Your FDA Checklist for Personal Care and Beauty Product Packaging Requirements

All personal care and beauty products manufactured in the US or imported are monitored and regulated by the FDA. The FDA’s Fair Packaging and Labeling (FP&L) Act protects consumers from unsafe and deceptively packaged or labeled products by outlawing interstate commerce of adulterated or misbranded cosmetics. Producers of personal care and beauty products, including soap and aromatherapy products, must comply with all the regulations and labeling requirements provided by the FDA. 

This blog focuses on the cosmetic product packaging checklist to guarantee your product is FDA-compliant.

Before we look at the packaging checklist, let’s define common terms used in beauty product labeling and packaging:

  • Package: A package refers to the container or wrapper you use to display or deliver the product to retailers. The package includes covers of lotion and creams.
  • Label: The label is the printed or graphic material that appears directly on the product or its attachments.
  • The Principal Display Panel (PDP): PDP refers to the part of the package that the consumer will most likely read or see first. PDP refers specifically to the front panel of the label on the outer package.
  • The Information Panel (IP): IP comprises a label’s back and side panels.

7 Crucial Rules to Comply With the FDA

FDA Checklist: Skin and hair care beauty product mock-up

The FDA provides a comprehensive labeling guide comprising label placement, label content, type size, and ingredient list. Failure to comply with these rules will result in setbacks and lead to the FDA labeling your product “misbranded.” The following are some of the crucial things to keep in mind when creating a packaging checklist for a cosmetic product:

Display labeling information on the outer container and inner container

The FDA requires that critical labeling information be displayed clearly on the outer and inner packaging containers. 

Outer container requirements: The package that houses the container holding the product is called the outer container. These include packaging materials such as boxes, wrapping papers, cartons, and more. The information to be displayed on the outer container includes:

  • Principal Display Panel (PDP) – display the following information on PDP: name of the product, identity, warning, and net quantity of ingredients.
  • Information Panel (IP) – display the following information on IP: directions for safe use, warning, name, and place of business, ingredient declaration, and additional information.

Inner container requirements: Inner container refers to anything holding the actual product, such as jars and bottles. If you are not displaying your product with an outer container, the inner container becomes the outer container. The information to be displayed on the inner container includes:

  • Front Panel – display the name of the product on the front label.
  • Information Panel (IP) – display the following information on IP: directions for safe use, warning, name, and place of business, ingredient declaration, and additional information.

Declare the correct ingredient deck on the packaging

All your ingredients must be listed in full and in the correct order. The FDA regulation 21 CFR 701.3 requires the declaration of all ingredients except for trade secret ingredients such as flavor and fragrance. 

The product ingredients must be listed in descending order of prominence. In a nutshell, list your ingredients from the highest percentage to the lowest percentage. The following are some of the other things to keep in mind when making ingredient declarations:

  • Prominence: Ensure the declaration is prominent and conspicuous to be read and understood easily by consumers.
  • Type size: The font size should not be less than 1/16 inch in height. It should not be less than 1/32 inch in height if the total surface area available for labeling is not more than 12 square inches. 

Provide the correct net quantity of contents

You should avoid overstating the amount of product in a package. This is because your fill weight rarely matches the size of your bottle. For example, a 2 oz jar will not necessarily translate to 2 net ounces of powder. 

The rule of thumb is to give a slightly lower number to enable you to be at a lower part of the margin of errors. Other rules to remember regarding the number of contents include:

  • The term “net contents” and “net” is not mandatory for fluids but required for weight. “Net” is typically used with solid rather than liquid products. 
  • The term “fluid” or (“fl”) is required to differentiate liquid ounces.

Follow guidelines when making claims on your product

If you are making any claims, you must comply with FDA guidelines regarding claims. The following are some of the tenets of the guidelines:

  • Cosmetic: A cosmetic is any product designed to be applied to the human body for cleansing, beautifying, enhancing attractiveness, or altering the appearance.
  • A cosmetic drug: Typically, a product can be both a cosmetic and a drug. If cosmetic claims to accomplish the above deeds by changing the skin’s structure or through physiological processes, it is also a drug. Such a product must follow a drug’s FDA packaging and labeling guidelines.

Provide correct contact information on the back panel

The FDA requires that you incorporate a clear way for the consumers to contact you. The following are a few tips to satisfy this requirement:

  • Use the words “manufactured for” or “distributed by” (Brand Name).
  • Provide your contact details such as the company name, city, state, and website. If you don’t have a website, ensure you list the full street address and company phone number.

Meet language requirements

Unless your products are distributed in regions where English is not prominent, such as Puerto Rico, your labels must appear in English. If your label has foreign language representations, provide a similar printed matter in English.

Include the 5 Elements of a Compliant Label

The company's product quality certificate is compliant

The following are the five elements of a compliant label:

  1. Statement of identity: The statement of identity is comprised of the product name and the name of the cosmetic. For example, your product is Glow body lotion, Glow is your product name, and body lotion is the nature of the cosmetic.
  2. Name and place of business: Provide the details of the manufacturer, packer, or distributor and their addresses (street address, name of the city and state, and zip code). If the manufacturer’s address is missing from the label, ensure you add “manufactured by” or “distributed by” before your address.
  3. Net quantity of contents declaration: Net quantity of contents refers to the product’s total weight. It must be expressed correctly using the Imperial System of Measurement. Express weight statement with terms “net weight” or “net wt.” and fluid measurements with terms “net contents” or “net” before the fluid measurements.
  4. Warning statements: Where appropriate, your labels should carry warning statements. The statements inform consumers of any potential health hazards that are likely to arise from using the product. e.g., Warning: Avoid spraying in the eyes.
  5. Labeling claims: FDA doesn’t provide a list of approved or acceptable claims for cosmetics. However, ensure any labeling claim you make is truthful and not misleading regarding the potency of a cosmetic or drug.

Contact AWT Labels and Packaging for FDA-compliant Solutions

The FP&L prohibits the sale, distribution, or promotion of adulterated or misbranded cosmetics. It is prudent to ensure your product is safe for the consumer when used, following the directions on your label. The checklist we provided above includes helpful information and safety elements that the FDA requires for labels and packaging “personal care and beauty” products.

If you have further questions, AWT specializes in unique, innovative, and sustainable label and packaging solutions for the healthcare, industrial, food and beverage, personal care and beauty, household care, and specialty markets. We are the leading labeling provider offering innovative labeling solutions. Label Us Experts. Reach out to AWT today!

Written By:

Posted On:

Written By:


Posted On:

Updated On: