FDA.reportPublic FDA data

PROCEUTICALS PRIVATE LABEL by TiZO eye repair non-tinted mineral sunscreen

Manufacturer
Fallien Cosmeceuticals, LTD | Custom Analytics LLC | Fragrance Manufacturing Inc. (FMI)
Effective date
2024-09-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:22:12

Label at a glance#

ProductPROCEUTICALS PRIVATE LABEL by TiZO eye repair non-tinted mineral sunscreen
Active ingredientZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT: Zinc Oxide 9%

OTC - PURPOSE SECTION

PURPOSE:Sunscreen

INDICATIONS & USAGE SECTION

DIRECTIONS: • 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 am - 2 pm • Wear long-sleeved shirts, pants, hats,
and sunglasses

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: 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

OTHER SAFETY INFORMATION

OTHER INFORMATION: • Protect this product from excessive
heat and direct sun

WARNINGS SECTION

WARNINGS: For external use only. Do not use on damaged
or broken 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 the reach of
children.

DOSAGE & ADMINISTRATION 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.

Apply liberally 15 minutes before sun exposure.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel – 15 g Bottle Label

Proceuticals

PRIVATE LABEL by TiZO

eye repair non-tinted
mineral sunscreen

broad spectrum spf 20 with
gentle zinc oxide, peptides
& botanical blend

net wt. 0.5 oz. / 15 g

Graphic-Untitled

Reference 58892-236-05 Eye Cream proceuticalsReference 58892-236-05 Eye Cream proceuticals

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
58892-236-05PROCEUTICALS PRIVATE LABEL by TiZO eye repair non-tinted mineral sunscreen15 g in 1 BOTTLE, PUMPCREAM152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-236PROCEUTICALS PRIVATE LABEL BY TIZO EYE REPAIR NON-TINTED MINERAL SUNSCREEN (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]2Current NDC, 1 package rows20240929_231af290-99ee-e94d-e063-6394a90a0bef.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
58892-23658892-236-05

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
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ZINC OXIDESOI2LOH54ZACTIB
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CORALLINA OFFICINALIS4004498D06IACT
POLYSORBATE 207T1F30V5YHIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
CYCLOMETHICONE 6XHK3U310BAIACT
CYCLOMETHICONE 50THT5PCI0RIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
LAURYL PEG/PPG-18/18 METHICONEZJ5S27D9NXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SILANETRIOLE52D0J3TS5IACT
GLYCERINPDC6A3C0OXIACT
ISOHEXADECANE918X1OUF1EIACT
UNDARIA PINNATIFIDAICV1OK7M1SIACT
SACCHAROMYCES CEREVISIAE978D8U419HIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CAFFEINE3G6A5W338EIACT
ISODODECANEA8289P68Y2IACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
WATER059QF0KO0RIACT
PALMITOYL TETRAPEPTIDE-7Q41S464P1RIACT
SAMBUCUS NIGRA FLOWER07V4DX094TIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROCEUTICALS PRIVATE LABEL by TiZO eye repair non-tinted mineral sunscreenZINC OXIDEFallien Cosmeceuticals, LTD231af290-99ee-e94d-e063-6394a90a0bef2024-09-27WarningsExact identifier
ndc (package): 58892-236-05
ndc (product): 58892-236
ndc11 (package): 58892023605
spl id: 231aea5b-aaee-abdd-e063-6394a90accb2
spl set id: 231af290-99ee-e94d-e063-6394a90a0bef

Reported adverse events (FAERS/openFDA)#

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