Why Cosmetic Labels Fail? The Hidden FDA Requirements That Lead to Seizures and Amazon Suspensions

You’ve spent months perfecting your formula. You’ve sourced the best ingredients. You’ve registered your facility under MoCRA. Your ingredient list is flawless, every component listed in descending order of predominance, using proper INCI names.

Then the FDA sends a warning letter. Or worse, your products get seized at the border. Or Amazon suspends your seller account. The reason? Your label is missing required contact information. Or your net weight isn’t bolded. Or your font size is too small. Or you’re making unproven claims.

Here’s the reality: most cosmetic companies obsess over their ingredient list and completely ignore the other labeling requirements that can get them into just as much trouble. 

The ingredient list is important, but it’s only one piece of the compliance puzzle.

1. Your Contact Information Is Non-Negotiable

This is the most frequently overlooked labeling requirement, and it’s one of the easiest ways to get your product flagged as misbranded. The FDA requires all cosmetic product labels to include contact information for the company that manufactured the product, the packer, or the business distributing it.

What you must include: Manufacturer, packer, or distributor name, street address, city, state, and ZIP code. If your business is listed in a current city directory or telephone book, you can omit the street address. If you’re not the manufacturer, you must include a qualifying phrase such as “Manufactured for…” or “Distributed by…”.

Why this matters: The FDA uses this information to track down the responsible party if there’s a safety issue. If your label doesn’t include complete contact information, your product is considered misbranded, and the FDA can seize it.

Real-world example: A small cosmetics brand launched on Amazon with beautiful packaging but forgot to include their street address. The FDA contacted Amazon, and the seller account was suspended. The cost of relabeling 5,000 units? $12,000.

Action Step: Review every product label and make sure your contact information is complete. It must be on the label.

2. Net Weight Requirements Are More Complicated Than You Think

You know you need to include the net weight on your label. But did you know there are specific rules about where it goes, how it’s formatted, and what font size you must use? Getting this wrong is one of the most common labeling mistakes.

Net weight must be: Printed in bold lettering, placed in the bottom third of the principal display panel (the front of your package), printed parallel to the bottom of the package, and stated in both imperial and metric units.

For solid, semisolid, or viscous cosmetics, net weight must be stated in avoirdupois pounds and ounces. For liquid cosmetics, net weight must be stated in U.S. gallons, quarts, pints, and fluid ounces.

If your product is one pound or one pint or more, you must express the net weight in ounces, followed in parentheses by the largest whole units (e.g., “16 oz (1 lb)”).

Why this matters: The net weight tells customers how much product they’re getting. If it’s not formatted correctly, your product is misbranded.

Action Step: Measure your net weight statement. Make sure it’s bold, in the bottom third of the front panel, and parallel to the base.

3. Font Size Can Make or Break Your Label

The FDA has specific font size requirements for the net weight statement. The minimum font size depends on the size of your principal display panel.

Size of Principal Display Panel	Minimum Font Size
5 square inches or less	1/16 inch
More than 5 but not more than 25 square inches	1/8 inch
More than 25 but not more than 100 square inches	3/16 inch
More than 100 square inches	1/4 inch

Why this matters: If your font size is too small, your product is misbranded. It’s that simple.

Action Step: Get out a ruler and measure your font size. Don’t guess.

4. Warning Statements Are Required for Certain Products

If your product contains certain ingredients or is intended for a specific use, you may be required to include a warning statement.

For example:

• Aerosol products: Must have a warning about flammability and avoiding spraying in eyes.

• Feminine deodorant sprays: Must have a warning about not applying to irritated skin and discontinuing use if a rash develops.

• Tanning products without sunscreen: Must have a warning that the product does not protect against sunburn.

Why this matters: Failing to include a required warning statement is a major violation and can lead to product seizures and recalls.

Action Step: Review the FDA’s list of required warning statements and make sure your labels are compliant.

5. Product Name Mistakes Can Get You Flagged as Misbranded

Your product name can’t be misleading. You can’t call your product “Wrinkle Eraser” if it doesn’t actually erase wrinkles. You can’t call it “Botox in a Bottle” if it doesn’t contain botulinum toxin.

You can’t even use the word “soap” unless your product is true soap (made from fats and an alkali). If your product is a synthetic detergent, you have to call it something else, like “cleansing bar” or “body wash.”

Why this matters: Misleading product names are a fast track to an FDA warning letter.

Action Step: Review your product names and make sure they’re not making any implied claims that you can’t support.

6. Claims Must Be Proven—Or You’re Violating the Law

Any claim you make on your label must be substantiated. If you say your product is “clinically proven,” you need to have a clinical study to back it up. If you say it’s “dermatologist tested,” you need to have a dermatologist who actually tested it.

If you say it’s “hypoallergenic,” you need to have data showing it causes fewer allergic reactions than other products.

Why this matters: Unproven claims are a violation of both FDA regulations and the Federal Trade Commission (FTC) Act. The FTC can fine you for every violation.

Action Step: Go through every claim on your label and ask yourself: “Can I prove this?” If the answer is no, remove the claim.

7. Imported Products Must State Country of Origin

If your product is manufactured outside the United States, you must state the country of origin on the label. The statement must be conspicuous and in English.

Why this matters: This is a requirement of the Tariff Act of 1930. Failing to include the country of origin can result in your products being seized at the border.

Action Step: If your products are imported, make sure the country of origin is clearly stated on the label.

The Bottom Line: Labeling Is More Than Just Ingredients

Cosmetic labeling compliance is a minefield of technical requirements. The ingredient list is just the beginning.

You have to get the contact information right, the net weight right, the font size right, the warnings right, the product name right, the claims right, and the country of origin right.

One mistake can lead to a warning letter, a product seizure, an Amazon suspension, or a lawsuit.

Don’t leave your labeling to chance. Have an experienced cosmetics attorney review your labels before you go to market. It’s the best investment you can make in your business.

The Bustos Law Group specializes in cosmetics labeling and FDA compliance. We’ve helped hundreds of brands navigate the complexities of labeling regulations and avoid costly mistakes. Contact us today for a label review.