CoTZ Face Prime and Protect SPF 40 (Tinted)

Product NDC
58892-354
11-digit product format
588920354
Labeler code
58892
Product ID
58892-354_87f5edec-e860-418b-99d8-317d57624d1b
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
2012-06-26
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
80; 38 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
CoTZ Face Prime and Protect SPF 40 (Tinted)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE80 mg/g
ZINC OXIDE38 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-354-45CoTZ Face Prime and Protect SPF 40 (Tinted)1 in 1 CARTONCREAM12
58892-354-45CoTZ Face Prime and Protect SPF 40 (Tinted)42.5 g in 1 TUBECREAM42.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-354COTZ FACE PRIME AND PROTECT SPF 40 (TINTED) (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]2Current NDC, Legacy NDC, 2 package rows20250124_1088fbf6-5790-490d-b272-ec281b4b76fa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58892-354-45588920354451 TUBE in 1 CARTON (58892-354-45) / 42.5 g in 1 TUBE1 tube2021-05-010000-00-00NoNoCurrent