Home NDC 84616-004 Round Lab Birch Juice Moisturizing UVLOCK Sun Cushion
Product NDC 84616-004
11-digit product format 846160004
Labeler code 84616
Product ID 84616-004_26407b83-b418-6450-e063-6294a90ad2b1
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form SPONGE
Route TOPICAL
Labeler SEORIN COMPANY Co., Ltd.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-11-06
Substance ZINC OXIDE
Active strength 22.28325 g/100g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Round Lab Birch Juice Moisturizing UVLOCK Sun Cushion
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 22.28325 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84616-004-01 Round Lab Birch Juice Moisturizing UVLOCK Sun Cushion 15 g in 1 CONTAINER SPONGE 15 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84616-004 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUN CUSHION (ZINC OXIDE) SPONGE [SEORIN COMPANY CO., LTD.] 1 Current NDC, 1 package rows 20250116_26407b83-b417-6450-e063-6294a90ad2b1.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 45 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84616-004-01 84616000401 15 g in 1 CONTAINER (84616-004-01) 15 g 2024-11-06 No No Current