TiZO Mineral Sun Defense SPF 50

Product NDC
58892-128
11-digit product format
588920128
Labeler code
58892
Product ID
58892-128_255398db-bb8d-3d6e-e063-6394a90a2550
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
2023-03-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
100; 30 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TiZO Mineral Sun Defense SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE100 mg/g
ZINC OXIDE30 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-128-50TiZO Mineral Sun Defense SPF 5050 g in 1 TUBECREAM502
58892-128-50TiZO Mineral Sun Defense SPF 501 in 1 CARTONCREAM12
58892-128-05TiZO Mineral Sun Defense SPF 505 g in 1 TUBECREAM51
58892-128-15TiZO Mineral Sun Defense SPF 501.5 g in 1 PACKETCREAM1.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-128TIZO MINERAL SUN DEFENSE SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS LTD.]2Current NDC, 2 package rows20241027_e17a8c35-2d49-4c99-b154-ea673c14753e.zip
58892-128TIZO MINERAL SUN DEFENSE SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS LTD.]1Current NDC, 1 package rows20250212_2cc8f7ef-eda3-fe71-e063-6394a90a6a9a.zip
58892-128TIZO MINERAL SUN DEFENSE SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS LTD.]1Current NDC, 1 package rows20250212_2d0766a1-4091-e84a-e063-6394a90a004a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58892-128-05588920128055 g in 1 TUBE (58892-128-05) 5 g2023-03-01YesNoCurrent
58892-128-15588920128151.5 g in 1 PACKET (58892-128-15) 1.5 g2023-03-01YesNoCurrent
58892-128-50588920128501 TUBE in 1 CARTON (58892-128-50) / 50 g in 1 TUBE1 tube2023-03-01NoNoCurrent