Your Guide to Cosmetic Labeling

Your Guide to Cosmetic Labeling

BY: JENNA WAGNER / DATE: 05/05/2022 / TOPICS: HANDEL DETALICZNY, REGULATORY COMPLIANCE

The cosmetic industry faces strict labeling requirements to protect consumer safety and promote transparency. While the cosmetic space and the labeling regulations associated with it aren’t new, it’s a growing market. According to a 2022 report by Industry Research, the global Cosmetic Skin Care market was valued at $55 billion in 2020 and is expected to reach $89 billion million by the end of 2027, growing at a CAGR of 7.1% during 2021-2027. 

In this blog, learn what qualifies as a cosmetic, the requirements for a cosmetic product label, and how to choose the best cosmetic labeling software.

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What is considered a cosmetic? 

The first step in labeling cosmetic products is answering the following question: is my product considered a cosmetic or a drug? 

Defining a cosmetic 

The US Federal Food, Drug, and Cosmetic Act (FD&C) defines cosmetics as “articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions.” This includes lotions, perfumes, shampoos, lipsticks, eye makeup, fingernail polish and more.  

Defining a drug 

On the other hand, the FD&C defines drugs as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body.”  

Products that are both cosmetics and drugs 

While there are two clearly separate definitions for drugs and cosmetics, they are not mutually exclusive; some products can be considered both a cosmetic and a drug. The difference comes down to the intent of the product: Is the product intended to cleanse or promote attractiveness, or does the product affect the structure or function of the body? For example, deodorant masks odor, but when antiperspirant is included, the function of the product alters your body by restraining sweat, classifying the product as both a cosmetic and drug. Shampoo cleans your hair, but anti-dandruff shampoo is also considered a drug because of the intended use of treating dandruff.  

Classifying your product as a cosmetic, drug, or both is essential because it determines what is required on your label.  

• Cosmetics must follow the Food and Drug Administration’s (FDA) Code of Federal Regulations (CFR) Title 21, parts 700 to 740 (21 CFR 700 to 740).  
• Drugs must follow the FDA’s 21 CFR 210 and 211 which includes more extensive requirements.  

If your product is considered both a cosmetic and a drug, the product label must adhere to both sets of regulations.  

To learn more about what is considered a cosmetic vs. a drug, see the FDA’s article, “Is It a Cosmetic, a Drug, or Both?”

What is required on a cosmetic label? 

There are three main categories of requirements on cosmetic product labels: the Principal Display Panel, the Information Display Panel, and other requirements related to formatting and use of language.  

1. Principal Display Panel (PDP) 

The PDP is the portion of the label that is most visible, and the part of the product that is facing outwards on a retail shelf (21 CFR 701.10). The PDP must include the following: 

• Product Identity: Identifies what the product is. Consumers need to be able to differentiate between shampoo, conditioner, body wash, facial cleanser, body lotion, etc. 
• Net Contents: Volume of liquids or net weight of solids. 

2. Information Display Panel (IDP) 

• Business Name and Location: The city, state, and zip code of the company. If the company who is distributing the product is not the manufacturer or packer, the label must state “manufactured by” or “distributed by.” 
• Ingredients: Ingredients listed in descending order of predominance. Cosmetics that are used in professional settings and not sold to consumers are exempt from listing ingredients. 
• Warning Statements: Warning statements for products are required when the cosmetic may be hazardous to consumers when misused. Examples of warning statements include:
  • Cosmetics with unsubstantiated safety: Warning – the safety of this product has not been determined. (21 CFR 740.10)
  • Cosmetic aerosols: 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. (21 CFR 740.11 (a))
  • Foaming detergent bath products: Caution – use only as directed. Excessive use of prolonged exposure may cause irritation to skin and urinary tract. Discontinue use if rash, redness, or itching occurs. Consult your physician if irritation persists. Keep out of reach of children. (21 CFR 740.17) 

3. Other Cosmetic Labeling Requirements

• No Misbranded Statements: According to the FD&C Act, a cosmetic is misbranded if labeling is false or misleading, label does not contain the necessary requirements, the required information is not displayed prominently or is conspicuous, or the container is misleading (Sec. 301, FD&C Act).
• Prominence and Conspicuousness: The required information on a cosmetic product label must be displayed in a visible and clear manner. The FDA’s cosmetic labeling guide has specific requirements for label size and font size (21 CFR 740.10). 
• While directions outlying how to use the product and other symbols are not required by the FDA, they are highly recommended. 

To see the full requirements of cosmetic labeling, see the FDA’s Cosmetic Labeling Guide.  

What to consider when choosing cosmetic labeling software

Make your cosmetic products stand out while staying compliant

When it comes to marketing and selling your cosmetics, having eye-catching product labels and packaging is crucial. But while your products need to stand out, they also are required to contain all the necessary information to stay compliant. You will need to choose cosmetic labeling software that can accommodate both the creative aspect of your cosmetic label by allowing high-res artwork, and the compliant aspect by allowing warning symbols, statements, and ingredient lists.  

Easily create multiple labels for different cosmetic product variations 

Typically, cosmetic products come in various sizes, shades, or scents. This means one cosmetic product, such as a lip balm, might need to have identical labels apart from having different scents. Instead of creating 10 separate labels to change the scent name, your cosmetic labeling software should give you the ability to design label templates where you only need one label template with variable fields. 

Keep your cosmetic labels secure 

Since cosmetics labels have mandated requirements by the FDA, it’s critical that your cosmetic labeling software keeps your labels protected from unwanted changes. If someone who isn’t familiar with cosmetic labeling requirements decreases text size, deletes a warning statement, or moves an element on the label, this could qualify your product as mislabeled or misbranded. 

The best cosmetic labeling software 

Label design software 

When you need to design cosmetic product labels that are compliant and stand out, CODESOFT is the best label design software to meet your needs. CODESOFT supports all common file formats, including .jpg, .png, .gif, .eps, .tif, .bmp, .pdf, which gives you the ability to import any artwork. Either import your artwork as a background image that is static to your label templates or import your artwork as variable images that automatically populate with each product type or variety. Learn more about how to make your product labels stand out in our blog.   

Smart label templates in CODESOFT enable you to minimize the number of label files and increase efficiency and speed in your labeling process. Instead of having countless separate label files for each product variety, scent, or shade, simply create one label template that pulls in variable information from a database or spreadsheet. To learn more about creating database connections in CODESOFT, watch our webinar Creating Database Connections with TEKLYNX Software. 

Learn more about CODESOFT or download a free 30-day trial. 

Label security and traceability software 

To keep your labels protected from unwanted changes, LABEL ARCHIVE is the best cosmetic labeling software for security. LABEL ARCHIVE integrates with CODEOSFT and gives you the ability to set up a custom label approval process, ensuring all cosmetic product labels are approved and compliant before sending to print. Through user permissions, ensure only authorized users can edit or print labels, so labels don’t become non-compliant through an unintended edit. If a labeling mistake is made such as printing the wrong label or changing a label template, LABEL ARCHIVE offers a full traceability audit and version history to pinpoint the exact date, time, location, and user to give a diagnosis of the error.  

Learn more about LABEL ARCHIVE or request a demo.

If you want to learn more about our cosmetic labeling software or how to make your cosmetic product labels compliant, talk to one of our labeling experts. 

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