Breaking Down FDA Guidelines for Cosmetic Labeling
Packaging is Important
Whether you’re going with a private labeling formula or a custom formula, manufacturing is one of the last steps- you’re almost finished! Now that the formula has gone through cosmetic testing, it’s time to focus on your packaging. The packaging is critical because it’s the consumer’s first impression of your product and your brand.
Additionally, everything in the cosmetics business has to be approved by FDA guidelines. You saw that with testing, and you’ll see it again with packaging. The actual FDA guidelines page is long, and a bit redundant, so here is a basic overview and a guide to making sure you package right.
Vernacular Check: FDA Vocabulary
First, let’s start with some definitions directly from the FDA guidelines page.
Cosmetic: a product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. Can a cosmetic also be a drug? Yes! If it aligns itself with the first definition and also aims to “treat or prevent disease or otherwise affect the structure or any function of the human body.”
Package: a container or wrapping, other than a shipping container or wrapping, in which a consumer commodity is delivered or displayed to retail purchasers.
Label: a written, printed, or graphic display of information on the container of a cosmetic.
Principal Display Panel (PDP): the part of a label that the consumer sees or examines when displayed for retail sale. See “Other Terms to Know” below for more information.
It may seem a little silly to go over these definitions. Still, your cosmetic products must have the proper branding: Improper packaging or labeling = Violation of FDA guidelines = Bad for business.
Examples of FDA Violations
So what are some ways you can come into violation of FDA guidelines? Obviously, if your label is untruthful or misleading, this is a violation. But there are some subtle ways that you may not know.
The label doesn’t state
The name and address of the manufacturer, packer, or distributor
The net quantity of contents
The required information is not stated prominently, with conspicuousness, and in terms that it is read and understood by consumers under customary conditions of purchase and use.
The container or its fill is misleading.
Labeling 101
Now it’s time for us to get to the labels: sizing, placement, prominence and conspicuousness. Some of this information may seem elementary, but it’s important to go over! To the right, is a more visual version of this information. You can download the graphic below!
Placement of Info on Labels
You wouldn’t think it, but where you put the label is vital! It also differs between an outer container and an inner container.
For an outer container, the label and the PDP must appear on the outside.
On the front of your boxes (i.e., the PDP) must include:
Product Name
Identity (what it is)
Net Weight (must be within bottom 30% of PDP)
The backside/other side(s) of the box should include:
Quantity of Contents
Directions
Warnings
Name and Place of Business (business name + address of the manufacturer, and packer or distributor)
Ingredient Declaration
An inner container requires more information and is considered inner if packaged and displayed in a non-transparent box (i.e., folding carton). If the outer container is removed and put up for purchase, then the immediate container becomes the outer container and requires all the information above.
On the front panel, it must include:
Name of product
Identity (what it is)
On the back panels, include:
Directions
Warnings
Quantity of Contents
Name and Place of Business (business name + address of the manufacturer, and packer or distributor)
General Requirements for all Labeling
Turns out, there are laws and regulations surrounding things like the font size. Prominence refers to the placement of the label and the size, while conspicuousness refers to how easy it is to understand the label. You will refer here to all required information (i.e., warning statements, the quantity of contents, ingredients list, etc.)
Key things to keep in mind:
Panel display
The display that the consumer sees at the time of purchase must include the required information. It also means that the panel size must be large enough for the consumer to read.
2. Font size and style
The font’s size and style must be easy to read and meet the minimum requirements of height. There are different requirements for the information of the PDP, warning statements, and product name. More info on fonts later.
3. Background
The background must contrast from the label’s lettering for an easy read. For example, a white background for black lettering is high contrast, while pink lettering on a red background may be difficult for some people.
4. Nothing should block the required information.
This can include items like a graphic or design. The consumer needs to see the information so they can decide if they want to purchase it.
5. Language
All information for all required information must be in English. If a foreign language is represented (say, a K-beauty product), all required info must be in a foreign language.
Backside of the Box
The backside/other side(s) of the box should include:
Quantity of Contents
Directions
Warnings
Name and Place of Business (business name + address of the manufacturer, and packer or distributor)
Ingredient Declaration
Other Terms to Know
Quantity of Contents
This part is important because the consumer needs to know how much they’re getting! Quantity of contents is a fancy word for net weight. This statement should be located within the bottom 30% of the PDP of the outer container, and it’s usually parallel in line to the base on which the package rests.
It should also appear on the info panel of the inner container. It must be distinct and separated from other printed information and have a coloring compared to the background. Refer to the general requirements as needed.
Requirements:
Accuracy (this includes weight, volume, measurement, numerical count, etc.)
Consistency (fluid measure if liquid or weight if solid, semi-solid, etc.)
System (weight in pound and ounce; fluid in gallon, quart, pint)
Unit (must be same as weight statement)
Dual Declaration (if product is more than a pound, but less than four, must include total number of ounces in parentheses)
Principal Display Panel (PDP)
As mentioned above, PDP is the part of the label that the consumer sees or examines when displayed for retail sale. It must be large enough to contain all the required label information (location, size, multiple PDPs). The area of the PDP depends on the package.
Rectangular: fill one entire side
Cylinder: 40% of height x circumference
Other: 40% of total container surface (not top, bottom, neck, shoulder, or flanges)
Cosmetic Warning Statement
As always, you need to follow the general requirements for labeling to ensure prominence and conspicuous information. The font for the warning must be in bold.
Cosmetic Ingredient Labeling
These ingredients must be in descending order of predominance and also follow the general requirements for labeling. You should include all ingredients used unless it is a trade secret (and has its own complicated process).
Declaration of ingredients except for flavor, fragrance, and trade secret ingredients in descending order of predominance.
Prominence must be easy to read and understood.
Fonts 101
The font of all your labels matters, including directions, warnings, and even your product name. The FDA has a minimum for each label. Warnings and ingredients, for example, can not be smaller than 4.5 pt.
The minimum font size for the PDP area depends on its size in squared (sq) inches. If your PDP area or labeling space is:
Less than 12 sq inches, the minimum font size is 2.25 pt.
More than 12 sq inches, the minimum font size is 4.5 pt.
The quantity of contents (or net weight) also has font requirements. The bottom location requirement (on the outer container) is waived for PDPs of 5 sq inches or less.
If your PDP Area is:
less than 5 sq inches, the minimum font size is 4.5 pt.
More than 5 sq inches (but less than 25 sq inches), the minimum font size is 9 pt.
More than 25 sq inches (but less than 100 sq inches), the minimum font size is 13.5 pt.
More than 100 sq inches, the minimum font size is 18 pt.
Download our FDA Guidelines Breakdown for future use! It’s prettier to look at and less overwhelming
Congrats on finishing the article!
This FDA breakdown was long and it’s true. FDA guidelines aren’t going to be as fun as choosing lipgloss colors, but it’s important information nonetheless. I say you take a break from all the reading and order some samples!
