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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct58892-326IInactivated by FDA2026-10-12
excluded productproduct58892-326IInactivated by FDA2026-10-12
excluded packagepackage58892-32658892-326-20IInactivated by FDA2026-10-12
excluded packagepackage58892-32658892-326-50IInactivated by FDA2026-10-12

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage58892-326-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58892-326-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58892-326-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58892-326-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58892-326-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58892-326-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58892-326-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58892-326-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58892-326-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58892-326-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58892-326-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58892-326-50557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58892-326-20557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage58892-326-508af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage58892-326-208af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage58892-326-50834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage58892-326-20834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage58892-326-501332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage58892-326-201332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage58892-326-20fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage58892-326-2086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage58892-326-20bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage58892-326-208dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage58892-326-20e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage58892-326-209bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage58892-326-20110d247fa046…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
IngredientStrength
TITANIUM DIOXIDE85.4 mg/mL
ZINC OXIDE40.7 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
468d6476-127a-e9f0-e063-6294a90a3df9Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58892-326-502024-10-02C16284748780-11030e365-68ea-111a-e063-dadaa90a10e2DRUG FACTS
58892-326-502024-01-30C16284748780-11030e365-68ea-111a-e063-dadaa90a10e2DRUG FACTS
58892-326-202019-11-27C16284748780-19855d018-e65d-cd31-e053-dbdaa90ab51aa5d22c0f-c55b-4344-ba7f-1b40d3b7c5a3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-326-50TiZO344.4 mL in 1 TUBECREAM44.44
58892-326-50TiZO31 in 1 CARTONCREAM14
58892-326-20Solar Protection Formula TiZO3 Sunscreen44.4 mL in 1 TUBECREAM44.42
58892-326-20Solar Protection Formula TiZO3 Sunscreen1 in 1 CARTONCREAM12
58892-326-05TiZO35 mL in 1 TUBECREAM51
58892-326-85TiZO385 mL in 1 BOTTLE, PUMPCREAM851

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-326TIZO3 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]4Current NDC, Legacy NDC, 2 package rows20241004_2e53defe-98a3-4689-8763-35d76b5701c3.zip
58892-326SOLAR PROTECTION FORMULA TIZO3 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]2Current NDC, Legacy NDC, 2 package rows20121208_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 10 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DARKZINC OXIDEYounique, LLC2173666b-6c72-449d-9f40-098ea174f3e12026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DARK DEEPZINC OXIDEYounique, LLC360ceb90-bec6-4fec-820a-a4d65008b8722026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DEEPZINC OXIDEYounique, LLC86c33a9e-9132-4377-8688-41e5844de62c2026-07-23WarningsExact identifier
application number: M020
MENOKIN 30 SECONDS GLOW AND CLEAR Gel SUNSCREEN MOISTUREAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEForest Avenue Co., Ltd.edbfcf21-96c6-4519-8b08-f9b5ada7d1d72026-07-23WarningsExact identifier
application number: M020
LBEL SOLUTIONS PRO NUDE SKIN BASE SERUM TINT COBERTURA ANTIMANCHAS FPS 15 ANTI DARK SPOT COVERAGE SERUM TINT FOUNDATION SPF 15 CHAMPAGNE 170-NOCTINOXATE, ZINC OXIDEBEL STAR S.A.574c96e9-77a2-778f-e063-6394a90a0aae2026-07-23WarningsExact identifier
application number: M020
SKINSUIT LIP SPF 30ZINC OXIDESkin Authority LLCcb24d714-f6cd-4518-b146-627cfe6c2ccd2026-07-23WarningsExact identifier
application number: M020
SKINSUIT FACE SPF 50ZINC OXIDESkin Authority LLC389fc528-fda5-485a-ab37-f99fcf3ed0b32026-07-23WarningsExact identifier
application number: M020
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
application number: M020
Native Daily Face Mineral Sunscreen Broad Spectrum SPF 30 Coconut and PineappleZINC OXIDEThe Procter & Gamble Manufacturing Company3519e5bc-8c07-0617-e063-6394a90a65ae2026-07-22WarningsExact identifier
application number: M020
Tula Skincare Radiant Skin Brightening Serum Skin Tint Broad Spectrum SPF 30 01 Very Light NeutralAVOBENZONE, AND OCTISALATEThe Procter & Gamble Manufacturing Company366144c4-ec80-e435-e063-6394a90aba542026-07-22WarningsExact identifier
application number: M020
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
application number: M020
YSE Beauty Instant Glow TrioAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMSS Beauty LLC6742e089-565a-40bc-8ffa-ec06e79860282026-07-21WarningsExact identifier
application number: M020
YSE Beauty The Roadies Packable AM RoutineAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMSS Beauty LLCb0844331-d277-4cfb-957a-d8f9498836842026-07-21WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Day Cream SPF 30AVOBENZONE,OCTISALATE,OCTOCRYLENEBCM Cosmetique SAS328f96bc-fb68-33dc-e063-6294a90aecfa2026-07-21WarningsExact identifier
application number: M020
Sunscreen In the Raw SPF 50ZINC OXIDEBiomin LLC625523f0-366f-4148-b927-d726b7d1b9f42026-07-20WarningsExact identifier
application number: M020
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
application number: M020
Native Mineral Suncare Broad Spectrum SPF 30 Coconut and PineappleZINC OXIDEThe Procter & Gamble Manufacturing Company3a87ddee-241d-f972-e063-6294a90a7e892026-07-20WarningsExact identifier
application number: M020
Native Mineral Suncare Daily Face Broad Spectrum SPF 30 UnscentedZINC OXIDEThe Procter & Gamble Manufacturing Company3a893b13-e7f5-c5b1-e063-6394a90a42532026-07-20WarningsExact identifier
application number: M020
Omnilux Mineral Facial SunscreenZINC OXIDEThe Lotus Global Group, Inc, dba GlobalMed Technologies5710c84b-9d6b-da4d-e063-6394a90a07372026-07-20WarningsExact identifier
application number: M020
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58892-326-05588920326055 mL in 1 TUBE (58892-326-05) 5 ml2015-05-10NoNoCurrent
58892-326-205889203262044.4 mL in 1 TUBE44.4 mlHistorical
58892-326-50588920326501 TUBE in 1 CARTON (58892-326-50) > 44.4 mL in 1 TUBE1 tube2015-03-250000-00-00NoNoCurrent
58892-326-855889203268585 mL in 1 BOTTLE, PUMP (58892-326-85) 85 ml2007-05-21NoNoCurrent