FDA.reportPublic FDA data

TiZO3

Manufacturer
Fallien Cosmeceuticals Ltd. | Custom Analytics LLC | Fragrance Manufacturing Inc.
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:52:33

Label at a glance#

ProductTiZO3
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 8%

Zinc Oxide 3.8%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

WARNINGS SECTION

For external use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure.

INACTIVE INGREDIENT SECTION

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130358892326051GTIN-13: 0358892326051
EAN-13: 0358892326051
GTIN-12: 358892326051
UPC-A: 358892326051
GTIN storage (14 digits): 00358892326051		TiZO3_5g.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-326-05TiZO35 mL in 1 TUBECREAM51

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58892-32658892-326-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYCLOPENTASILOXANE0THT5PCI0RIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ALUMINALMI26O6933IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
LAURYL PEG/PPG-18/18 METHICONEZJ5S27D9NXIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
CI 77492EX438O2MRTIACT
CI 77499XM0M87F357IACT
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
CI 774911K09F3G675IACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD4e7bdec2-abcc-0267-e063-6394a90ae47a2026-04-02WarningsExact identifier
ndc (product): 58892-326
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.468d6476-127a-e9f0-e063-6294a90a3df92025-12-22WarningsExact identifier
ndc (package): 58892-326-05
ndc (product): 58892-326
ndc11 (package): 58892032605
spl id: 468d6476-127b-e9f0-e063-6294a90a3df9
spl set id: 468d6476-127a-e9f0-e063-6294a90a3df9

Reported adverse events (FAERS/openFDA)#

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