Home NDC 84378-104 Defend and Balance TInted Mineral Sunscreen SPF 50
Product NDC 84378-104
11-digit product format 843780104
Labeler code 84378
Product ID 84378-104_41367f05-59d9-6736-e063-6394a90a5f17
Type HUMAN OTC DRUG
Nonproprietary name Sunscreen
Dosage form CREAM
Route TOPICAL
Labeler Epicuren Discovery
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-10-15
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 4; 15.5 g/100g; g/100g
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 Defend and Balance TInted Mineral Sunscreen SPF 50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 4 g/100g ZINC OXIDE 15.5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup 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 84378-104-28 Defend and Balance TInted Mineral Sunscreen SPF 50 28 g in 1 BOTTLE, PUMP CREAM 28 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 84378-104-28 84378010428 28 g in 1 BOTTLE, PUMP (84378-104-28) 28 g 2025-10-15 No No Current