Home NDC 84378-100 Zinc Oxide Perfecting Sunscreen
Product NDC 84378-100
11-digit product format 843780100
Labeler code 84378
Product ID 84378-100_5696f277-20b6-90e1-e063-6294a90a626b
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Epicuren Discovery
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-09
Substance ZINC OXIDE
Active strength 10 g/100g
NDC exclude flag No
Listing certified through 2027-12-31
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 Zinc Oxide Perfecting Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 10 g/100g
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 84378-100-74 Zinc Oxide Perfecting Sunscreen 74 g in 1 TUBE CREAM 74 1
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 84378-100-74 84378010074 74 g in 1 TUBE (84378-100-74) 74 g 2025-06-09 No No Current