Home NDC 58892-319 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 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 Ultra Zinc SPF 40 (Tinted)
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 200 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z 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 58892-319-01 TiZO Ultra Zinc SPF 40 (Tinted) 100 g in 1 TUBE CREAM 100 4 58892-319-01 TiZO Ultra Zinc SPF 40 (Tinted) 1 in 1 CARTON CREAM 1 4 58892-319-05 TiZO Ultra Zinc SPF 40 (Tinted) 5 g in 1 TUBE CREAM 5 1 58892-319-15 TiZO Ultra Zinc SPF 40 (Tinted) 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 58892-319 TIZO ULTRA ZINC SPF 40 (TINTED) (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] 4 Current NDC, Legacy NDC, 2 package rows 20241031_36efd48b-910e-4b61-9519-a6d5c7e9a7c3.zip 58892-319 TIZO ULTRA ZINC SPF 40 (TINTED) (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 1 Current NDC, Legacy NDC, 1 package rows 20250212_2d3faa43-0d78-58de-e063-6294a90a0b17.zip 58892-319 TIZO ULTRA ZINC SPF 40 (TINTED) (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] 1 Current NDC, Legacy NDC, 1 package rows 20250212_2d0856cf-d3da-5a77-e063-6294a90ad5b4.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 128 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58892-319-01 58892031901 1 TUBE in 1 CARTON (58892-319-01) / 100 g in 1 TUBE 1 tube 2022-03-15 0000-00-00 No No Current 58892-319-05 58892031905 5 g in 1 TUBE (58892-319-05) 5 g 2022-03-15 Yes No Current 58892-319-15 58892031915 1.5 g in 1 PACKET (58892-319-15) 1.5 g 2022-03-15 Yes No Current