Home NDC 68577-162 MILK TINT SPF 43 TINTED PRIMER SERUM FAIR
Product NDC 68577-162
11-digit product format 685770162
Labeler code 68577
Product ID 68577-162_29ac54d9-63fa-f42f-e063-6394a90ada3f
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form LOTION
Route TOPICAL
Labeler COSMAX USA, CORPORATION
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-01
Substance ZINC OXIDE
Active strength 12.0015 mg/100mg
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 MILK TINT SPF 43 TINTED PRIMER SERUM FAIR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 12.0015 mg/100mg
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68577-162-00 MILK TINT SPF 43 TINTED PRIMER SERUM FAIR 1 in 1 CARTON LOTION 1 1 68577-162-00 MILK TINT SPF 43 TINTED PRIMER SERUM FAIR 30 mg in 1 BOTTLE LOTION 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68577-162 MILK TINT SPF 43 TINTED PRIMER SERUM FAIR (ZINC OXIDE) LOTION [COSMAX USA, CORPORATION] 1 Current NDC, 2 package rows 20241222_29ac756b-3df7-50c9-e063-6394a90aa479.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 26 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 68577-162-00 68577016200 1 BOTTLE in 1 CARTON (68577-162-00) / 30 mg in 1 BOTTLE 1 bottle 2024-01-01 No No Current