Home NDC 68577-168 Tinted Lip Cream SPF 15
Product NDC 68577-168
11-digit product format 685770168
Labeler code 68577
Product ID 68577-168_29227121-e57a-8eea-e063-6394a90a302f
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler COSMAX USA, CORPORATION
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-01
Substance ZINC OXIDE
Active strength 9.28 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 Tinted Lip Cream SPF 15
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 9.28 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 68577-168-01 Tinted Lip Cream SPF 15 1 in 1 CARTON CREAM 1 1 68577-168-01 Tinted Lip Cream SPF 15 17 mg in 1 TUBE, WITH APPLICATOR CREAM 17 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68577-168 TINTED LIP CREAM SPF 15 (ZINC OXIDE) CREAM [COSMAX USA, CORPORATION] 1 Current NDC, 2 package rows 20241220_29227121-e579-8eea-e063-6394a90a302f.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 162 of 353 · 7,049 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68577-168-01 68577016801 1 TUBE, WITH APPLICATOR in 1 CARTON (68577-168-01) / 17 mg in 1 TUBE, WITH APPLICATOR 2024-01-01 No No Current