TiZO Ultra Zinc SPF 40 (Tinted)

Product NDC
58892-319
11-digit product format
588920319
Labeler code
58892
Product ID
58892-319_25a288aa-1828-492a-e063-6294a90ae5c3
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Fallien Cosmeceuticals, LTD
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-15
Substance
ZINC OXIDE
Active strength
200 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 Ultra Zinc SPF 40 (Tinted)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE200 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-319-01TiZO Ultra Zinc SPF 40 (Tinted)100 g in 1 TUBECREAM1004
58892-319-01TiZO Ultra Zinc SPF 40 (Tinted)1 in 1 CARTONCREAM14
58892-319-05TiZO Ultra Zinc SPF 40 (Tinted)5 g in 1 TUBECREAM51
58892-319-15TiZO Ultra Zinc SPF 40 (Tinted)1.5 g in 1 PACKETCREAM1.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-319TIZO ULTRA ZINC SPF 40 (TINTED) (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]4Current NDC, Legacy NDC, 2 package rows20241031_36efd48b-910e-4b61-9519-a6d5c7e9a7c3.zip
58892-319TIZO ULTRA ZINC SPF 40 (TINTED) (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]1Current NDC, Legacy NDC, 1 package rows20250212_2d3faa43-0d78-58de-e063-6294a90a0b17.zip
58892-319TIZO ULTRA ZINC SPF 40 (TINTED) (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]1Current NDC, Legacy NDC, 1 package rows20250212_2d0856cf-d3da-5a77-e063-6294a90ad5b4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58892-319-01588920319011 TUBE in 1 CARTON (58892-319-01) / 100 g in 1 TUBE1 tube2022-03-150000-00-00NoNoCurrent
58892-319-05588920319055 g in 1 TUBE (58892-319-05) 5 g2022-03-15YesNoCurrent
58892-319-15588920319151.5 g in 1 PACKET (58892-319-15) 1.5 g2022-03-15YesNoCurrent