Understanding Sunscreen Regulations in the United States: FDA Guidelines, SPF Testing, and Labeling Requirements

by | Mar 8, 2025 | Articles

Introduction

Sunscreens in the United States are regulated by the Food and Drug Administration (FDA) as over-the-counter (OTC) drugs. This classification means that sunscreen products must comply with strict formulation, testing, and labeling requirements to ensure they provide the level of sun protection claimed on their packaging.

For sunscreen brands looking to enter or expand within the U.S. market, understanding FDA regulations is essential. This article provides a detailed breakdown of FDA sunscreen guidelines, including SPF testing standards, labeling requirements, active ingredient regulations, and marketing restrictions.

Official FDA Sunscreen Regulations: FDA Sunscreen Final Rule

FDA Classification of Sunscreens in the United States

Unlike in many other countries where sunscreens are classified as cosmetics, the FDA categorizes sunscreens as drugs because they make a therapeutic claim—protecting the skin from sunburn and reducing the risk of skin cancer.

Monograph vs. New Drug Approval (NDA) Pathways

Sunscreens in the U.S. can be marketed in two ways:

  1. Monograph-compliant products: These follow the FDA’s Over-the-Counter (OTC) Sunscreen Monograph, which specifies approved active ingredients, SPF limits, and labeling requirements. If a product complies with these guidelines, it does not require additional FDA approval.
  2. New Drug Application (NDA): If a sunscreen contains active ingredients not included in the monograph or has a novel formulation, it must undergo the FDA’s New Drug Approval (NDA) process, which involves clinical testing and extensive safety reviews.

Official FDA OTC Sunscreen Monograph: FDA Sunscreen Monograph

Sunscreen Innovation and FDA Approval Delays

The FDA’s reluctance to approve new UV filters has been a major industry challenge. Many modern sunscreen filters used in Europe and Asia, such as Tinosorb S and Mexoryl SX, are not approved in the U.S. due to delays in the FDA review process.

FDA-Approved Sunscreen Active Ingredients

The FDA has approved only 16 UV filters for use in sunscreens, divided into chemical and physical (mineral) filters:

Chemical Filters Physical (Mineral) Filters
Avobenzone Zinc Oxide
Oxybenzone Titanium Dioxide
Octinoxate  
Octisalate  
Homosalate  
Octocrylene  

Official FDA List of Sunscreen Ingredients: FDA Approved Sunscreen Ingredients

Ingredient Restrictions and Controversies

  • Oxybenzone and Octinoxate: Some states, like Hawaii and Florida, have banned sunscreens containing these filters due to their potential harm to coral reefs.
  • Avobenzone Stability Issues: Must be combined with stabilizers like Octocrylene to prevent degradation.
  • Mineral Sunscreens: Zinc oxide and titanium dioxide are considered safer alternatives, but they can leave a white cast, which affects consumer preference.

FDA SPF Testing Standards

The FDA mandates strict SPF testing protocols to ensure sunscreens provide the protection they claim.

Key Testing Methods

  1. SPF Testing (Sunburn Protection Factor)
    1. Must be tested in vivo on human skin.
    2. Measures UVB protection by assessing how long the sunscreen delays sunburn compared to unprotected skin.
  2. Broad-Spectrum Testing (UVA & UVB Protection)
    1. Required for products claiming broad-spectrum protection.
    2. Uses a critical wavelength test (≥ 370 nm) to confirm UVA coverage.
  3. Water Resistance Testing
    1. Two FDA-approved levels: 40 minutes or 80 minutes.
    2. Sunscreens cannot claim to be waterproof or sweatproof—they must specify a water resistance duration based on testing.

Official FDA SPF Testing Standards: FDA Sunscreen Testing Guidelines

SPF Labeling Restrictions

  • Maximum SPF claim capped at SPF 60+ (no proven benefit beyond this level).
  • SPF values below 15 cannot claim to reduce skin cancer risk—only sunburn protection.

FDA Sunscreen Labeling Requirements

To ensure transparency and prevent misleading claims, the FDA requires specific labeling elements on all sunscreen packaging.

Mandatory Labeling Information

  1. SPF Value – Must be prominently displayed.
  2. Broad-Spectrum Claim – Allowed only if the product passes UVA testing.
  3. Water Resistance Statement – Must specify “Water-Resistant (40 minutes)” or “Water-Resistant (80 minutes)” if applicable.
  4. Drug Facts Panel – Lists active ingredients, purpose, usage instructions, and warnings.
  5. Warning Statements – Must include:“Skin Cancer/Skin Aging Alert” for SPF below 15.
    1. “Reapply at least every two hours” for all products.

Official FDA Labeling Requirements: FDA Labeling and Marketing Guidelines

Prohibited Claims

The FDA strictly prohibits misleading sunscreen marketing:

  • “Waterproof” or “Sweatproof” – Not allowed; only “Water-Resistant” with time limits is permitted.
  • “Sunblock” – Misleading and banned.
  • “Instant Protection” – Sunscreens take time to absorb, so this claim is not permitted.
  • “All-Day Protection” – Must specify reapplication every two hours.

Compliance Challenges for Sunscreen Brands

Navigating FDA regulations can be complex for sunscreen brands entering the U.S. market. Common challenges include:

  • Ingredient restrictions – Newer, more effective UV filters used in Europe and Asia are not FDA-approved.
  • SPF testing costs – In vivo SPF testing is expensive and time-consuming.
  • State-specific bans – Hawaii, Florida, and other regions have additional restrictions on certain chemical UV filters.
  • Marketing limitations – Strict regulations on advertising claims limit flexibility in consumer messaging.

To ensure compliance, brands must work with regulatory consultants, third-party testing labs, and legal advisors before launching sunscreen products in the U.S.

Conclusion

The FDA sunscreen regulations are among the most stringent in the world, classifying sunscreens as OTC drugs, requiring in vivo SPF testing, and imposing strict labeling guidelines to ensure product safety and effectiveness.

For sunscreen brands aiming to enter the U.S. market, understanding the FDA’s active ingredient approvals, SPF testing protocols, and labeling restrictions is essential for compliance and consumer trust. While regulatory hurdles exist, brands that navigate these challenges successfully can establish themselves in one of the world’s largest sunscreen markets.

For more details, refer to the FDA’s official sunscreen regulations: FDA Sunscreen Regulations