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

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
IngredientStrength
ZINC OXIDE22.28325 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84616-004-01Round Lab Birch Juice Moisturizing UVLOCK Sun Cushion15 g in 1 CONTAINERSPONGE151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84616-004ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUN CUSHION (ZINC OXIDE) SPONGE [SEORIN COMPANY CO., LTD.]1Current NDC, 1 package rows20250116_26407b83-b417-6450-e063-6294a90ad2b1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84616-004-018461600040115 g in 1 CONTAINER (84616-004-01) 15 g2024-11-06NoNoHistorical