Home NDC 85377-208 Tinted Replenishing Daily Protection
Product NDC 85377-208
11-digit product format 853770208
Labeler code 85377
Product ID 85377-208_45ffabea-6e6f-930a-e063-6294a90a6df1
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler MANTRA WELLNESS SPA
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-03-31
Substance ZINC OXIDE
Active strength 160 mg/g
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 Replenishing Daily Protection
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 160 mg/g
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 85377-208-15 Tinted Replenishing Daily Protection 1.5 g in 1 PACKET CREAM 1.5 2 85377-208-50 Tinted Replenishing Daily Protection 50 g in 1 BOTTLE, PUMP CREAM 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85377-208 TINTED REPLENISHING DAILY PROTECTION (ZINC OXIDE) CREAM [MANTRA WELLNESS SPA] 1 Current NDC, 1 package rows 20250426_338aa5a2-29e3-fe0e-e063-6294a90a18fd.zip 85377-208 TINTED REPLENISHING DAILY PROTECTION (ZINC OXIDE) CREAM [MANTRA WELLNESS SPA] 1 Current NDC, 1 package rows 20250426_33898415-4ee6-a384-e063-6394a90ae8e1.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 85377-208-15 85377020815 1.5 g in 1 PACKET (85377-208-15) 1.5 g 2023-03-31 Yes No Current 85377-208-50 85377020850 50 g in 1 BOTTLE, PUMP (85377-208-50) 50 g 2023-03-31 No No Current