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 311 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LOreal Paris Youth Code Dark Spot Corrector Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE L'Oreal USA Products Inc a32f7458-d7ad-47e5-804d-de260c0726de 2023-12-29 Warnings Exact identifier application number: M020 LOreal Paris Infallible Up to 24 H Fresh Wear Foundation Broad Spectrum SPF 25 Sunscreen OCTINOXATE AND TITANIUM DIOXIDE L'Oreal USA Products Inc 917f6775-8f48-4b7e-9f67-253bc0c6d59e 2023-12-29 Warnings Exact identifier application number: M020 LOreal Paris Revitalift Triple Power Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 9b6adfab-cafa-4343-9c96-e187fe0986db 2023-12-29 Warnings Exact identifier application number: M020 NUDESCREEN BLUSH TINT SPF 30 - STRAWBERRY SUNBURST ZINC OXIDE SUNSCREEN Bentley Laboratories, LLC 4785585e-b623-4125-9867-8097694c7b58 2023-12-29 Warnings Exact identifier application number: M020 LOreal Paris Visible lift Serum Absolute Advanced Age Reversing Makeup Broad Spectrum SPF 17 OCTINOXATE AND TITANIUM DIOXIDE L'Oreal USA Products Inc a31dacaa-738d-4da8-95b2-4d737c526683 2023-12-29 Warnings Exact identifier application number: M020 LOreal Paris Age Perfect Cell Renewal Day Moisturizer Broad Spectrum SPF 25 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 8e294a61-97e2-4df8-8a59-7cec12c6f016 2023-12-29 Warnings Exact identifier application number: M020 NUDESCREEN BLUSH TINT SPF 30- SUNSET ROSE ZINC OXIDE SUNSCREEN Bentley Laboratories, LLC e351dff2-4237-4458-a947-b894e7b670a3 2023-12-29 Warnings Exact identifier application number: M020 LOreal Paris Wrinkle Expert Age Defense 55 Plus Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE L'Oreal USA Products Inc fa0b25a9-648a-4c7e-95c0-b7cb3dd525dd 2023-12-29 Warnings Exact identifier application number: M020 Radiant Shield Broad spectrum SPF 40 Tinted Mineral Sunscreen ZINC OXIDE CosMedical Technologies, LLC ef75cd9d-eaf5-430e-9a80-30c50da921ff 2023-12-28 Warnings Exact identifier application number: M020 SkinCeuticals Daily Brightening UV Defense Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 76e03a17-947a-492a-9e64-d3f7762de823 2023-12-28 Warnings Exact identifier application number: M020 La Roche Posay Laboratoire Dermatologique Anthelios UV Hydra Daily Invisible Broad Spectrum SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc cc61299b-5088-4cef-b90e-f5de67e46b25 2023-12-28 Warnings Exact identifier application number: M020 Maybelline New York Instant Age Rewind Eraser Treatment Makeup Broad Spectrum SPF 18 Sunscreen OCTINOXATE L'Oreal USA Products Inc ea0609be-eaa9-4b63-9f07-e2cd974e01ba 2023-12-28 Warnings Exact identifier application number: M020 Maybelline New York Fit Dewy Plus Smooth Normal to Dry Broad Spectrum SPF 18 Sunscreen OCTINOXATE L'Oreal USA Products Inc b3a37055-b58f-4c42-963b-01c1136f692d 2023-12-28 Warnings Exact identifier application number: M020 Maybelline New York Fit Me Foundation Dewy Plus Smooth SPF 18 Sunscreen OCTINOXATE L'Oreal USA Products Inc 52e169b7-3560-489e-b7ab-1fea01466c0c 2023-12-28 Warnings Exact identifier application number: M020 Maybelline New York Fit Me Matte Plus Poreless Mattifying Poreless Primer Broad Spectrum SPF 20 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE L'Oreal USA Products Inc c0c2aac2-1cd3-4e97-894c-a828fd9dba9b 2023-12-28 Warnings Exact identifier application number: M020 Maybelline New York Master Prime By Face Studio Primer Broad Spectrum SPF 30 Sunscreen OCTINOXATE LOreal USA Products Inc feabb713-4ef1-45b3-b34f-562e37b314d5 2023-12-28 Warnings Exact identifier application number: M020 SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE Tekweld Solutions, Inc. dc3f8339-23c1-4882-8682-685623027bdf 2023-12-27 Warnings Exact identifier application number: M020 Dermablend Professional Smooth Camo Medium Coverage Foundation Broad Spectrum SPF 25 Sunscreen TITANIUM DIOXIDE L'Oreal USA Products Inc aec1957a-f68d-4fbd-af9e-f8b257daea46 2023-12-27 Warnings Exact identifier application number: M020 Vichy Laboratoires Capital Soleil 60 Daily AntiAging Face and Body Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE LOreal USA Products Inc 8404ef40-35fd-4460-a35f-d473b3c04c87 2023-12-27 Warnings Exact identifier application number: M020 Dermablend Professional CC Continuous Correction Full Coverage Makeup Broad Spectrum SPF 50 Plus Sunscreen HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc c4514240-f09b-48e3-94d6-d45dc426900e 2023-12-27 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