Please download one of the following templates to design your artwork to:
Standard Packaging ( Airless, jars, toddles)
The following information must appear on the principal display panel:
- An identity statement, indicating the nature and use of the product, by means of either the common or usual name, a descriptive name, a fanciful name understood by the public, or an illustration [21 CFR 701.11].
- An accurate statement of the net quantity of contents, in terms of weight, measure, numerical count or a combination of numerical count and weight or measure [21 CFR 701.13].
The following information must appear on an information panel:
- Name and place of business. This may be the manufacturer, packer, or distributor. This includes the street address, city, state, and ZIP Code. You may omit the street address if it is listed in a current phone directory or city directory [21 CFR 701.12(a)].
- Distributor statement. If the name and address are not those of the manufacturer, the label must say “Manufactured for” or “Distributed by…,” or similar wording expressing the facts [21 CFR 701.12(c)].
- Material facts. Failure to reveal material facts is one form of misleading labeling and therefore makes a product misbranded [21 CFR 1.21]. An example is directions for safe use, if a product could be unsafe if used incorrectly.
- Warning and caution statements. These must be prominent and conspicuous. The FD&C Act and related regulations specify warning and caution statements related to specific products [21 CFR part 700]. In addition, cosmetics that may be hazardous to consumers must bear appropriate label warnings [21 CFR 740.1]. An example of such hazardous products is flammable cosmetics.
- Ingredients. If the product is sold on a retail basis to consumers, even if it is labeled “For professional use only” or words to that effect, the ingredients must appear on an information panel, in descending order of predominance. [21 CFR 701.3]. Remember, if the product is also a drug, its labeling must comply with the regulations for both OTC drug and cosmetic ingredient labeling, as stated above. To learn more, see “Ingredient Names,” “Color Additives and Cosmetics,” “Fragrances in Cosmetics,” and “‘Trade Secret’ Ingredients.”
The quality department at Sarati has implemented a new protocol to review and help advise our clients with their labels/display boxes. We are by no means the final authority but can help provide some guidance, with your permission.
“Proper labeling is an important aspect of putting a cosmetic product on the market. FDA regulates cosmetic labeling under the authority of both the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). These laws and their related regulations are intended to protect consumers from health hazards and deceptive practices and to help consumers make informed decisions regarding product purchase.”
FDA regional offices can be contacted by anyone to help assist with specific questions in regards to labels and claims; we highly recommend utilizing this resource. We understand that the FDA website can be cumbersome to navigate and have provided specific links that help with labeling.
“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. 509 of the FD&C Act.”
Be aware that promoting a product with claims that it treats or prevents disease or otherwise affects the structure or any function of the body may cause the product to be considered a drug.
California Health and Safety Code 25249.6 Required Warning. Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986, was enacted as a ballot initiative in November 1986. The Proposition was intended by its authors to protect California citizens and the State’s drinking water sources from chemicals known to cause cancer, birth defects or other reproductive harm, and to inform citizens about exposures to such chemicals.