FDA.reportPublic FDA data

TiZO Mineral Sun Defense SPF 50

Manufacturer
Fallien Cosmeceuticals Ltd. | Fragrance Manufacturing Inc. | Custom Analytics LLC
Effective date
2025-01-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:54:46

Label at a glance#

ProductTiZO Mineral Sun Defense SPF 50
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure7 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure.

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 10% Zinc Oxide 3%

(Purpose)

OTC - PURPOSE SECTION

Sunscreen

Directions:

INDICATIONS & USAGE SECTION

Apply liberally 15 minutes before sun exposure.

Warning and Directions:

DOSAGE & ADMINISTRATION SECTION

For external use only. Apply liberally 15 minutes before sun exposure.

Warning:

WARNINGS SECTION

For external use only.

INACTIVE INGREDIENT SECTION

Bismuth Oxychloride, Capric/Caprylic Triglyceride, Caprylhydroxamic Acid, Caprylyl Glycol, Ceteareth-20, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Iron Oxides, Isododecane, Isohexadecane, Melissa Officinalis (Balm Mint) Extract, Mica, Microcrystalline Wax, Octyldodecyl Neopentanoate, PEG-30 Dipolyhydroxystearate, Sodium Chloride, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Tocopherol, Triethanolamine, Triethoxycaprylylsilane, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-128-15TiZO Mineral Sun Defense SPF 501.5 g in 1 PACKETCREAM1.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-128TIZO MINERAL SUN DEFENSE SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS LTD.]1Current NDC, 1 package rows20250212_2cc8f7ef-eda3-fe71-e063-6394a90a6a9a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58892-12858892-128-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
BISMUTH OXYCHLORIDE4ZR792I587IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
ISOHEXADECANE918X1OUF1EIACT
ISODODECANEA8289P68Y2IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETEARETH-20YRC528SWUYIACT
ETHYLHEXYL HYDROXYSTEARATE BENZOATE3W8F25684BIACT
IRON OXIDES1K09F3G675IACT
MICAV8A1AW0880IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
TOCOPHEROLR0ZB2556P8IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ZINC OXIDESOI2LOH54ZACTIB
SODIUM CHLORIDE451W47IQ8XIACT
TRIETHANOLAMINE9O3K93S3TKIACT
MELISSA OFFICINALIS WHOLEYF70189L0NIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
DIMETHICONE92RU3N3Y1OIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2d0766a1-4091-e84a-e063-6394a90a004a2025-01-31WarningsExact identifier
ndc (product): 58892-128
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2cc8f7ef-eda3-fe71-e063-6394a90a6a9a2025-01-28WarningsExact identifier
ndc (package): 58892-128-15
ndc (product): 58892-128
ndc11 (package): 58892012815
spl id: 2cc8f7ef-eda4-fe71-e063-6394a90a6a9a
spl set id: 2cc8f7ef-eda3-fe71-e063-6394a90a6a9a
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.e17a8c35-2d49-4c99-b154-ea673c14753e2024-10-25WarningsExact identifier
ndc (product): 58892-128

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.