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 28 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ILIA SUPER SERUM SKIN TINT (ST11 MATIRA) ZINC OXIDE Ilia, Inc. b595b5f0-dd3d-79ef-e053-2a95a90ad9fb 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST10 PORTO FERRO) ZINC OXIDE Ilia, Inc. b595a378-3285-bea2-e053-2995a90aedbf 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST15 PORTO COVO) ZINC OXIDE Ilia, Inc. b595db16-796c-726f-e053-2995a90ab783 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST2 TULUM) ZINC OXIDE Ilia, Inc. b5939cc9-4eab-5f73-e053-2995a90a7a7b 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST8 SHELA) ZINC OXIDE Ilia, Inc. b5956413-af6b-11bd-e053-2a95a90a9047 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST9 PALOMA) ZINC OXIDE Ilia, Inc. b5959358-0d93-aa37-e053-2995a90acdae 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST1 RENDEZVOUS) ZINC OXIDE Ilia, Inc. b592225c-904e-350a-e053-2a95a90adc2b 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST7 DIAZ) ZINC OXIDE Ilia, Inc. b5954732-66d7-53db-e053-2995a90a2a3b 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST4 FORMOSA) ZINC OXIDE Ilia, Inc. b594d426-a79e-19e9-e053-2995a90aa665 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST3 BALOS) ZINC OXIDE Ilia, Inc. b594bc81-d164-bda7-e053-2995a90a69ad 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST18 MALI) ZINC OXIDE Ilia, Inc. b59608e6-a407-75dc-e053-2995a90a25cf 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST19 LOVINA) ZINC OXIDE Ilia, Inc. b9805c9c-0513-2386-e053-2995a90a2185 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST5 BOM BOM) ZINC OXIDE Ilia, Inc. b594f910-f1bc-2bcf-e053-2995a90aebee 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST17.5 PERISSA) ZINC OXIDE Ilia, Inc. b9805059-583d-e3da-e053-2a95a90a4f65 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST14.5 HONOPU) ZINC OXIDE Ilia, Inc. b9803596-c090-463f-e053-2a95a90a0234 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST6.5 KAI) ZINC OXIDE Ilia, Inc. b97f5589-069d-7e93-e053-2a95a90a19a9 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST12.75 PAPAKOLEA) ZINC OXIDE Ilia, Inc. b97fa903-4a0f-064e-e053-2a95a90a1c61 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST16.5 JARDIN) ZINC OXIDE Ilia, Inc. b980155b-98f1-6460-e053-2a95a90a58a2 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST13.5 RIALTO) ZINC OXIDE Ilia, Inc. b97fadb3-fa6e-26b0-e053-2a95a90abfd5 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST9.5 BAIKAL) ZINC OXIDE Ilia, Inc. b97f7fe9-c06e-7c11-e053-2a95a90a6a6d 2026-05-21 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