Home NDC 74740-450 TIBENA EVERY DAY REAL SUN BLOCK
Product NDC 74740-450
11-digit product format 747400450
Labeler code 74740
Product ID 74740-450_4bbb94e5-ada3-ab07-e063-6394a90a1b01
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler KONAD CO LTD
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-09
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 9.6; 1.56 g/50mL; g/50mL
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 TIBENA EVERY DAY REAL SUN BLOCK
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 9.6 g/50mL TITANIUM DIOXIDE 1.56 g/50mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 74740-450-01 TIBENA EVERY DAY REAL SUN BLOCK 50 mL in 1 TUBE CREAM 50 2 74740-450-02 TIBENA EVERY DAY REAL SUN BLOCK 1 in 1 BOX CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 74740-450 TIBENA EVERY DAY REAL SUN BLOCK (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [KONAD CO LTD] 1 Current NDC, 2 package rows 20240924_211c9930-4f91-cf8f-e063-6394a90a97b3.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 74740-450-01 74740045001 50 mL in 1 TUBE 50 ml Historical 74740-450-02 74740045002 1 TUBE in 1 BOX (74740-450-02) / 50 mL in 1 TUBE (74740-450-01) 1 tube 2024-09-09 No No Current