FDA.reportPublic FDA data

TiZO2 - Fallien Cosmeceuticals Ltd. | Fragrance Manufacturing Inc. | Custom Analytics LLC

Manufacturer
Fallien Cosmeceuticals Ltd. | Fragrance Manufacturing Inc. | Custom Analytics LLC
Effective date
2026-04-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:55:23

Label at a glance#

ProductTiZO2
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure9 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. If used as directed with other sun protection measures (see “Directions”), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS SECTION

For external use only. Do not use on broken or damaged skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.

INACTIVE INGREDIENT SECTION

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

OTHER SAFETY INFORMATION

PA++++

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130358892336050GTIN-13: 0358892336050
EAN-13: 0358892336050
GTIN-12: 358892336050
UPC-A: 358892336050
GTIN storage (14 digits): 00358892336050		TIZO2 5g.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-336-05TiZO25 mL in 1 TUBECREAM51

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58892-33658892-336-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509cad98-0321-2a0a-e063-6294a90a6ea92026-04-29WarningsExact identifier
ndc (product): 58892-336
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509d7206-0cc1-c997-e063-6294a90a89e02026-04-29WarningsExact identifier
ndc (package): 58892-336-05
ndc (product): 58892-336
ndc11 (package): 58892033605
spl id: 509d7206-0cc2-c997-e063-6294a90a89e0
spl set id: 509d7206-0cc1-c997-e063-6294a90a89e0
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD43bec652-3f2c-4671-8a0c-c4c4a4bfcc7a2024-10-01WarningsExact identifier
ndc (product): 58892-336
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD.30468afc-9616-4765-b046-12e97a0a78272010-12-20WarningsExact identifier
ndc (product): 58892-336

Reported adverse events (FAERS/openFDA)#

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