When the regulations were first written, both printed phone and city directories were prevalent. Now that they are infrequently published in paper form, the FDA has clarified that a listing in an “online phone directory” which includes the street address would be acceptable. The FTC, which implements the Fair Packaging and Labeling Act for products other than food, drugs and cosmetics, has gone so far as to say that if a business street address is included in any “readily accessible, widely published and publicly available resource” (which includes a website) then the street address may be omitted from the label. While the FTC’s regulations do not apply to cosmetics, it does give an indication of how the law has been interpreted for other products and may at some point be interpreted for cosmetics. The business name, city, state and zip code must be provided in all cases. Ingredient Declaration A declaration of all the ingredients in the cosmetic product must be included on the cosmetic label. Listing all the ingredients in descending order of predominance is always correct. As an alternative, one could list all the ingredients present at more than 1% in descending order of predominance, followed by the ingredients present at 1% or less in any order, then followed by the color additives in any order and regardless of amount. Note that in order to qualify for placement at the end of the ingredient declaration, the color additive must be one which is approved for use in cosmetics. This alternative listing is acceptable in all countries. The names by which ingredients are listed should be those which have been published in the Cosmetic Ingredient Dictionary and accepted as the INCI (International Nomenclature of Cosmetic Ingredients) name. HOWEVER, in the United States, for botanical ingredients the common English name should be used rather than the Latin name listed in INCI. The Latin name may be included in parentheses if desired. In countries other than the US, the Latin name as given in INCI is generally required for botanical ingredients. In the EU countries, certain chemicals or essential oil components must be disclosed in the ingredient declaration if they are present over specific amounts. Other countries may have similar laws/regulations concerning certain ingredients. US regulations specify that the text size for the ingredient declaration must be at least 1/16” in height (measuring the height of the lower-case “o” in the font used). For very small packages where the total surface area is less than 12 square inches, the text may be reduced to 1/32” in height. The regulations in the US and other countries also contain provisions for changes in the ingredient declaration in other manufacturing and packaging situations, including the possibility that an ingredient may be discontinued or become unavailable, colors used for color-matching between batches and multi-packages of different products. Directions for Safe Use If there is any possibility the consumer may not know how to use the product safely, adequate directions should be included on the package. This is particularly important if there are special steps to using the product or circumstances in which there could be safety issues in its use. Regular bar soap, for example, probably does not require directions for use. A scrub may require brief directions for those unfamiliar with the product and possibly a warning that the tub or shower could become slippery. A face mask kit, with multiple components that must be mixed and an application process that may not be intuitive, would require more detailed and extensive directions. Summary In summary, there are only 4 items that are absolutely required on every cosmetic label, and one item that is frequently (but not always) needed: Identity of the product (what it is) Net contents Business name and address Ingredient declaration Directions for safe use (when needed). Whether you have a graphic designer creating your labels or you make them yourself, when you create a new label, it’s easy to check that all the required components are on the label. Being sure your label is compliant before you invest in printing and packaging can save you money, time and headaches in the long run. This article is brought to you by MarieGale.com, Marie Gale is the author of Soap and Cosmetic Labeling and works to help handcrafters understand the labeling regulations.