TiZO2

Product NDC
58892-336
11-digit product format
588920336
Labeler code
58892
Product ID
58892-336_509cad98-0322-2a0a-e063-6294a90a6ea9
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Fallien Cosmeceuticals Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-04-27
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
85.4; 40.7 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TiZO2
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE85.4 mg/mL
ZINC OXIDE40.7 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-336-50TiZO250 mL in 1 TUBECREAM504
58892-336-50TiZO21 in 1 CARTONCREAM14
58892-336-45TiZO244.4 mL in 1 TUBECREAM44.43
58892-336-45TiZO21 in 1 CARTONCREAM13
58892-336-05TiZO25 mL in 1 TUBECREAM51
58892-336-15TiZO21.5 mL in 1 PACKETCREAM1.51

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-336TIZO2 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]4Current NDC, Legacy NDC, 2 package rows20241004_43bec652-3f2c-4671-8a0c-c4c4a4bfcc7a.zip
58892-336SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]2Current NDC, Legacy NDC, 2 package rows20121208_30468afc-9616-4765-b046-12e97a0a7827.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58892-336-05588920336055 mL in 1 TUBE (58892-336-05) 5 ml2015-04-27NoNoCurrent
58892-336-15588920336151.5 mL in 1 PACKET (58892-336-15) 1.5 ml2015-04-27NoNoCurrent
58892-336-455889203364544.4 mL in 1 TUBE44.4 mlHistorical
58892-336-50588920336501 TUBE in 1 CARTON (58892-336-50) / 50 mL in 1 TUBE1 tube2015-04-270000-00-00NoNoCurrent