Navigating FDA Regulations for Skincare Products: What Brands Need to Know

Launching a skincare product in the U.S. requires more than just a great formula — it means complying with FDA regulations. For clean beauty brands, it’s especially important to align with transparency and ingredient standards while avoiding misleading claims. Here’s a clear, practical guide to help your product development team stay compliant.

1. Is Your Skincare Product a Cosmetic or a Drug?

The FDA classifies products as either cosmetics or drugs based on their intended use:

• Cosmetics – Products that cleanse, beautify, or improve appearance without affecting the body’s structure or function.

• Example: Moisturizer for hydration = cosmetic.

• Drugs – Products that treat, prevent, or cure a condition or alter body function.

• Example: Moisturizer that “treats eczema” = drug.

👉 Clean Beauty Tip: Avoid medical terms like “heal” or “repair” unless you plan to seek FDA drug approval.

2. Labeling Requirements

The FDA has strict rules for ingredient lists and product claims:

✅ Ingredients must be listed in order of concentration using INCI names.

✅ Fragrances must be disclosed unless they’re trade secrets.

✅ “Hypoallergenic” or “dermatologist-tested” claims require supporting evidence.

👉 Clean Beauty Tip: Phrases like “non-toxic” and “chemical-free” are not regulated — make sure they are accurate and not misleading.

3. Prohibited and Restricted Ingredients

The FDA bans only a few ingredients in cosmetics, including:

• Mercury compounds

• Chlorofluorocarbons

• Certain color additives

Clean beauty brands often go further by avoiding:

• Parabens

• Phthalates

• Sulfates

• Synthetic fragrances

👉 Example: Parabens are legal under FDA rules, but many clean beauty brands avoid them to meet consumer expectations.

4. Marketing Claims and Compliance

The FDA regulates what you can say about product benefits:

✅ Allowed Claims: “Hydrates skin,” “Softens texture”

🚫 Drug-Level Claims: “Treats acne,” “Stimulates collagen”

👉 Clean Beauty Tip: Instead of saying “prevents acne,” say “helps reduce excess oil.”

5. Manufacturing Standards (GMP)

While the FDA doesn’t require pre-market approval for cosmetics, manufacturers must follow Good Manufacturing Practices (GMP):

✅ Clean, well-maintained production facilities

✅ Ingredient traceability and quality control

✅ Stability and contamination testing

👉 Clean Beauty Tip: Partner with a GMP-certified manufacturer to ensure consistent product quality.

6. Recalls and Adverse Events

If a product causes an adverse reaction or contamination, you must:

✅ Investigate the issue

✅ Report it to the FDA

✅ Issue a recall if necessary

👉 Example: If a batch is contaminated, trace it back to the source and notify customers promptly.

Key Takeaways

• Know whether your product is a cosmetic or a drug.

• Follow strict labeling and ingredient disclosure guidelines.

• Be careful with marketing claims to avoid drug classification.

• Choose a GMP-certified manufacturer for consistent quality.

• Have a clear plan for handling recalls and customer issues.

Need Help Navigating FDA Regulations?

We specialize in clean beauty manufacturing and can help you meet FDA standards while maintaining product integrity. Contact us today to learn more.