FDA.reportPublic FDA data

TiZO Eye Renewal SPF 20 (Non-Tinted)

Manufacturer
Fallien Cosmeceuticals, LTD | Fragrance Manufacturing Inc. | Custom Analytics LLC
Effective date
2025-02-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:54:47

Label at a glance#

ProductTiZO Eye Renewal SPF 20 (Non-Tinted)
Active ingredientZINC OXIDE
Label structure8 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 9%

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Directions:

INDICATIONS & USAGE SECTION

Apply liberally 15 minutes before sun exposure.

Warning:

WARNINGS SECTION

For external use only. Keep out of the reach of children.

Warning and Directions:

DOSAGE & ADMINISTRATION SECTION

For external use only. Keep out of the reach of children. Apply liberally 15 minutes before sun exposure.

INACTIVE INGREDIENT SECTION

Butylene Glycol, Caffeine, Carbomer, Caprylhydroxamic Acid, Caprylyl Glycol, Corallina Officinalis Extract, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Glycerin, Hydrogen Dimethicone, Isododecane, Isohexadecane, Lauryl PEG/PPG-18/18 Methicone, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, PEG-10 Dimethicone, Polysorbate 20, Saccharomyces/Selenium Ferment, Sambucus Nigra Flower Extract, Siloxanetriol Alginate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Undaria Pinnatifida Extract, 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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-113-05TiZO Eye Renewal SPF 20 (Non-Tinted)1.5 g in 1 PACKETCREAM1.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-113TIZO EYE RENEWAL SPF 20 (NON-TINTED) (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]1Current NDC, Legacy NDC, 1 package rows20250212_2d40099a-2cfa-1d99-e063-6394a90a36a6.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58892-11358892-113-05

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
ZINC OXIDESOI2LOH54ZACTIB
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
SAMBUCUS NIGRA FLOWER07V4DX094TIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
POLYSORBATE 207T1F30V5YHIACT
SACCHAROMYCES CEREVISIAE978D8U419HIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PALMITOYL TETRAPEPTIDE-7Q41S464P1RIACT
GLYCERINPDC6A3C0OXIACT
ISOHEXADECANE918X1OUF1EIACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
SILANETRIOLE52D0J3TS5IACT
LAURYL PEG/PPG-18/18 METHICONEZJ5S27D9NXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CORALLINA OFFICINALIS4004498D06IACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
WATER059QF0KO0RIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
ISODODECANEA8289P68Y2IACT
CYCLOHEXASILOXANEXHK3U310BAIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
CARBOMER0A5MM307FCIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CAFFEINE3G6A5W338EIACT
UNDARIA PINNATIFIDAICV1OK7M1SIACT

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
TiZO Eye Renewal SPF 20 (Non-Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD2d40099a-2cfa-1d99-e063-6394a90a36a62025-02-03WarningsExact identifier
ndc (package): 58892-113-05
ndc (product): 58892-113
ndc11 (package): 58892011305
spl id: 2d40099a-2cfb-1d99-e063-6394a90a36a6
spl set id: 2d40099a-2cfa-1d99-e063-6394a90a36a6
TiZO Eye Renewal SPF 20 (Non-Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD33f8760c-2953-44a6-9239-424fdb97a5b32024-10-18WarningsExact identifier
ndc (product): 58892-113

Reported adverse events (FAERS/openFDA)#

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