Home NDC 58892-336 TiZO2
Product NDC 58892-336
11-digit product format 588920336
Labeler code 58892
Product ID 58892-336_509cad98-0322-2a0a-e063-6294a90a6ea9
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 2015-04-27
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 40.7; 85.4 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 · 50 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 58892-336-45 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 58892-336-45 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 58892-336-45 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 58892-336-45 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 58892-336-45 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 58892-336-45 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 58892-336-45 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 58892-336-45 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58892-336-45 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 58892-336-45 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 58892-336-45 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 58892-336-50 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 58892-336-45 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 58892-336-50 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 58892-336-45 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 58892-336-50 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 58892-336-45 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 58892-336-50 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 58892-336-45 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 58892-336-45 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 58892-336-45 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 58892-336-45 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 58892-336-45 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 58892-336-45 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 58892-336-45 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product I Inactivated by FDA 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 58892-336-45 I Inactivated by FDA 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 TiZO2
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 40.7 mg/mL TITANIUM DIOXIDE 85.4 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 15FIX9V2JP 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# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Titanium Dioxide ACTIVE INGREDIENT 15FIX9V2JP SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2 Zinc Oxide ACTIVE INGREDIENT SOI2LOH54Z SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2 Titanium Dioxide ACTIVE MOIETY 15FIX9V2JP SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2 Zinc Oxide ACTIVE MOIETY SOI2LOH54Z SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2 Aluminum Oxide INACTIVE INGREDIENT LMI26O6933 SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2 Cyclomethicone 5 INACTIVE INGREDIENT 0THT5PCI0R SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2 Dimethicone INACTIVE INGREDIENT 92RU3N3Y1O SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA 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 58892-336 TIZO2 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] 4 Current NDC, Legacy NDC, 2 package rows 20241004_43bec652-3f2c-4671-8a0c-c4c4a4bfcc7a.zip 58892-336 SOLAR PROTECTION FORMULA TIZO2 LIGHT SKIN FORMULA SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] 2 Current NDC, Legacy NDC, 2 package rows 20121208_30468afc-9616-4765-b046-12e97a0a7827.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 156 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join OUHOE Sunscreen TITANIUM DIOXIDE Shantou Ouhoe Technology Co., Ltd. 42fcc9ed-083c-6582-e063-6394a90ae9e6 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Sun Cream TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 305cb87e-450f-840a-e063-6294a90a883f 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Bio Sun Stick TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 349a3d72-9969-855d-e063-6394a90a281c 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Cica Cooling Sun Stick TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 305c13af-0843-f478-e063-6394a90a42de 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Quick Sun Stick Protection Bar TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 3578c958-a457-402b-e063-6394a90a7342 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Matte Sun Stick TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 42cfa690-15fe-e5de-e063-6394a90a8e71 2025-11-27 Warnings Exact identifier application number: M020 JAYSUING Moisturiser Sun Stick TITANIUM DIOXIDE Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. 42c307d9-aaa9-30df-e063-6294a90aa114 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Kids Mineral Sunscreen Stick SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 4494bea6-ab1f-aae6-e063-6394a90a184d 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Baby Mineral Sunscreen Stick SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44853202-6873-0bc8-e063-6394a90a05f0 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 43f43c5a-2680-f549-e063-6394a90aade3 2025-11-27 Warnings Exact identifier application number: M020 Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50 TITANIUM DIOXIDE, ZINC OXIDE THG Beauty USA LLC 44952d01-7f38-0a9c-e063-6394a90a2018 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Tropical coco ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44954d7c-2a78-3df4-e063-6294a90ab56f 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Kids Mineral Sunscreen Stick SPF 50 Watermelon and Coco ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 449712ab-5c23-7d50-e063-6394a90ab7fe 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Sun kissed vanilla ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44991f67-9160-ccce-e063-6394a90ada1f 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Sprayer SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 4499bcda-f0ba-878e-e063-6394a90a5fc0 2025-11-27 Warnings Exact identifier application number: M020 EcoZinc Kids Natural Mineral Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 44615ae4-8206-122d-e063-6294a90a0b2c 2025-11-27 Warnings Exact identifier application number: M020 HANCHOBIT Sunscreen TITANIUM DIOXIDE HANCHOYEANBIOTEC Co.,Ltd. 42fd5d3e-4e98-86d7-e063-6294a90a45c2 2025-11-27 Warnings Exact identifier application number: M020 HANCHOBIT Sunscreen TITANIUM DIOXIDE HANCHOYEANBIOTEC Co.,Ltd. 375b60f1-ad33-578a-e063-6294a90a1fc6 2025-11-27 Warnings Exact identifier application number: M020 EcoZinc x DSO Welders 98 percent UVC Protection Sunscreen for Welding ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 386e35de-cd13-f430-e063-6394a90acc84 2025-11-27 Warnings Exact identifier application number: M020 HANCHOBIT Matte Sun Stick TITANIUM DIOXIDE HANCHOYEANBIOTEC Co.,Ltd. 375bacf7-9372-bff7-e063-6294a90ae67c 2025-11-27 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 58892-336-05 58892033605 5 mL in 1 TUBE (58892-336-05) 5 ml 2015-04-27 No No Current 58892-336-15 58892033615 1.5 mL in 1 PACKET (58892-336-15) 1.5 ml 2015-04-27 No No Current 58892-336-45 58892033645 44.4 mL in 1 TUBE 44.4 ml Historical 58892-336-50 58892033650 1 TUBE in 1 CARTON (58892-336-50) / 50 mL in 1 TUBE 1 tube 2015-04-27 0000-00-00 No No Current