TiZO Mineral Sun Defense SPF 50

Manufacturer
Fallien Cosmeceuticals Ltd. | Fragrance Manufacturing Inc. | Custom Analytics LLC
Effective date
2025-01-31
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 ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 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:

WARNINGS SECTION

For external use only.

Warning and Directions:

DOSAGE & ADMINISTRATION SECTION

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

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

Warning:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-128-05TiZO Mineral Sun Defense SPF 505 g in 1 TUBECREAM51

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_2d0766a1-4091-e84a-e063-6394a90a004a.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
58892-12858892-128-05

Ingredients#

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

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

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 (package): 58892-128-05
ndc (product): 58892-128
ndc11 (package): 58892012805
spl id: 2d0766a1-4092-e84a-e063-6394a90a004a
spl set id: 2d0766a1-4091-e84a-e063-6394a90a004a
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2cc8f7ef-eda3-fe71-e063-6394a90a6a9a2025-01-28WarningsExact identifier
ndc (product): 58892-128
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.