Home NDC 58892-128 TiZO Mineral Sun Defense SPF 50
Product NDC 58892-128
11-digit product format 588920128
Labeler code 58892
Product ID 58892-128_2cc8f7ef-eda4-fe71-e063-6394a90a6a9a
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 ZINC OXIDE; TITANIUM DIOXIDE
Active strength 30; 100 mg/g; mg/g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base TiZO Mineral Sun Defense SPF 50
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 30 mg/g TITANIUM DIOXIDE 100 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58892-128-50 TiZO Mineral Sun Defense SPF 50 50 g in 1 TUBE CREAM 50 2 58892-128-50 TiZO Mineral Sun Defense SPF 50 1 in 1 CARTON CREAM 1 2 58892-128-05 TiZO Mineral Sun Defense SPF 50 5 g in 1 TUBE CREAM 5 1 58892-128-15 TiZO Mineral Sun Defense SPF 50 1.5 g in 1 PACKET CREAM 1.5 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58892-128 TIZO MINERAL SUN DEFENSE SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS LTD.] 2 Current NDC, 2 package rows 20241027_e17a8c35-2d49-4c99-b154-ea673c14753e.zip 58892-128 TIZO MINERAL SUN DEFENSE SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS LTD.] 1 Current NDC, 1 package rows 20250212_2cc8f7ef-eda3-fe71-e063-6394a90a6a9a.zip 58892-128 TIZO MINERAL SUN DEFENSE SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS LTD.] 1 Current NDC, 1 package rows 20250212_2d0766a1-4091-e84a-e063-6394a90a004a.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 302 of 346 · 6,912 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58892-128-05 58892012805 5 g in 1 TUBE (58892-128-05) 5 g 2023-03-01 Yes No Current 58892-128-15 58892012815 1.5 g in 1 PACKET (58892-128-15) 1.5 g 2023-03-01 Yes No Current 58892-128-50 58892012850 1 TUBE in 1 CARTON (58892-128-50) / 50 g in 1 TUBE 1 tube 2023-03-01 No No Current