Labeling and Regulatory Requirements in Skincare: A Guide for Formulators

Introduction

Formulating a skincare product is only half the journey—ensuring that your product complies with labeling and regulatory requirements is equally important. Labeling not only informs consumers about the ingredients, usage, and safety of the product but also establishes transparency and trust. In this post, we’ll guide you through key labeling elements and regulatory standards, particularly focusing on the United States and European Union guidelines. By understanding these requirements, you can confidently create products that are compliant, safe, and ready for market.

Why Labeling and Compliance Matter

Regulations are in place to ensure that cosmetic products are safe for consumers and that labeling is accurate and transparent. Non-compliance can lead to recalls, legal issues, and damage to your brand’s reputation. Proper labeling also helps consumers make informed choices and builds trust by disclosing what’s in a product and how to use it safely.

Core Regulatory Bodies and Standards

1. The United States (FDA)

The U.S. Food and Drug Administration (FDA) oversees cosmetics and enforces guidelines regarding safety and labeling, but it doesn’t pre-approve cosmetics before they go to market. It’s primarily the manufacturer’s responsibility to ensure product safety and accurate labeling.

2. European Union (EU)

In the EU, cosmetics are regulated under Regulation (EC) No 1223/2009, which mandates stricter requirements than in the U.S. This regulation requires a responsible person within the EU to ensure product compliance, safety assessments, and appropriate labeling.

Key Elements of Skincare Labeling

Below are the essential labeling elements that every skincare product should include:

1. Product Name and Intended Use

Requirement: Clearly state the product name and, if not obvious, indicate the intended use (e.g., “Moisturizing Cream” or “Face Cleanser”).
Why: This helps consumers understand the product’s purpose at a glance.

2. Ingredient List (INCI Naming)

Requirement: Ingredients must be listed in descending order of concentration, using their International Nomenclature Cosmetic Ingredient (INCI) names.
Details:

Ingredients over 1% concentration must be listed in descending order.
Ingredients under 1% concentration can be listed in any order at the end.
Fragrance can be listed as “Fragrance” or “Parfum.”

Why: INCI naming ensures consistency and transparency, allowing consumers to recognize ingredients across different products.

3. Net Contents

Requirement: The amount of product (e.g., ounces or grams) must be displayed on the primary packaging.
Why: Consumers need to know the quantity they’re purchasing to make informed comparisons.

4. Directions for Use

Requirement: Provide clear instructions on how to use the product safely and effectively.
Why: Proper usage information reduces the risk of misuse or adverse reactions, ensuring the product performs as intended.

5. Warnings and Precautions

Requirement: Any potential hazards or necessary precautions should be clearly noted (e.g., “Avoid contact with eyes” or “For external use only”).
Why: Including these warnings helps prevent misuse and safeguards consumer safety, which is especially important for products with actives like AHAs or retinoids.

6. Manufacturer/Distributor Information

Requirement: Include the name and address of the manufacturer, distributor, or responsible party.
Why: This provides a point of contact for consumers and fulfills regulatory requirements for transparency and accountability.

7. Batch Number or Lot Code

Requirement: A unique batch or lot code helps track the production batch and is essential for quality control.
Why: In case of any issues or recalls, a batch number helps identify affected products.

8. Expiration Date or Period After Opening (PAO)

Requirement: For products with a limited shelf life, an expiration date or Period After Opening (PAO) symbol (e.g., “12M” for 12 months) is required.
Why: Knowing the shelf life helps consumers use the product within its effective period, maintaining safety and performance.

Detailed Breakdown of Key Labeling Elements

Ingredient Listing and INCI Compliance

INCI (International Nomenclature Cosmetic Ingredient) names are standardized names for cosmetic ingredients used across the industry. This is crucial for transparency and consistency:

Natural Ingredients: Even natural ingredients like essential oils should be listed by their INCI names (e.g., “Lavandula Angustifolia Oil” instead of “Lavender Oil”).
Complex Formulations: For complex products with active ingredients, ensure the INCI list accurately represents each component.
Labeling Small Concentrations: Ingredients below 1% can be listed in any order after those over 1%. However, actives, fragrances, and preservatives are often prioritized to show transparency.

Example: For a moisturizer with water, glycerin, and jojoba oil as main ingredients, your INCI list might look like this:

Water, Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil, Phenoxyethanol, Ethylhexylglycerin, Parfum.

