Sunscreen in America: Where We’ve Been, Where We Are, and What Comes Next

A CEO perspective on regulation, protection gaps, and the future of sun care

Sunscreen has long been considered a cornerstone of skin-cancer prevention and healthy aging. Yet despite decades of consumer use and public-health messaging, the U.S. sunscreen landscape has not kept pace with scientific advancements or global standards. Understanding how we arrived here—and where we are headed—helps explain why meaningful change is finally within reach.

Then: How U.S. Sunscreen Regulation Shaped Today’s Limitations

The regulatory origins of American sunscreen—and why innovation stalled

In the United States, sunscreens are legally classified as over-the-counter (OTC) drugs and regulated by the Food and Drug Administration (FDA), rather than as cosmetics as they are in Europe or Asia. This distinction matters. Drug classification subjects sunscreen active ingredients to a rigorous approval process that has remained largely unchanged since the 1990s.

As a result, the FDA has approved only 16 active UV filters for use in U.S. sunscreens under its monograph system. By comparison, European and Asian markets have access to roughly twice as many approved filters, including several that offer superior UVA protection and improved photostability.

Compounding the issue, SPF (sun protection factor) in the U.S. is primarily based on protection against UVB radiation—the rays responsible for sunburn. UVA radiation, which penetrates deeper into the skin and plays a significant role in premature aging and skin cancer risk, historically received far less regulatory emphasis. For years, U.S. sunscreens were not required to demonstrate robust UVA protection using internationally recognized testing methods.

Now: The Protection Gap Facing U.S. Consumers

Why SPF numbers often overpromise and underdeliver on UVA defense

Despite widespread daily sunscreen use, scientific evaluations have revealed a troubling disconnect between consumer expectations and real-world protection. Laboratory testing has shown that many sunscreens sold in the U.S. provide substantially less UVA protection than their SPF rating would suggest—sometimes as little as one-quarter of the implied coverage.

Compared to European and Asian formulations, American sunscreens often allow significantly more UVA radiation to pass through. The limited palette of FDA-approved UVA filters restricts manufacturers’ ability to formulate truly balanced, broad-spectrum protection across the full ultraviolet range.

This gap is not merely academic. UVA exposure is strongly linked to accelerated skin aging and meaningfully contributes to skin cancer risk. Yet for years, U.S. consumers have lacked access to some of the most effective sunscreen technologies already in widespread use abroad.

Why the U.S. Fell Behind Global Sun-Care Standards

Regulatory barriers, outdated rules, and unmet scientific potential

Three core factors explain why the U.S. sunscreen market has lagged behind global counterparts:

1. Regulatory Classification as a Drug
   Sunscreen actives must undergo a drug-like approval process, requiring extensive safety and efficacy data. While consumer safety is paramount, this framework has significantly slowed adoption of proven filters already used internationally.
2. An Outdated Sunscreen Monograph
   The FDA sunscreen monograph—the rulebook governing allowable ingredients and formulations—has not been meaningfully updated in decades. Innovation has been constrained by the inability to introduce newer, potentially superior UV filters without lengthy regulatory review.
3. Historically Narrow UVA Requirements
   Until recently, U.S. regulations did not require the same level of rigorous UVA testing or labeling standards used elsewhere, leaving consumers with an incomplete picture of actual protection.

These realities have contributed to frustration, confusion, and, at times, misinformation around sunscreen safety and effectiveness.

A Turning Point: Regulatory Momentum and Meaningful Reform

New FDA proposals, modernized standards, and renewed optimism

Encouragingly, meaningful change is now underway. In late 2025, the FDA formally proposed adding bemotrizinol—a highly effective, broad-spectrum UV filter long approved in Europe and Asia—to the list of permitted sunscreen active ingredients in the U.S. If finalized, this would mark the first major new sunscreen filter approved in more than 25 years.

Dermatologists and public-health experts have welcomed this proposal as a breakthrough, opening the door to sunscreens that offer stronger UVA protection, improved photostability, and more cosmetically elegant formulations.

At the same time, updated FDA labeling requirements now emphasize that sunscreens with SPF 15 or higher must demonstrate balanced UVA protection, and that SPF values should reflect measured, meaningful performance rather than inflated ranges.

Legislative efforts such as the SAFE Sunscreen Standards Act are also designed to modernize the FDA review process, helping accelerate access to globally accepted sunscreen ingredients while maintaining rigorous safety standards.

Next: The Future of Sunscreen Performance in the U.S.

Better filters, higher standards, and smarter consumer expectations

Looking ahead, several trends are likely to define the next era of American sun care:

• Expanded UV Filter Options
  Regulatory reform is expected to allow additional globally proven UVA filters into the U.S. market.
• Higher Performance Standards
  Improved testing and labeling will push products to deliver true broad-spectrum protection—not just high SPF numbers.
• Improved Consumer Education
  Public understanding will increasingly extend beyond SPF to include UVA coverage and overall photoprotection quality.
• Formulation Innovation
  With better filters and increased competition, sunscreens will become lighter, less greasy, and more suitable for everyday use—key to improving compliance and reducing skin-cancer risk.

Closing Perspective: A Brighter, More Protective Future for Sun Care

From legacy limitations to next-generation protection

For too long, the U.S. sun-care framework has failed to keep pace with scientific progress and international best practices. Today, that reality is changing. Regulatory reform, new ingredient approvals, and an emphasis on meaningful broad-spectrum protection signal a long-overdue shift.

For consumers, this evolution means sunscreens that do more than prevent sunburn—they better protect against premature aging, DNA damage, and skin cancer, the very harms sunscreen was created to prevent.

At Columbia SkinCare, we are conducting extensive research into next-generation sun-care development and look forward to introducing our own sunscreen products as soon as FDA approval is obtained.

Wishing everyone a happy—and healthier—New Year.