Stuck in the Shade: Understanding the Challenges of Bringing New Sunscreen Ingredients to the U.S.

If you’ve shopped for sunscreen in the United States, you’ve likely noticed a limited range of

active ingredients on the label. You’d be forgiven for wondering why Americans don’t have

access to the latest, greatest sunscreen innovations that the rest of the world seems to be

enjoying. The truth is, bringing new sunscreen ingredients to the U.S. market is a

challenging—and sometimes unrewarding—feat for companies. Here’s why your favorite

sunscreens are stuck in a bit of an innovation rut and what it all means for the U.S. sunscreen

industry.

Sunscreens as OTC Drugs: The Regulatory Labyrinth

In the United States, sunscreen isn’t just a cosmetic—it’s regulated as an over-the-counter

(OTC) drug, which means it’s subject to FDA oversight with strict safety requirements. While

other countries treat sunscreens as cosmetics (which makes them easier to bring to market),

the FDA requires that U.S. sunscreen ingredients be proven both safe and effective to a high

degree—on par with many prescription drugs. This is why those cutting-edge, photostable filters

like Tinosorb S and Uvinul A Plus, which are beloved in the EU and Australia, are absent from

the shelves in the United States.

No Exclusivity = No Incentive to Innovate

Here’s where it gets tricky: for all the effort it takes to get an ingredient approved, companies

don’t receive any exclusivity once it finally makes it to market. Unlike a new drug with patent

protections or market exclusivity, a new sunscreen ingredient approved by the FDA becomes

fair game for all companies to use. Imagine spending years and millions of dollars on approval,

only to have competitors benefit for free. Not the best business incentive, right? This lack of IP

protection leaves sunscreen companies saying, “Why bother?” when it comes to putting new

sunscreen filters through the FDA’s gauntlet.

FDA’s Rigorous Data Requirements: High Cost, Low Reward

The FDA is particularly stringent about safety data for sunscreen ingredients, and that includes

data on systemic absorption, long-term health effects, and more. This can be costly and

complex to obtain, especially for ingredients already approved and widely used in the global

market. Companies have to provide safety data specifically for U.S. approval—even if that

ingredient has been safely used for decades overseas. Add in the years-long wait time for FDA

evaluation, and companies are often left looking for faster, more profitable routes to market new

products.

The Competitive “First-Mover” Advantage Isn’t So Simple Here

When it comes to marketing in the U.S., sunscreen companies often rely on a “first-mover”

advantage: if they’re the first to get a novel ingredient or formulation approved, they can potentially capture loyal customers before competitors catch up. But here’s the problem:

sunscreen consumers aren’t as tuned into ingredient differences as they are with, say, anti-

aging actives or hydrating ingredients. U.S. consumers generally recognize SPF ratings but

aren’t always aware that their sunscreen options are behind the times compared to international

markets. And because companies can’t patent a “first-mover” sunscreen ingredient without

exclusivity, they don’t see a high return on this advantage.

How Companies Get Around the FDA with Reformulations

Without new filters on the horizon, U.S. companies have become experts at reformulating with

existing FDA-approved ingredients. Brands create novel combinations, textures, or delivery

systems (think SPF sprays, sticks, or mineral/chemical blends) to keep things interesting and

meet demand for new sunscreen types. But innovation can only go so far when you’re working

with the same active ingredients from the FDA’s established sunscreen monograph. It’s like

trying to make a new recipe using the same ten ingredients—sooner or later, you run out of

fresh ideas.

Are We Stuck with the Same Old Sunscreen Ingredients Forever?

Not necessarily! The 2020 CARES Act aimed to streamline the FDA’s OTC approval process,

but changes in sunscreen approvals have been slow. Until the U.S. regulatory framework

catches up, brands are likely to continue focusing on SPF innovation outside of active

ingredients—think lightweight textures, environmentally friendly formulations, and multifunctional

SPF products with skin-loving benefits. The U.S. sunscreen industry could see new ingredient approvals if the FDA adopts a more cosmetic-like approval process for sunscreens, as the EU and Australia do. For now, though, the process remains highly regulated, and without exclusivity rights, it’s a risky investment for companies.

So, What’s a Sunscreen Brand (or Consultant) to Do?

For brands navigating the sunscreen landscape in the U.S., it’s all about making the most of

what you have. Reformulate, create standout textures, and educate consumers on why

sunscreens on the U.S. market are safe, effective, and essential. And if you’re feeling stuck, a

cosmetic regulatory consultant can help you make sense of FDA guidelines, strategize

reformulations, and optimize your products for compliance.

Until the FDA updates its sunscreen approval process, the U.S. sunscreen industry will remain a

bit behind on new active ingredients. But with a savvy approach, you can make your sunscreen

products stand out—even in a somewhat “ingredient-stuck” market.

*Need guidance on navigating U.S. sunscreen regulations or staying compliant in a competitive

market? TAVA Consulting is here to help. Reach out for expert advice, tailored to the intricacies

of the sunscreen industry in the United States.*