FDA LABELING 101
You can’t make a cosmetics business without dealing with the FDA. To save your time (and money), here’s an easy explanation of all you need to know about FDA labeling.
Please use this as an educational guide only, not as legal advice (we’re not lawyers!). Always consult a lawyer for final questions, and keep in mind that the updated FDA guidelines can be found on the FDA site (here!) at any time.
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, the immediate container becomes the outer container and requires all the information above
FRONT
Name of product
Identity (what it is)
NOTE:
Font Size: The bottom location requirement (on the outer container) is waived for PDPs of 5 sq inches or less, but everything else follows. 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.
BACK
Directions
Warnings
Quantity of Contents
Name and Place of Business (business name + address of the manufacturer, and packer or distributor)
OUTER 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, the immediate container becomes the outer container and requires all the information above
FRONT
Product Name
Identity (what it is)
Net Weight (must be within bottom 30% of PDP)
QUANTITY OF CONTENT
Quantity of contents is a fancy word for net weight. This statement should be placed 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)
BACK
Directions
Warnings
Quantity of Contents
Name and Place of Business (business name + address of the manufacturer, and packer or distributor)
GENERAL REQUIREMENTS
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.
FONT SIZE & 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.
Background
The background must contrast from the label’s lettering for an easy read. For example, white background for black lettering is high contrast, while pink lettering on a red background may be difficult for some people.
Nothing should block the required information.
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.
FDA VOCABULARY
Cosmetic: a product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.
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)
PDP is the part of a 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)
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.
QUICK MATH HELP
What does math have to do with FDA labeling? It helps you convert inches to millimeters, figure out the size requirement for the PDP of your container, find the minimum font size, and much more!
Let’s start easy. How do you convert inches to millimeters (and vice versa)? Use Google. Type in “google calculator in to mm” or “google calculator mm to in,” and the first result will be a convertor! It’ll give you fast and accurate results.
Cubic Box
Find the width and the height. The width and depth are the same.
Follow this formula: 6wh.
Rectangle Box
Find the depth (or length), width, and height.
Follow this formula: 2(wh + dh + dw)
Cylindrical Box
Find the depth, height, and radius. Remember the number for pi.
Follow this formula: πdh + 2(πr2).