Example of lip balm labeling requirements.

Everything You Need to Know About Lip Balm Labeling Requirements

Introducing a new lip balm label should be a straightforward process. It’s an established product with standard recipes, packaging, and market categories. You can even purchase a vial labeler that labels small tubes with minimal setup. However, label regulations are confusing. It might require specific phrasing to be legal, including a combination of drug and cosmetics labeling information. Working with regulations on the confined space of a lip balm tube can give you a major headache. How do you pull these elements together to make a compliant yet attractive label? Before you begin, understand the lip balm labeling requirements.

Is Your Lip Balm a Cosmetic, a Drug, or Both?

Labeling on products is dictated by the Federal Food Drug and Cosmetic Act (FD&C Act.) and the Fair Packaging and Labeling Act (FP&L Act.). These define cosmetic products as anything used for beauty that does not alter the human body‘s structure or functions. If it affects the body’s structure or functions, it’s considered a drug.

Some personal care products qualify as both cosmetics and drugs under FDA regulations. For example, sunscreen lotion protects the skin from UV light but also functions as a skin cream. Toothpaste is a cosmetic, but toothpaste with fluoride is both a cosmetic and a drug. Meanwhile, soaps can fall under either category or their own “soap” category. Since categorizing can get confusing, the FDA website (Food and Drug Administration) has a page to help manufacturers determine how their products are categorized.

Standard lip balm is a cosmetic. However, if you have ingredients that actively heal and protect lips (or use ingredients that act as sunscreen), it’s both a drug and a cosmetic.  

Labeling to Meet Cosmetic Regulations

Unless contradicted by drug requirements, all lip balms must follow FDA labeling regulations for cosmetics.

The Principal Display Panel (PDP) on the front of your packaging must have a statement of identity and quantity. On a round container, the PDP must cover 40% of the height multiplied by the circumference. On a rectangular container, it must cover one side.

The statement of identity is both the product name and its common name. You can use ingredients in the common name of the product, but you must use all the ingredients that make it unique. For example, you could call a lip balm with peppermint and shea butter “lip balm” or “lip balm with shea butter and peppermint.” But, you can’t legally call it “peppermint lip balm.”

Lip balm is a solid, so the net contents of the container should be listed by net weight. This includes both customary and metric measurements. The typeface should be 1/16 inches in height for product labels less than 5 square inches. For reference, a standard lip balm label covers about four square inches.

Ingredient Labeling

One panel on the container must include a list of ingredients. Most ingredients used in the balm must be listed in order of weight from most to least. Colorants are always last on the list, no matter how much is used. Ingredients need to use standard names from the International Nomenclature of Cosmetic Ingredients. The typeface must be at least 1/32 inches in height for small labels and 1/16 inches for labels larger than 12 square inches.

The information panel on the back of the outer container must include directions for safe use, warning statements, manufacturer information (i.e. company name), contents, and any other required information. The warning typeface must be at least 1/16 inches in height. Every other typeface should be “reasonably related to panel size.” Measurements are based on the height of a lowercase “o.” You can find more information on typeface requirements in these FTC regulations: 21 CFR 701.2(a) (b), 701.3(b), 701.11(c), 701.13(i) and 740.2(b). 

The manufacturer information includes the name of the manufacturer and contact information formatted to meet FTC regulation 16 CFR 500.5(c). However, federal regulations also specify that the address can be omitted if “it is listed in a readily accessible, widely published, and publicly available resource.” There’s no clear definition for this, but you should be safe if you list your website on the packaging and you have the street address on the site. It must be the physical location of the business, not a post office box.

If you package tubes of lip balm in boxes or on cards, you have both inner and outer containers. Only the outer container can have a principal display panel. The inner container’s front panel only needs to list the name of the product. The information panel on this container must include directions for safe use, warnings, manufacturer information, and weight.

Labeling to Meet Drug Regulations

Cosmetics that qualify as a drug need a drug facts panel. This changes the format of the ingredient list and adds more information on use and safety. If you want to learn more about Drug Facts labels, read our blog “Pharmaceutical Labeling: Understanding Requirements & Guidelines.”

Additional Information Required

Active Ingredients

    • Includes the drugs in the balm, as well as their amounts.

Intended Uses

    • The intended effects of the drugs. For example, “temporarily protects and helps relieve chapped or cracked lips.”

Warnings

    • Requirements vary depending on how your balm is used. Commonly, all balms should have “For external use only” in this area. If your lip balm contains sunscreen, it needs a warning about sun exposure.

Directions

    • Instructions on using the product.

Other Information

    • Anything else the user should know about, such as storage and disclaimers.

Inactive Ingredients

    • This is everything not listed in the “Active Ingredients” section. All non-drug ingredients are listed from heaviest to lightest, including essential oils and perfumes, color additives, and dyes.

This information must be on the outer packaging. However, regulations aren’t clear on the inner packaging. There is a “temporary” exception to the Drug Facts Rule that allows convenience size packaging to be exempt from this labeling requirement. 20 years after this went into effect, the FDA still hasn’t established a rule about the conditions in which a label can be exempt. Today, “convenience size” is defined as a container with no more than two adult doses that would require more than 60% of the available space covered with a Drug Facts label. 

However, the standard is to leave the Drug Facts label off of small inner containers of pharmaceutical cosmetics, no matter the dose. Most medicated lip balms come on a hanging carton or blister card. The back of this card has the drug facts panel, while tube labels only list the product name, weight, and directions.  

Get the Equipment You Need to Label Any Size Container

If you’re looking for a better way of labeling cosmetics and lip balm, contact CTM Labeling Systems. We have local distributors that will work with you to create a labeling system that fits your production needs, including speed, accuracy, and appearance. Now that you know the ins and outs of lip balm labeling requirements, get started with your automatic machine.