Home NDC 58892-326 TiZO3
Product NDC 58892-326
11-digit product format 588920326
Labeler code 58892
Product ID 58892-326_468d6476-127b-e9f0-e063-6294a90a3df9
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 2015-05-10
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 85.4; 40.7 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 52 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 58892-326-20 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 58892-326-20 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 58892-326-20 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 58892-326-20 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 58892-326-20 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 58892-326-20 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 58892-326-20 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 58892-326-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58892-326-20 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 58892-326-20 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 58892-326-20 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 58892-326-50 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 58892-326-20 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 58892-326-50 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 58892-326-20 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 58892-326-50 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 58892-326-20 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 58892-326-50 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 58892-326-20 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 58892-326-20 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 58892-326-20 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 58892-326-20 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 58892-326-20 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 58892-326-20 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 58892-326-20 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 58892-326-20 110d247fa046…a55b01930146…
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 TiZO3
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 85.4 mg/mL ZINC OXIDE 40.7 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58892-326-50 TiZO3 44.4 mL in 1 TUBE CREAM 44.4 4 58892-326-50 TiZO3 1 in 1 CARTON CREAM 1 4 58892-326-20 Solar Protection Formula TiZO3 Sunscreen 44.4 mL in 1 TUBE CREAM 44.4 2 58892-326-20 Solar Protection Formula TiZO3 Sunscreen 1 in 1 CARTON CREAM 1 2 58892-326-05 TiZO3 5 mL in 1 TUBE CREAM 5 1 58892-326-85 TiZO3 85 mL in 1 BOTTLE, PUMP CREAM 85 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Titanium Dioxide ACTIVE INGREDIENT 15FIX9V2JP SOLAR PROTECTION FORMULA TIZO3 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2 Zinc Oxide ACTIVE INGREDIENT SOI2LOH54Z SOLAR PROTECTION FORMULA TIZO3 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2 Titanium Dioxide ACTIVE MOIETY 15FIX9V2JP SOLAR PROTECTION FORMULA TIZO3 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2 Zinc Oxide ACTIVE MOIETY SOI2LOH54Z SOLAR PROTECTION FORMULA TIZO3 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2 Aluminum Oxide INACTIVE INGREDIENT LMI26O6933 SOLAR PROTECTION FORMULA TIZO3 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2 Cyclomethicone 5 INACTIVE INGREDIENT 0THT5PCI0R SOLAR PROTECTION FORMULA TIZO3 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2 Dimethicone INACTIVE INGREDIENT 92RU3N3Y1O SOLAR PROTECTION FORMULA TIZO3 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2 Ferric Oxide Red INACTIVE INGREDIENT 1K09F3G675 SOLAR PROTECTION FORMULA TIZO3 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58892-326 TIZO3 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] 4 Current NDC, Legacy NDC, 2 package rows 20241004_2e53defe-98a3-4689-8763-35d76b5701c3.zip 58892-326 SOLAR PROTECTION FORMULA TIZO3 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2 Current NDC, Legacy NDC, 2 package rows 20121208_a5d22c0f-c55b-4344-ba7f-1b40d3b7c5a3.