FDA.reportPublic FDA data

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
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
1.56; 9.6 g/50mL; g/50mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
IngredientStrength
TITANIUM DIOXIDE1.56 g/50mL
ZINC OXIDE9.6 g/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74740-450-01TIBENA EVERY DAY REAL SUN BLOCK50 mL in 1 TUBECREAM502
74740-450-02TIBENA EVERY DAY REAL SUN BLOCK1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74740-450TIBENA EVERY DAY REAL SUN BLOCK (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [KONAD CO LTD]1Current NDC, 2 package rows20240924_211c9930-4f91-cf8f-e063-6394a90a97b3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
74740-450-017474004500150 mL in 1 TUBE50 mlHistorical
74740-450-02747400450021 TUBE in 1 BOX (74740-450-02) / 50 mL in 1 TUBE (74740-450-01) 1 tube2024-09-09NoNoHistorical