Home NDC 58892-107 TiZO Photoceutical AM Replenish Non-Tinted
Product NDC 58892-107
11-digit product format 588920107
Labeler code 58892
Product ID 58892-107_26e7189b-149f-97c4-e063-6394a90a0294
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 2018-03-05
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 Non-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 58892-107-50 TiZO Photoceutical AM Replenish Non-Tinted 50 g in 1 TUBE CREAM 50 3 58892-107-50 TiZO Photoceutical AM Replenish Non-Tinted 1 in 1 CARTON CREAM 1 3 58892-107-05 TiZO Photoceutical AM Replenish Non-Tinted 5 g in 1 TUBE CREAM 5 1 58892-107-15 TiZO Photoceutical AM Replenish Non-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 58892-107 TIZO PHOTOCEUTICAL AM REPLENISH NON-TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] 3 Current NDC, Legacy NDC, 2 package rows 20241121_c52a1e04-f3ca-47a1-a26e-d6f5e77b47d6.zip 58892-107 TIZO PHOTOCEUTICAL AM REPLENISH NON-TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] 1 Current NDC, Legacy NDC, 1 package rows 20250202_2cb77125-ff77-2060-e063-6294a90ab69f.zip 58892-107 TIZO PHOTOCEUTICAL AM REPLENISH NON-TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] 1 Current NDC, Legacy NDC, 1 package rows 20250212_2cc62961-dcef-d7db-e063-6394a90a9ebd.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 125 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Daily Defense Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE JADEIA LIMITED INC 35cf708c-244e-63a8-e063-6394a90a3b96 2025-12-15 Exact identifier application number: M020 Daily Restore ZINC OXIDE TYRLIN ENTERPRISES, INC. 35cead50-86a7-2cf2-e063-6294a90a5f99 2025-12-15 Exact identifier application number: M020 Daily Defense Facial Sunscreen Plus Primer TITANIUM DIOXIDE, ZINC OXIDE LAURA CATHERINE, LLC 36e81e8e-0ba7-93e6-e063-6294a90a4e62 2025-12-15 Exact identifier application number: M020 Sacred Aura ZINC OXIDE IRIA SKIN OASIS LLC 36eaaa54-e288-6590-e063-6394a90a403d 2025-12-15 Exact identifier application number: M020 Daily Defense Facial Sunscreen Plus Primer TITANIUM DIOXIDE, ZINC OXIDE LAURA CATHERINE, LLC 36e84147-5dcd-517a-e063-6394a90a54ee 2025-12-15 Exact identifier application number: M020 Sacred Glow ZINC OXIDE IRIA SKIN OASIS LLC 36ead65c-a46c-7395-e063-6394a90a9e04 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Non Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e91877-c4c4-7fa3-e063-6294a90a1326 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e880af-debc-657f-e063-6394a90ab6ff 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e8b631-03e7-c1de-e063-6294a90aa530 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Non Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e957cf-cfa5-b122-e063-6294a90a78ce 2025-12-15 Exact identifier application number: M020 Skin Shield Plus ZINC OXIDE LAURA CATHERINE, LLC 36e9c2f3-ea89-0de3-e063-6394a90a9fb6 2025-12-15 Exact identifier application number: M020 Skin Shield Plus ZINC OXIDE LAURA CATHERINE, LLC 36e9958b-cc5c-f7ff-e063-6394a90ac80d 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Plus Primer Matte TITANIUM DIOXIDE, ZINC OXIDE Simply Bare Waxing & Skin Care LLC 36d8e8ba-a3dd-257d-e063-6294a90a30d6 2025-12-15 Exact identifier application number: M020 Tinted Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE LAURA CATHERINE, LLC 36e9e8d7-3fcf-1e94-e063-6394a90a8dc6 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Plus Primer CPlusE Glow ZINC OXIDE Simply Bare Waxing & Skin Care LLC 36d968df-5168-61bf-e063-6294a90a94b7 2025-12-15 Exact identifier application number: M020 Advanced Sun Protection TITANIUM DIOXIDE, ZINC OXIDE HELLO BEAUTIFUL SKIN STUDIO 36d45b48-e08d-ef40-e063-6394a90a635c 2025-12-15 Exact identifier application number: M020 Advanced Sun Protection TITANIUM DIOXIDE, ZINC OXIDE HELLO BEAUTIFUL SKIN STUDIO 36d439fb-b9cf-2774-e063-6294a90ae885 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Plus Primer CPlusE Glow ZINC OXIDE Simply Bare Waxing & Skin Care LLC 36d9b48d-e3db-6ae2-e063-6294a90abbf5 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Plus Primer Matte TITANIUM DIOXIDE, ZINC OXIDE Simply Bare Waxing & Skin Care LLC 36d9d83b-7da7-a006-e063-6394a90a9d84 2025-12-15 Exact identifier application number: M020 Advanced Sun Protection TITANIUM DIOXIDE, ZINC OXIDE HELLO BEAUTIFUL SKIN & ACNE 36d3ebc0-1de6-1998-e063-6294a90a02e6 2025-12-15 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 58892-107-05 58892010705 5 g in 1 TUBE (58892-107-05) 5 g 2019-07-23 Yes No Current 58892-107-15 58892010715 1.5 g in 1 PACKET (58892-107-15) 1.5 g 2019-07-23 Yes No Current 58892-107-50 58892010750 1 TUBE in 1 CARTON (58892-107-50) / 50 g in 1 TUBE 1 tube 2019-07-23 0000-00-00 No No Current