Understanding Sunscreen Regulations in Japan and South Korea: SPF Testing, PA Ratings, and Labeling Standards

by | Mar 9, 2025 | Articles

Introduction

Japan and South Korea are among the most advanced sunscreen markets, known for their innovative formulations, lightweight textures, and high UVA protection standards. Unlike the United States, where sunscreens are classified as over-the-counter (OTC) drugs, Japan and South Korea regulate sunscreens as quasi-drugs or functional cosmetics, which allows for more flexibility in UV filter approvals and marketing claims.

Both countries follow strict SPF and PA testing protocols, but their regulatory bodies, approval processes, and labeling requirements differ. This article explores the key sunscreen regulations in Japan and South Korea, covering SPF testing methods, PA grading systems, and compliance challenges for international brands.

1 Sunscreen Classification and Regulatory Authorities

Japan: Ministry of Health, Labour and Welfare (MHLW)

Sunscreens in Japan are classified into two categories:

  1. Quasi-drugs (Iyaku-bugaihin) – Require pre-market approval and are subject to strict efficacy and safety testing.
  2. Cosmetics (Keshouhin) – Do not require pre-market approval but must comply with general cosmetic safety regulations.

Most high-SPF sunscreens in Japan fall under the quasi-drug category, meaning they must be approved by the Pharmaceuticals and Medical Devices Agency (PMDA) before they can be sold.

South Korea: Ministry of Food and Drug Safety (MFDS)

In South Korea, sunscreens are classified as functional cosmetics, which means they:

  • Require pre-market approval from the MFDS.
  • Must undergo SPF and PA testing in certified local laboratories.
  • Are subject to strict ingredient safety assessments.

Unlike Japan, all sunscreens in South Korea, regardless of SPF level, require regulatory approval before they can enter the market.

2 Approved UV Filters in Japan and South Korea

Both Japan and South Korea allow a broader range of UV filters compared to the United States, but their lists differ slightly from the European Union’s approved filters.

Japan: Approved UV Filters

Japan’s Ministry of Health, Labour and Welfare (MHLW) allows 30+ approved UV filters, including:

  • Avobenzone
  • Octinoxate
  • Octocrylene
  • Uvinul A Plus
  • Uvinul T 150
  • Tinosorb S
  • Tinosorb M
  • Mexoryl SX

Japan also permits nano zinc oxide and titanium dioxide, which offer better UVA protection while reducing the white cast commonly associated with mineral sunscreens.

South Korea: Approved UV Filters

South Korea’s MFDS has a slightly different list of approved filters, including:

  • Avobenzone
  • Octinoxate
  • Octocrylene
  • Homosalate
  • Uvinul A Plus
  • Uvinul T 150
  • Tinosorb S
  • Tinosorb M
  • Mexoryl SX
  • Polysilicone-15

Both countries ban oxybenzone and PABA (para-aminobenzoic acid) due to safety concerns.

3 SPF Testing and PA Grading System

Both Japan and South Korea use SPF and PA ratings to measure UVB and UVA protection, but their testing standards and classification methods differ slightly.

SPF Testing Standards

  • Japan follows the ISO 24444 standard for in vivo SPF testing, which is also used in the EU and China.
  • South Korea follows the MFDS-approved SPF test, which is similar to the ISO 24444 standard but requires testing in certified local labs.

PA Rating System for UVA Protection

Japan developed the PA (Protection Grade of UVA) system, which South Korea later adopted. This system categorizes UVA protection based on the Persistent Pigment Darkening (PPD) test.

PA Rating UVA Protection Level
PA+ Some UVA protection (PPD 2-4)
PA++ Moderate UVA protection (PPD 4-8)
PA+++ High UVA protection (PPD 8-16)
PA++++ Very high UVA protection (PPD 16+)

A PA++++ rating, commonly found in Japanese and Korean sunscreens, offers one of the highest levels of UVA protection available globally.

4 Water Resistance and Additional Testing

Japan and South Korea also have strict water resistance testing requirements:

  • Water-resistant claims must be proven through testing that measures SPF retention after water exposure.
  • Unlike the FDA’s 40-minute and 80-minute water resistance categories, Japan and South Korea use a single “Water-Resistant” designation if the sunscreen maintains at least 50% of its original SPF after immersion.
  • Sweat resistance testing is also conducted for sunscreens marketed for outdoor sports or humid climates.

5 Mandatory Labeling Requirements

Japan and South Korea have clear labeling requirements to ensure consumers understand the sun protection levels of a product.

Required Information on Sunscreen Packaging

  1. SPF Value – Clearly displayed on the front of the packaging.
  2. PA Rating – Required for UVA protection claims.
  3. Broad-Spectrum Claim – Allowed only if the product passes SPF and PA testing.
  4. Usage Instructions – Labels must include reapplication guidelines.
  5. Expiration Date – Required on all sunscreen packaging.
  6. Ingredient List – Must follow Japan’s INCI standards or Korea’s MFDS ingredient regulations.
  7. Manufacturer or Importer Information – Required for foreign brands entering the market.

Prohibited Claims

  • “Waterproof” or “Sweatproof” – These terms are banned; only “Water-Resistant” is allowed with test results.
  • “Sunblock” – Misleading and not permitted.
  • “All-Day Protection” – Reapplication is always necessary.

Unlike the FDA, Japan and South Korea allow sunscreens to claim SPF levels above 50, with many products labeled as SPF 50+ or even SPF 100.

6 Compliance Challenges for Foreign Brands

International sunscreen brands looking to enter Japan and South Korea face several regulatory challenges:

  1. Pre-market Approval Process – Sunscreens require registration with the MHLW (Japan) or MFDS (Korea) before being sold.
  2. SPF and PA Testing in Local Labs – Imported sunscreens must be retested in certified domestic laboratories, even if they have been tested in other countries.
  3. Ingredient Restrictions – Some EU and U.S.-approved UV filters are not permitted in Japan and South Korea.
  4. Labeling and Language Requirements – Sunscreens must comply with local labeling laws, and packaging must include instructions in Japanese or Korean.
  5. Competitive Market – The domestic sunscreen industry is highly competitive, with local brands dominating the market due to favorable regulatory conditions.

Conclusion

Japan and South Korea have some of the most advanced sunscreen regulations in the world, requiring strict SPF and PA testing, clear labeling standards, and pre-market approval.

For brands entering these markets, compliance with SPF and PA testing, ingredient restrictions, and labeling laws is essential. While Japan and South Korea allow more innovative UV filters than the U.S., regulatory hurdles, local testing requirements, and competitive market conditions present challenges for international companies.

However, given the strong consumer demand for high-performance sunscreens, brands that successfully navigate these regulations can gain access to two of the most lucrative sun care markets in Asia.