Creating Compliant Product Labels

The following 5 points are a very basic guideline when it comes to label compliance for your cosmetic products.

Per the FDA regulation 21 CFR 701.3, the declaration of ingredients except for trade secret ingredients like flavor and fragrance, are to be listed in descending order of predominance. So in other words, the highest percentage to the lowest percentage. Everything under 1% can be listed in any order. A batch document is included with every SKU we ship. This document contains your full ingredients declaration listed in the order required by the FDA. It should be copied verbatim to your label.

Is the ingredient deck on the outermost component of the product and easily readable by consumers? Typically it is on the primary package (the container holding the actual product, such as a bottle) unless there is a secondary package such as a decorative box, and then the ingredient deck must be on the decorative box.

Prominence: The declaration must appear with prominence and conspicuousness so that it is likely to be read and understood (read with ease) by ordinary individuals under normal conditions of purchase. The letters must not be obscured by design, vignettes, background or crowding.

Type Size: Not less than 1/16 inch in height. It may be not less than 1/32 inch in height if the total surface area available to bear labeling (which excludes bottom, shoulder, neck, flange, decorative or sculptured surfaces) is less than 12 square inches. The type size consisting of upper and lower case letters is determined by the height of the lower case letter “o”.

2 – Do you have the correct net quantity of contents on your label? You never want to overstate the amount of product in a package, so it is better to give a slightly lower number that is in the package so you stay at the lower part of the margin of error. Your fill weight is not necessarily going to match the size of your bottle.

Example: A typical 2 oz bottle will hold 2 fluid ounces of liquid product. However, a 2 oz jar will not hold 2 net ounces of sea salt. The term “net” and “net weight” is optional for fluids but required for weight.

a.) Net is used for products that are more solid than liquid, such as soaking salts, scrubs, thick creams, balms, and deodorant sticks. Net Weight 1 OZ / 30 gm -or- 1 oz. net wt. / 30 gm

b.) The term “fluid” (“fl”) is required to distinguish liquid ounces such as body oils, lotions, serums, washes. For a 1 oz bottle of facial serum, you would list: 1.0 FL OZ / 30 ml -or- Net Contents 1.0 FL OZ (30 ml)

3 – Are you making product claims?

FDA guidance is clear: A product intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance is a cosmetic. If a product claims to accomplish these deeds through physiological activity or by changing the structure of the skin, it is also considered to be a drug and must follow the guidelines for a drug. A product can be both a drug and a cosmetic, and the drug guidelines apply.

Cosmetic product cannot reference any type of skin condition. Creative wording becomes key. Cosmetic products cannot heal or cure conditions. They can make you smell good, make you look good, make you feel good and clean you. This applies to any marketing materials, emails, training, videos, ads, and social media posts used to market your product and influence consumers.

4 – Are you using terms or certifications that you are not authorized to use?

Promoting your product as organic’ without paying for use of the official USDA Certified Organic seal and certification is a violation of the law.

“Made in the USA” or using a flag icon, is not permitted unless every ingredient in your product is sourced from the US. So yes, the products you buy from us are ‘made’ here in Ohio but they don’t meet the “Made in the USA” guidelines unless every ingredient comes from the US. Giving the impression your products are “American Made” when it doesn’t meet the definition, is against the guidelines.

Cruelty-free logos or images (i.e. Leaping Bunny) are regulated certifications and you must be an approved member or certified organization to use them. If you don’t have permission to use these credentials, consider using different images or words to imply your products were never tested on animals.

5 – Do you have the correct contact information on the back panel?

The FDA regulations state you must include a way for your customers to contact you. The words: “manufactured for” or “distributed by” (Your Brand Name) You must also provide your contact details, including full company name, city, state, and website. If you do not have a website, you must provide the full street address and phone number so consumers may contact you if issues arise.