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 331 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30 OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE MAX HUBER RESEARCH LAB INC ecc942c7-5495-43b1-9ffa-d38be7891152 2023-10-30 Warnings Exact identifier application number: M020 Babo Botanicals Sheer Zinc Mineral Sunscreen SPF30 ZINC OXIDE Babo Botanicals, Inc. 08f0f32e-4b19-7a62-e063-6394a90af1b1 2023-10-30 Warnings Exact identifier application number: M020 BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC e5e5777c-2f67-14ed-e053-2a95a90a58a5 2023-10-30 Warnings Exact identifier application number: M020 CoreTex Sun X SPF 30 New AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CoreTex Products Inc 08fb4748-d22d-35af-e063-6394a90a0827 2023-10-30 Warnings Exact identifier application number: M020 LIVE TINTED Hueguard 3-in-1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30 ZINC OXIDE Live Tinted, Inc. d177b085-2bbd-49c1-b02b-a7b8d8ee0468 2023-10-28 Warnings Exact identifier application number: M020 Live Tinted Hueguard 3-in1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30 ZINC OXIDE Live Tinted, Inc. cfceaf45-bab5-6858-e053-2a95a90a6be1 2023-10-28 Warnings Exact identifier application number: M020 LIVE TINTED Hueguard Invisible Sunscreen Stick Broad Spectrum SPF 50 Water Resistant 80 Mins HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Live Tinted, Inc. 8e4d7c84-5acb-4857-860d-bf6837e4901e 2023-10-28 Warnings Exact identifier application number: M020 LIVE TINTED Hueguard 3-in-1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30 ZINC OXIDE Live Tinted, Inc. 7bceeb0e-b557-438c-88ac-0148f6eb1b4d 2023-10-28 Warnings Exact identifier application number: M020 Green Defense daily mineral sunscreen Broad Spectrum SPF 30 ZINC OXIDE Farmacy Beauty LLC d1ae2696-fd1b-4422-a8e0-5209aeeb97eb 2023-10-28 Warnings Exact identifier application number: M020 LIVE TINTED Glow-up Hyperpigmentation Essentials ZINC OXIDE Live Tinted, Inc. ef06c1eb-6ce3-4b1b-8a7d-3e29ae172844 2023-10-28 Warnings Exact identifier application number: M020 SPF Elio Drops 30 Sheer ZINC OXIDE Allure Labs Inc 08c9fc56-7d4f-ebc5-e063-6294a90a5317 2023-10-28 Warnings Exact identifier application number: M020 SPF Elio Drops 30 Glow ZINC OXIDE Allure Labs Inc 08cbf8d6-8c27-1567-e063-6394a90a932e 2023-10-28 Warnings Exact identifier application number: M020 RESILIENCE MULTI-EFFECT TRI-PEPTIDE FACE AND NECK CREME BROAD SPECTRUM SPF 15 dry skin AVOBENZONE, OCTISALATE, AND OCTOCRYLENE ESTEE LAUDER INC d1ca8372-28a0-41e1-b92a-913fc09f7156 2023-10-27 Warnings Exact identifier application number: M020 Vivier Sheer SPF 30 Mineral TITANIUM DIOXIDE, ZINC OXIDE Vivier Pharma, Inc. 1be5ee36-3566-495c-aae2-4d0d7fc210ed 2023-10-27 Warnings Exact identifier application number: M020 Vivier Sheer SPF 45 ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE Vivier Pharma, Inc. c057138a-1111-4e7c-b94d-2ccd6bc3963c 2023-10-27 Warnings Exact identifier application number: M020 360 by QUR Spanish lime lip balm OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Qur, Inc bedb3347-7498-3d7a-e053-2995a90a4b12 2023-10-26 Warnings Exact identifier application number: M020 360 by QUR Vanilla lace lip balm OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Qur, Inc bedb4c53-adaa-3a8a-e053-2a95a90ae93a 2023-10-26 Warnings Exact identifier application number: M020 360 by QUR Watercress mint lip balm OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Qur, Inc bedb7413-c074-a2d7-e053-2a95a90ac5cb 2023-10-26 Warnings Exact identifier application number: M020 PRIDEFUL SPF 15 LIP BALM-cherry vanilla HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE PRIDEFUL LLC c827c6b4-c6d7-4585-b615-419db9520e7c 2023-10-26 Warnings Exact identifier application number: M020 PRIDEFUL SPF 15 LIP BALM-citrus HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE PRIDEFUL LLC 2f20ee7e-3897-4263-b965-5155d89bfb5e 2023-10-26 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