FDA.reportPublic FDA data

PROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreen

Product NDC
58892-202
11-digit product format
588920202
Labeler code
58892
Product ID
58892-202_1ce89dd7-a723-f27f-e063-6294a90affbc
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
2024-07-10
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
PROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreen
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
58892-202-50PROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreen53 g in 1 BOTTLE, PUMPCREAM531

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-202PROCEUTICALS PRIVATE LABEL BY TIZO NON-TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]1Current NDC, 1 package rows20240711_1ce8c1da-565d-5487-e063-6294a90a1bde.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58892-202-505889202025053 g in 1 BOTTLE, PUMP (58892-202-50) 53 g2024-07-10NoNoCurrent