Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad Spectrum

Product NDC
84616-002
11-digit product format
846160002
Labeler code
84616
Product ID
84616-002_47d19ffb-d5da-bccf-e063-6394a90a753e
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
SEORIN COMPANY Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-13
Substance
ZINC OXIDE
Active strength
17 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad Spectrum
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE17 g/100mL

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
84616-002-01Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad Spectrum50 mL in 1 TUBECREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84616-002ROUND LAB BIRCH JUICE MILD-UP UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM (ZINC OXIDE) CREAM [SEORIN COMPANY CO., LTD.]1Current NDC, 1 package rows20240815_1e7cc417-3c57-c87c-e063-6394a90a670b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84616-002-018461600020150 mL in 1 TUBE (84616-002-01) 50 ml2024-08-13NoNoCurrent