Warnings and Precautions for Specific Ingredients

Some ingredients, particularly active ingredients, require special warnings. Here are examples based on common skincare actives:

AHAs and BHAs: “This product contains alpha/beta hydroxy acids that may increase your skin’s sensitivity to the sun. Use sunscreen during use and for a week after.”
Retinoids: “Do not use with other retinoid treatments. Avoid sun exposure and use sunscreen.”
Essential Oils: If an essential oil has a sensitizing potential, include a warning for those with sensitive skin.

Including these warnings protects both consumers and brands by reducing the risk of adverse reactions and promoting safe usage.

Expiration Date and Period After Opening (PAO)

An expiration date is required if a product has a shelf life of fewer than 30 months. Alternatively, a PAO (Period After Opening) symbol, typically a small open jar icon with a timeframe (e.g., 6M, 12M), indicates how long the product is safe to use after opening.

Why This Matters: Products can degrade over time, especially those containing natural ingredients or unstable actives. PAO or expiration information helps consumers use products while they’re still effective and safe.

Example: A face cream with a shelf life of 24 months might display a “12M” symbol, indicating it should be used within 12 months of opening.

Claims and Marketing Terms: Compliance with Honesty and Accuracy

Claims such as “organic,” “natural,” “non-toxic,” or “hypoallergenic” are common in skincare marketing but can be misleading if not substantiated. Here’s how to approach these terms responsibly:

Organic: Products labeled “organic” must meet specific certification standards (e.g., USDA Organic or COSMOS certification). Misuse of the term can lead to regulatory issues.
Hypoallergenic: There are no regulatory standards for this term, but it implies reduced allergen potential. Only use this if the formula minimizes common allergens and is tested for skin sensitivity.
Non-Toxic: This term is controversial and subjective. All cosmetics are required to be safe under intended use, so avoid this term unless it is supported by specific standards.

Tip: Stick to claims that are factual, such as “contains natural ingredients” or “suitable for sensitive skin,” and avoid ambiguous marketing language that could mislead consumers or attract regulatory scrutiny.

Country-Specific Requirements

United States (FDA)

Cosmetics vs. Drugs: Cosmetics can’t make therapeutic claims (e.g., “heals acne” or “reduces eczema”) without FDA approval as a drug.
Ingredient Transparency: All ingredients must be disclosed. The FDA prohibits “trade secrets” in ingredient lists for cosmetics.
Import Compliance: For international formulators, ensure compliance with FDA regulations if planning to sell in the U.S.

European Union (EU)

Responsible Person: Every product sold in the EU must have a designated “Responsible Person” to ensure compliance and act as a contact point for regulators.
Product Information File (PIF): EU regulations require a PIF that includes product formulation, safety data, and labeling. This is mandatory and must be available to regulators.
Notification Requirements: The EU’s Cosmetic Products Notification Portal (CPNP) requires brands to register products before they go to market.

Example Label Layout for a Skincare Product

Here’s an example layout for a moisturizer label:

Front of Label:

Product Name: Hydrating Face Moisturizer
Net Contents: 1.7 fl oz (50 mL)

Back of Label:

Ingredients: Water, Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil, Cetearyl Alcohol, Phenoxyethanol, Ethylhexylglycerin, Parfum.
Directions: Apply to clean skin, morning and night. Avoid eye area.
Warnings: For external use only. Discontinue if irritation occurs.
PAO/Expiration: 12M (with PAO symbol)
Manufacturer Information: XYZ Cosmetics, 123 Beauty Lane, New York, NY, USA

Key Takeaways

Ingredient Transparency: Use INCI names and list ingredients in order of concentration for transparency and regulatory compliance.
Provide Safety Information: Include warnings for potential irritants and actives to ensure consumer safety.
Understand Country-Specific Regulations: Different markets have unique requirements, so familiarize yourself with the regulations in each region where you intend to sell.
Avoid Misleading Claims: Stick to factual claims, and avoid terms that could mislead consumers or attract regulatory issues.

Final Thoughts

Clear, compliant labeling helps consumers make informed choices and enhances brand credibility. By understanding these requirements, you can ensure that your skincare products are both legally compliant and consumer-friendly. In our next post, we’ll cover pH and its importance in skincare formulations, including tips for testing and adjusting pH for optimal performance.

Stay tuned!

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