Home NDC 58892-326-85 TiZO3
Product NDC 58892-326
Requested package NDC 58892-326-85
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 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 39 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HYDRA SPF 34 HOMOSALATE, OCTYL SALICYLATE, AVOBENZONE Drmtlgy, LLC 31e41ed5-8498-4e2d-928a-c15ca99775e4 2026-04-21 Warnings Exact identifier application number: M020 FORGESKIN MINERAL TALLOW SUNSCREEN GUANGZHOU KANGLIXIN BIOTECHNOLOGY CO.,LTD 4fe913f4-b0be-dc53-e063-6294a90a363c 2026-04-20 Warnings Exact identifier application number: M020 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM AVOBENZONE, HOMOSALATE, OCTISALATE SEORIN COMPANY Co., Ltd. 228dcd68-aaba-0451-e063-6394a90a8ad0 2026-04-20 Warnings Exact identifier application number: M020 Biore Aqua Rich UV OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE KAO USA f900db18-5fe2-1d74-e053-6394a90a3ca2 2026-04-20 Warnings Exact identifier application number: M020 Biore UV Aqua Rich OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE KAO USA 2bc23bb5-86bb-7915-e063-6394a90a9d72 2026-04-20 Warnings Exact identifier application number: M020 ETUDE SunPrise Mild Airy Finish Sunstick AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE ETUDE CORPORATION 25abc744-5b62-acb4-e063-6394a90af110 2026-04-19 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7c399-b05e-2545-e053-2995a90ac611 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7c399-b060-2545-e053-2995a90ac611 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7d9f4-986f-70f7-e053-2a95a90a4f8a 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c81845-afcb-18ac-e053-2a95a90abdbe 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c83245-a40c-8f05-e053-2a95a90a0521 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c84047-fd3b-ea66-e053-2a95a90ae9aa 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c623aa-3846-b7f4-e053-2995a90aecb5 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c585ff-88de-e29c-e053-2a95a90af4d4 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c852de-4c36-6d93-e053-2995a90aff61 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c86288-bb22-03b1-e053-2995a90a3161 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c8742f-1060-48bc-e053-2995a90a31c2 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c4eedc-12a0-6418-e053-2a95a90a55e7 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c8849a-6624-6987-e053-2a95a90a4546 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c8ac70-a8c8-2f07-e053-2a95a90a3d01 2026-04-18 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58892-326-85 58892032685 85 mL in 1 BOTTLE, PUMP (58892-326-85) 85 ml 2007-05-21 No No Current