In the U.S. cosmetic industry, staying compliant with FDA regulations is critical for product safety, labeling, and long-term market success. While the FDA does not directly approve most cosmetic ingredients, it plays a significant regulatory role in defining what’s legally allowed—especially for actives that interact biologically with the skin.

This guide clarifies what “FDA-approved” really means in the context of cosmetic actives and highlights the ingredients most relevant for U.S. chemists in 2025.

What “FDA-Approved” Really Means in Cosmetics

The FDA does not pre-approve cosmetic formulations or general skincare actives. However, it does regulate cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act), ensuring that ingredients are safe, non-adulterated, and properly labeled.

There are two major exceptions: color additives and OTC drug ingredients (such as sunscreens), which do require direct FDA approval. For all other cosmetic ingredients, safety must be substantiated by the manufacturer based on scientific evidence and established usage limits.

Color Additives: The Only True “FDA-Approved” Cosmetic Ingredients

Colorants used in U.S. cosmetics must be FDA-approved, and in many cases, batch-certified. These include both synthetic and mineral-based pigments. Common examples:

• FD&C Blue No. 1
• D&C Red No. 7
• Iron Oxides
• Titanium Dioxide (also used as a sunscreen agent)

Chemists must ensure that approved colors are used only in permitted product types (e.g., not all are allowed around the eyes or on lips).

Sunscreen Actives: FDA-Regulated OTC Ingredients

Sunscreens are classified as OTC drugs in the U.S., and their active ingredients fall under the FDA monograph system. Chemists formulating SPF products must restrict themselves to FDA-permitted UV filters, including:

• Zinc Oxide
• Titanium Dioxide
• Avobenzone
• Octinoxate
• Octocrylene
• Homosalate

Several older sunscreen actives are being re-evaluated under the FDA’s GRASE (Generally Recognized as Safe and Effective) criteria, so monitoring regulatory updates is essential.

High-Use Cosmetic Actives Permitted in the U.S.

Although not FDA-approved, these ingredients are widely used, backed by Cosmetic Ingredient Review (CIR) safety assessments, and accepted for use in U.S. skincare formulations:

• Niacinamide – skin brightening, barrier repair
• Sodium Hyaluronate – hydration and plumping
• Lactic Acid / Glycolic Acid – AHA exfoliants (typically under 10%)
• Panthenol (Pro-Vitamin B5) – skin soothing and anti-inflammatory
• Sodium Ascorbyl Phosphate – antioxidant and brightening
• Allantoin – wound healing and calming
• Salicylic Acid – exfoliation and acne control (up to 2% in cosmetics)

Each active should be used within concentration and pH ranges supported by safety data and industry standards.

Ingredients Prohibited or Restricted by the FDA

Chemists must avoid or restrict the following substances, which are banned for cosmetic use in the U.S.:

• Mercury compounds
• Chloroform
• Methylene chloride
• Vinyl chloride
• Bithionol
• CFCs (chlorofluorocarbons)

In addition, some ingredients permitted abroad (e.g., certain preservatives or bleaching agents) may not be compliant with U.S. regulation.

Best Practices for Chemists Formulating for the U.S. Market

• Source ingredients from suppliers that provide full regulatory documentation (COA, SDS, traceability, allergen statements)
• Cross-reference all INCI names with the FDA’s Voluntary Cosmetic Registration Program (VCRP), color additive status, and CIR safety reviews
• Monitor the FDA’s rollout of the Modernization of Cosmetics Regulation Act (MoCRA), which is phasing in new compliance requirements in 2025
• For OTC products (e.g., sunscreens or acne treatments), consult the FDA monograph and adhere to required active levels and labeling language

Final Word

For cosmetic chemists formulating for the U.S. market, staying aligned with FDA expectations means choosing well-established, CIR-reviewed actives and understanding the unique regulatory treatment of colorants and OTC drugs. Ingredient transparency, traceability, and documentation are no longer optional—they’re foundational for scalable, compliant product development.

Need FDA-compliant cosmetic actives? Grand Ingredients supplies high-performance, traceable ingredients tailored to U.S. formulation needs.