Korean Sunscreen Export to the U.S.: A Practical Guide! 📌 Part 1: Understanding Classification
- Provision Consulting Group
- 1 day ago
- 2 min read
As K-beauty continues to gain global attention, the demand for Korean cosmetics is steadily growing in the U.S. market as well. With summer just around the corner, more and more consumers are searching for high-performance Korean sunscreens.
However, compared to other cosmetic products, Korean sunscreens remain surprisingly hard to find in the U.S. market. Why is it so difficult to export Korean sunscreens to the United States, and how can these barriers be overcome?
In this blog series, we’ll break down the challenges Korean sunscreen brands face and explore practical solutions, one by one.
The first barrier Korean sunscreens encounter when preparing for export to the U.S. is a difference in product classification standards.
"Sunscreen, a cosmetic in Korea, but a drug in the United States?"
In Korea, sunscreen is classified as a functional cosmetic.This category is subject to slightly stricter standards and management processes than general cosmetics, but it still falls under the broader cosmetic category.
The Korean Ministry of Food and Drug Safety (MFDS) reviews functional cosmetics through a product-specific evaluation process, which typically takes about 4 to 6 months for approval.Product development and launch schedules are usually planned around this regulatory timeline.
In contrast, in the United States, sunscreen is classified as an OTC drug (Over-The-Counter drug) — a non-prescription medication you can buy easily at pharmacies, supermarkets, or online.
Here’s the key point: The FDA treats sunscreen as a drug, not a cosmetic.
This means the product is subject to much stricter and more complex regulations in areas such as:
Product approval
Ingredient review
Labeling requirements
Manufacturing facility registration
Stability and safety documentation
And this difference in classification isn't just a matter of paperwork — it affects everything from product development and approval procedures to marketing strategies and sales channels.
For example, in Korea, manufacturers can promote claims like "whitening," "anti-wrinkle," or "UV protection" with a simple functional cosmetic notification. However, in the U.S., you must follow the FDA’s OTC drug labeling guidelines, which strictly allow only specific terms like "SPF," "Broad Spectrum," and "Water Resistant." Any unauthorized claims could result in an FDA warning letter.
In short — even for the same sunscreen product, the regulatory environments in Korea and the U.S. are completely different.
That’s why Korean sunscreen brands preparing to enter the U.S. market must thoroughly understand both countries' classification standards and approval processes, and build their export and market strategies accordingly.
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