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 165 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aspen Islanders Sheer Mineral Sport ZINC OXIDE Aspen Islanders LLC 0fcb2adf-71c9-3369-e063-6294a90aa806 2025-11-14 Warnings Exact identifier application number: M020 By the Beach Suncare SPF 30 SUNCARE MALON DAZE By the Beach Suncare LLC 4391728b-dfe7-3ffb-e063-6394a90a240e 2025-11-14 Warnings Exact identifier application number: M020 By the Beach Suncare SPF 30 SUNCARE CITRUS CRUSH By the Beach Suncare LLC 43918d25-e947-5e17-e063-6394a90ada7c 2025-11-14 Warnings Exact identifier application number: M020 By the Beach Suncare SPF 30 SUNCARE CANDY CLOUDS By the Beach Suncare LLC 4391728b-dfe8-3ffb-e063-6394a90a240e 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Balance and Clear ZINC OXIDE Sunsolve MD Inc 26f3595d-adef-a8a5-e063-6394a90adfd4 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Detox and Shield ZINC OXIDE Sunsolve MD Inc 26f3886b-a3a5-c9b7-e063-6394a90af6c3 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Amber 002 ZINC OXIDE Sunsolve MD Inc 26e00001-9c68-0734-e063-6394a90a1787 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Agate 003 ZINC OXIDE Sunsolve MD Inc 26e00001-9c6f-0734-e063-6394a90a1787 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Bronzite 004 ZINC OXIDE Sunsolve MD Inc 26e13356-9ab5-246a-e063-6394a90a2a70 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Onyx 006 ZINC OXIDE Sunsolve MD Inc 26e16b5e-dd2e-6fb8-e063-6394a90a6a7f 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Calm and Revitalize ZINC OXIDE Sunsolve MD Inc 26f3f534-a305-3530-e063-6394a90a75e1 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Garnet 005 ZINC OXIDE Sunsolve MD Inc 26e1508f-d386-329b-e063-6394a90a0a98 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Firm and Replenish ZINC OXIDE Sunsolve MD Inc 26f3417b-9ea4-e577-e063-6294a90ae53c 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Correct and Fade ZINC OXIDE Sunsolve MD Inc 26f3ad9f-f8ca-05d4-e063-6394a90ad5c4 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Volumize and Condition Lip ZINC OXIDE Sunsolve MD 396b7462-d597-4bf7-e063-6394a90ab58d 2025-11-14 Warnings Exact identifier application number: M020 Sunsovle MD Volumize and Restore ZINC OXIDE Sunsolve MD Inc 26f3cdda-b990-15cb-e063-6394a90ade29 2025-11-14 Warnings Exact identifier application number: M020 Naturium Dew-Glow Moisturizer SPF 50 HOMOSALATE, OCTISALATE, AVOBENZONE e.l.f. Cosmetics, Inc 0a5b80fb-caeb-eb56-e063-6294a90a238b 2025-11-14 Warnings Exact identifier application number: M020 Naturium Dew Glow Tinted Moisturizer SPF50 HOMOSALATE, OCTISALATE, AVOBENZONE e.l.f. Cosmetics, Inc. 0d82f310-f87a-f76d-e063-6294a90af251 2025-11-14 Warnings Exact identifier application number: M020 Naturium Dew Glow Tinted Moisturizer SPF50-deep HOMOSALATE, OCTISALATE, AVOBENZONE e.l.f. Cosmetics, Inc. 0d865e74-1baf-6a44-e063-6394a90a37ac 2025-11-14 Warnings Exact identifier application number: M020 Naturium Dew Glow Tinted Moisturizer SPF50-medium HOMOSALATE, OCTISALATE, AVOBENZONE e.l.f. Cosmetics, Inc. 0d8616a8-2eab-c85c-e063-6294a90a3984 2025-11-14 Warnings Exact identifier application number: M020
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