Cosmetic Labeling: Your Straightforward Guide
If your boutique cosmetics line is ready to become a mass market product, it’s time to make sure you’re familiar with cosmetic labeling requirements. Once you start producing more than a handful of lotions, soaps or other products, you need to comply with Food And Drug Administration (FDA) labeling regulations.
FDA requirements are intended to mitigate confusion about products, helping consumers know more than just the cosmetic product name and avoid potential hazards and allergic reactions. Here’s what you need to know to ensure your cosmetics labeling meets FDA obligations.
Is the Product a Cosmetic or a Drug?
The first step is understanding how your individual products are classified. If something is designed to treat or prevent a disease, it’s classified as a drug. (This includes personal care products such as sunscreens, antibacterial soap and hand sanitizer.) While they’re also cosmetics products, the information panel must follow pharmaceutical labeling regulations, not FDA cosmetic regulations.
What Are the Components of FDA Compliant Cosmetic Labels?
An FDA compliant cosmetic label has two main parts – the principal display panel and the information display panel.
The principal display panel (PDP) is the label on the front of the container. It must cover one side of a rectangular container, or 40% of a cylindrical container and is the part of the label that faces outward on the shelf, displaying your product and brand name.
The information display panel is placed to the right of the principal display panel for cosmetic labeling. Both panels can be printed on a cylindrical or corner wrap label. If there isn’t enough space directly to the right of the principal display panel, the information display label can go on the back. For example, if you have a rectangular bottle with narrow sides, the principal display panel goes on the front and the information display panel goes on the back.
Required Information on the FDA’s Principal Display Panel
The principal display panel goes way more in depth than simply adding on the product name. In addition to the descriptive name (or brand name) of the product, you also need a statement of identity and the net contents.
- Brand Name: An ingredient name cannot be used in the brand name of a product.
- Statement of Identity: Unless it’s obvious what the product is, the plain English term for the product must be printed on the front of the package. For example, a soap bar, a lotion bar and a shampoo bar look identical. To avoid confusion, a generic term like “lotion bar” or “bar soap” must be printed on the front product label. If the cosmetic product is packaged in two containers, such as a bottle inside a box, only the inner container needs an identity statement.
- Net Contents: Liquid contents can be listed by volume for cosmetic products, while solid and semi-solid products must list their net weight. Generally speaking, a semi-solid is any substance that isn’t solid, but isn’t liquid enough to be poured or pumped. The weight must be listed on the bottom 30% of the panel and use a font that is at least 1/8 inch high. If the PDP is less than 5 square inches in size, the size and placement requirements for weight and volume are waived.
The contents statement must be the same or lower than the weight or volume of product that actually reaches the consumer. The measurement must take into account fluctuations in manufacturing as well as evaporation during storage.
Required Information on the FDA’s Information Display Panel
The following information is imperative when complying with ingredient labeling guidelines for a cosmetic label’s information display panel:
Drug Ingredient Declaration: The ingredient list must appear in descending order (highest content to lowest) until you get to ingredients that make up less than 1% of the product. (These trace ingredients can be listed in any order.) If you use a blended ingredient in your cosmetic product, the components must be listed as separate ingredients. For example, if you use a fragrance that contains alcohol, you must list the fragrance ingredients and alcohol separately.
Ingredients must use the International Nomenclature Cosmetic Ingredient (INCI) name, except for botanicals. These should be listed by their English names, not the Latin names used by the INCI, but the Latin name can be added in parenthesis next to the English name. If a cosmetic ingredient isn’t listed in the INCI, you can choose a name used in these dictionaries:
- United States Pharmacopeia (USP) dictionary
- National Formulary
- Food Chemical Codex
- United States Adopted Names (USAN) council nomenclature
This cosmetic label information must be in a font that is at least 1/16 inches in height on labels over 12 square inches. On labels smaller than 5 square inches, it must be at least 1/32 inches in height.
Warning Statements for Cosmetic Labeling
Warnings or caution statements are required for some cosmetic labeling to comply with Code of Federal Regulations Title 21 part 701. Here are some common examples.
Bath Products Including Bath Bombs and Bubble Bath
An adult product should be labeled “Keep Out of Reach of Children,” while a product intended for children should be labeled “Keep Out of Reach of Children Except Under Adult Supervision.”
Tanning Products Without Sunscreen
Tanning products that do not provide protection from UV and UVA rays must explicitly disclose that fact in order to not be misbranded:
“Warning – This product does not contain a sunscreen and does not protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risk of skin aging, skin cancer, and other harmful effects to the skin even if you do not burn.”
Feminine Deodorant Sprays
Feminine products, such as deodorant sprays, must include safe use instructions:
“Caution – For external use only. Spray at least 8 inches from skin. Do not apply to broken, irritated, or itching skin. Persistent, unusual odor or discharge may indicate conditions for which a physician should be consulted. Discontinue use immediately if rash, irritation, or discomfort develops.”
There is a standard warning for aerosol cosmetic products held under pressure:
“Warning – Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F. Keep out of reach of children.”
The warning “Avoid spraying in eyes” can be left off if the product doesn’t dispense as a spray, such as shaving cream. Replace the word “puncture” with “break” if the product is in a glass container.
A second warning about aerosol use must be included if the product is more than 10% propellant, and the container is over ½ ounce: “Warning — Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.”
Other Cosmetic Labeling Requirements
If the product contains a cosmetic ingredient that doesn’t have adequate substantiation of safety, the cosmetic label must include the warning:
“Warning: The safety of this product has not been determined.”
Name and Location of Business: This information can be the manufacturer, packager or distributor. If your company didn’t manufacture the product, the label must say “Manufactured by” or “Distributed by” before the company name. This must be the physical location, not a post office box.
How Do I Ensure I’m Using Compliant Cosmetic Labels On My Packaging?
Pressure sensitive labels are ideal for cosmetic labels. Labels can be made with materials that withstand high moisture conditions (like those found in bathrooms) and offer plenty of options for paper stock and printing to help your label design stand out.
Starting out small? Our Tabletop Wrap Labeler is perfect for small batches of round containers. Just drop the vials or bottles into the magazine, and the machine applies the labels automatically.
Need to put cosmetic labels on specific products like tall shampoos, toothpastes, lotions or other bottles for personal care items? CTM Labeling Systems has numerous options for custom bottle labeling, and we pride ourselves in designing built-for-purpose solutions for any labeling application.
Get the Consistency You Want for Your Cosmetic Labels
If you’re looking for new solutions for cosmetic labeling, contact CTM Labeling Systems. Our local distributors can work with you to design a labeling system that fits your cosmetic product’s production system and delivers the look you want while still meeting regulatory guidelines.