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 178 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hello Bello Kids SPF 50 Face and Body Sunscreen Stick ZINC OXIDE Hello Bello 4127e49a-eb27-e8e2-e063-6294a90a469e 2025-10-16 Warnings Exact identifier application number: M020 ELEVEN UNRIVALED SERUM ZINC OXIDE Eco Chic, LLC f4bdacb9-bedd-c9cc-e053-2995a90a5786 2025-10-16 Warnings Exact identifier application number: M020 ELEVEN BY VENUS WILLIAMS ACE THE DAY Face ZINC OXIDE Eco-Chic LLC de438665-72d9-9b1b-e053-2a95a90ab9ef 2025-10-16 Warnings Exact identifier application number: M020 Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 6bb07f16-c3a3-49e7-ae13-718bb0055873 2025-10-16 Warnings Exact identifier application number: M020 Illuminizing Blendrops Broad Spectrum SPF 40 HOMOSALATE, OCTISALATE, ZINC OXIDE Wasatch Product Development, LLC 124e6702-97a4-95bf-e063-6394a90afc0d 2025-10-16 Warnings Exact identifier application number: M020 Perfecting Blendrops Broad Spectrum SPF 46 HOMOSALATE, OCTISALATE, ZINC OXIDE Wasatch Product Development, LLC 414c1186-6f68-3828-e063-6294a90a66cf 2025-10-16 Warnings Exact identifier application number: M020 Bronzing Blendrops Broad Spectrum SPF 46 HOMOSALATE, OCTISALATE, ZINC OXIDE Wasatch Product Development, LLC 414c2db8-3122-60d3-e063-6394a90ae1c8 2025-10-16 Warnings Exact identifier application number: M020 DD Cream DD CREAM DERMAdoctor, Inc. 08c9a0cf-ee78-483b-e054-00144ff88e88 2025-10-16 Warnings Exact identifier application number: M020 Ciele Bronze and Protect ZINC OXIDE Ciele LLC 22003cbf-5a6d-001b-e063-6394a90aefdd 2025-10-15 Warnings Exact identifier application number: M020 Ciele Blush and Protect ZINC OXIDE Ciele 0162c891-ba2d-a78f-e063-6394a90a156c 2025-10-15 Warnings Exact identifier application number: M020 Ciele Filter and Protect TITANIUM DIOXIDE, ZINC OXIDE Ciele 0309b0ef-baca-b41d-e063-6294a90a49d7 2025-10-15 Warnings Exact identifier application number: M020 Ciele Sculpt and Protect ZINC OXIDE Ciele LLC 21ff7f78-b543-0bea-e063-6294a90aed70 2025-10-15 Warnings Exact identifier application number: M020 LATHER- DAILY DEFENSE MINERAL SPF 50 BODY SUNSCREEN ZINC OXIDE Lather, Inc. 3158a2d7-0db5-f5bf-e063-6294a90a3126 2025-10-15 Warnings Exact identifier application number: M020 LATHER- DAILY DEFENSE MINERAL SPF 50 ZINC OXIDE Lather, Inc. 81cf57b0-6072-432f-b421-7d1a708da1c4 2025-10-15 Warnings Exact identifier application number: M020 Ciele Glow and Protect ZINC OXIDE Ciele Cosmetics 27310d47-de1b-2149-e063-6394a90abe83 2025-10-15 Warnings Exact identifier application number: M020 Sunforgettable Total Protection Sport Stick ZINC OXIDE Colorescience d3c0d2b0-f411-565d-e053-2a95a90a081b 2025-10-15 Warnings Exact identifier application number: M020 Defend and Balance TInted Mineral Sunscreen SPF 50 SUNSCREEN Epicuren Discovery 41367f05-59d8-6736-e063-6394a90a5f17 2025-10-15 Warnings Exact identifier application number: M020 Banana Boat AVOBENZONE HOMOSALATE OCTOCRYLENE Edgewell Personal Care Brands LLC 41376da3-5274-b133-e063-6394a90afa13 2025-10-15 Warnings Exact identifier application number: M020 Curology Daily Moisturizing Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Curology ee59d52e-5dc6-4fb4-96d8-0bda40e23009 2025-10-15 Warnings Exact identifier application number: M020 SUNFORGETTABLE TOTAL PROTECTION COLOR BALM COLLECTION ENDLESSS ENDLESS SUNSET ZINC OXIDE Colorescience f4aa14ed-6c6f-8301-e053-2a95a90a5e23 2025-10-15 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 58892-326-05 58892032605 5 mL in 1 TUBE (58892-326-05) 5 ml 2015-05-10 No No Current 58892-326-20 58892032620 44.4 mL in 1 TUBE 44.4 ml Historical 58892-326-50 58892032650 1 TUBE in 1 CARTON (58892-326-50) > 44.4 mL in 1 TUBE 1 tube 2015-03-25 0000-00-00 No No Current 58892-326-85 58892032685 85 mL in 1 BOTTLE, PUMP (58892-326-85) 85 ml 2007-05-21 No No Current