Hotter Than the Sun: K-Beauty Sunscreens Face New Challenges in the U.S.

K-Beauty Sunscreens: Beloved by U.S. Consumers, Challenged by Tariffs and FDA Rules

K-Beauty sunscreens are among the most popular Korean products in the U.S. market today. American consumers consistently praise them for their lightweight textures, smooth application, and proven effectiveness. Yet, recent shifts in tariffs and regulatory requirements are creating new challenges for this growing category.

🔆 Tariff Barriers: A Test for Price Competitiveness

The U.S. government has recently scaled back de minimis exemptions and imposed tariffs of 15–25% on imported cosmetics, including Korean products. This directly translates into higher retail prices, impacting both cross-border e-commerce and brick-and-mortar distribution.

For K-Beauty brands, maintaining price competitiveness now requires both short-term measures such as securing local warehouses and inventory management, and long-term strategies like local manufacturing or OEM partnerships.

🔆 Regulatory Barriers: MoCRA and FDA’s Strict Standards

In the U.S., sunscreens are not classified as cosmetics but as OTC (over-the-counter) drugs. This means brands must adhere to FDA-approved active ingredients, dosage forms, and detailed labeling requirements. Safety and efficacy data at the level of drug products are required, and the approval process for new UV filters has been notoriously slow.

There have already been multiple cases where sunscreens containing non-FDA-approved UV filters such as Tinosorb, Uvasorb, and Mexoryl were detained at customs as “Unapproved New Drug – Sunscreen” or even delisted from online platforms. These examples highlight a critical reality: without proper validation of ingredients, formulations, and labeling, sustained growth in the U.S. market is nearly impossible.

The Path Forward: From Trend to Trusted Standard

K-Beauty sunscreens have already proven themselves with world-class technology and consumer satisfaction. But unless brands overcome both tariff and regulatory hurdles, growth can stall at any time. To ensure long-term success, brands should focus on four key priorities:

✔️ Establish compliance systems: Complete MoCRA registration, appoint a Responsible Person, and conduct FDA-compliant label reviews to build credibility with buyers and retailers.

✔️ Adapt to distribution channel requirements: For entry into Walmart, Target, Costco, or Ulta, secure registrations such as WERCSmart® and align with each platform’s compliance standards.

✔️ Manage tariff risks: Diversify supply chains, explore local production, and adopt flexible pricing strategies to mitigate financial pressures.

✔️ Build consumer trust: Clearly communicate that your sunscreen is FDA-compliant, positioning it as more than just a trend but as a trusted, long-term brand in the U.S. market.

Provision Consulting Group is an FDA-specialized consulting firm headquartered in California,

supporting Korean and global brands in entering the U.S. market for over a decade.

We provide a one-stop service covering MoCRA registration, Responsible Person representation, label review,

and retail entry consulting — helping K-Beauty sunscreens achieve stable and sustainable growth in the U.S. market.

If you have any questions or need assistance, please feel free to contact us.

Office: 1-909-493-3276

Email: ask@provisionfda.com