Don't Get Misbranded: A Business Owner's Guide to FDA Skincare Labeling
When you’re in the business of creating a skincare brand, the excitement of formulation and branding can make the legal side feel like an afterthought. It's not. Getting your labeling wrong can lead to costly fines, product recalls, and a complete loss of consumer trust.
As a business owner, you are legally responsible for ensuring your product labels comply with FDA regulations. Here’s a breakdown of the key requirements you need to know.
The Four Core Labeling Requirements
According to the Federal Food, Drug, and Cosmetic Act (FD&C Act), your cosmetic label must include four primary pieces of information.
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Identity Statement: This is the most basic requirement: What is your product? Is it a "Body Lotion," a "Facial Serum," or a "Hand Cream"? This statement must be prominent on the Principal Display Panel (PDP), which is the front of your product packaging.
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Net Contents: How much product is in the container? This must be stated in both U.S. Customary (e.g., fluid ounces, ounces) and metric units (e.g., mL, grams). The net contents statement must be placed on the bottom 30% of the PDP.
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Name and Place of Business: The label must clearly state the name and address of the manufacturer, packer, or distributor. If you’re not the manufacturer, you must include a phrase like "Distributed by" or "Manufactured for."
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Ingredient Declaration: This is where many new businesses make mistakes. All ingredients must be listed in descending order of predominance. This means the ingredient with the highest concentration is listed first, and so on.
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INCI Names: You must use the established International Nomenclature of Cosmetic Ingredients (INCI) names for each ingredient.
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"Fragrance" or "Flavor": You can use these terms to protect a trade secret, but it's important to be aware of any local regulations that may require more transparency.
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Color Additives: These can be listed at the end of the ingredient list, regardless of their concentration.
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Claims to Avoid and a Crucial Distinction
One of the most important aspects of FDA compliance is the distinction between a cosmetic and a drug.
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Cosmetic: Intended to cleanse, beautify, promote attractiveness, or alter the appearance.
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Drug: Intended to diagnose, cure, mitigate, treat, or prevent disease, or affect the structure or function of the body.
If your product makes a "drug claim" (e.g., "treats acne," "reduces wrinkles," "heals eczema"), it will be regulated as a drug and must comply with those more stringent regulations. This includes the need for FDA pre-market approval. A common example is sunscreen, which is considered a drug because it protects against UV radiation.
Final Tip: Work with an Expert
While this guide provides a solid overview, the best way to ensure compliance is to partner with a reputable manufacturer who has a deep understanding of FDA requirements. They can provide guidance on labeling, safety testing, and ingredient sourcing, allowing you to focus on building your brand with confidence.
Scientific and Regulatory References:
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U.S. Food & Drug Administration (FDA). (n.d.). Cosmetics Labeling Guide. Retrieved from https://www.fda.gov/cosmetics/cosmetics-labeling-regulations/cosmetics-labeling-guide
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U.S. Food & Drug Administration (FDA). (n.d.). FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated. Retrieved from https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated
Article by: Dahlia Kelada MSHS-INTM, SALVE Founder/CEO, Integrative Medicine Educator, Cosmetic Formulator