Home NDC 58892-101 TiZO Photoceutical AM Replenish - Tinted
Product NDC 58892-101
11-digit product format 588920101
Labeler code 58892
Product ID 58892-101_26bde5bd-1ffa-91f1-e063-6294a90adaf6
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 2015-10-13
Substance ZINC OXIDE
Active strength 160 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 Photoceutical AM Replenish - Tinted
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 160 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 58892-101-50 TiZO Photoceutical AM Replenish - Tinted 1 in 1 CARTON CREAM 1 3 58892-101-50 TiZO Photoceutical AM Replenish - Tinted 50 g in 1 TUBE CREAM 50 3 58892-101-05 TiZO Photoceutical AM Replenish - Tinted 5 g in 1 TUBE CREAM 5 1 58892-101-15 TiZO Photoceutical AM Replenish - Tinted 1.5 g in 1 PACKET CREAM 1.5 1 58892-101-30 TIZO PHOTOCEUTICAL AM REPLENISH - TINTED 30 g in 1 TUBE CREAM 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58892-101 TIZO PHOTOCEUTICAL AM REPLENISH - TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] 3 Current NDC, Legacy NDC, 2 package rows 20241115_fbafa468-fce0-4597-bcb0-a816dc71ec7c.zip 58892-101 TIZO PHOTOCEUTICAL AM REPLENISH - TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] 1 Current NDC, Legacy NDC, 1 package rows 20250212_2cc73c4f-30ea-0a51-e063-6394a90ac9a4.zip 58892-101 TIZO PHOTOCEUTICAL AM REPLENISH - TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] 1 Current NDC, Legacy NDC, 1 package rows 20250212_2cc84aba-006b-a78e-e063-6294a90ae040.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 27 of 361 · 7,213 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 58892-101-05 58892010105 5 g in 1 TUBE (58892-101-05) 5 g 2019-07-23 Yes No Current 58892-101-15 58892010115 1.5 g in 1 PACKET (58892-101-15) 1.5 g 2019-07-23 Yes No Current 58892-101-30 58892010130 30 g in 1 TUBE (58892-101-30) 30 g 2015-10-13 No No Current 58892-101-50 58892010150 1 TUBE in 1 CARTON (58892-101-50) / 50 g in 1 TUBE 1 tube 2019-07-23 0000-00-00 No No Current