FDA.reportPublic FDA data

TiZO Photoceutical Environmental Skin Protectant

Manufacturer
Fallien Cosmeceuticals, LTD | Custom Analytics LLC | Fragrance Manufacturing Inc. (FMI)
Effective date
2024-11-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:37:28

Label at a glance#

ProductTiZO Photoceutical Environmental Skin Protectant
Active ingredientDIMETHICONE
Label structure9 sections

Indications and uses

Temporarily protects and helps relieve chapped or cracked skin. Helps protect from the drying effects of wind and cold weather.

Dosage and administration

Gently cleanse and dry affected area Apply liberally to affected area as needed

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 3%

Purpose:

OTC - PURPOSE SECTION

Skin Protectant

Uses:

INDICATIONS & USAGE SECTION

  • Temporarily protects and helps relieve chapped or cracked skin.
  • Helps protect from the drying effects of wind and cold weather.

Warnings:

WARNINGS SECTION

  • For external use only.

Do not use on:

OTC - DO NOT USE SECTION

  • deep puncture wounds
  • animal bites
  • serious burns

When using this product:

OTC - WHEN USING SECTION

  • Do not get into eyes

Stop use and ask doctor if:

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach out children.

SPL UNCLASSIFIED SECTION

If swallowed, get medical help or contact a poison control center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Gently cleanse and dry affected area
  • Apply liberally to affected area as needed

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Bisabolol, Caprylhydroxamic Acid, Caprylyl Glycol, Ceramide 3, Copper PCA Methylsilanol, Cydohexasiloxane, Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Glycerin, Isohexadecane, Isononyl Isononanoate, Lauryl PEG/PPG-18/18 Hydrogen Dimethicone, Propyl Gallate, Polysorbate 20, Saccharomyces/ Copper Ferment, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, Vinyl Dimethicone/Hydrogen Dimethicone Silsesquioxane Crosspolymer, Water

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

Principal Display Panel – Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENVIRONMENTAL

SKIN PROTECTANT

TIZO®

PHOTOCEUTICAL®

Especially effective against
environmental damage

Dimethicone 3%

Copper Peptides

Bisabolol

featuring

SKIN FIRM TECHNOLOGY®

1 Fl. Oz./29 ml

Principal Display Panel – Carton Label
Principal Display Panel – Carton Label

Principal Display Panel – Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TIZO®

PHOTOCEUTICAL®

ENVIRONMENTAL

SKIN PROTECTANT

Dimethicone 3%

Copper Peptides

Bisabolol

featuring

SKIN FIRM TECHNOLOGY®

1 Fl. Oz./29 ml

Principal Display Panel – Bottle Label
Principal Display Panel – Bottle Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-105-30TiZO Photoceutical Environmental Skin Protectant1 in 1 CARTONGEL13
58892-105-30TiZO Photoceutical Environmental Skin Protectant29 mL in 1 BOTTLEGEL293

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-105TIZO PHOTOCEUTICAL ENVIRONMENTAL SKIN PROTECTANT (DIMETHICONE) GEL [FALLIEN COSMECEUTICALS, LTD]3Current NDC, Legacy NDC, 2 package rows20241116_84a3299d-9b98-492e-a83f-ebd72ec58f8d.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58892-10558892-105-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-BISABOLOL, (+/-)-36HQN158VCIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CERAMIDE NP4370DF050BIACT
COPPER PIDOLATE497G7G1SL1IACT
METHYLSILANOL PCA837430510VIACT
CYCLOMETHICONE 6XHK3U310BAIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
GLYCERINPDC6A3C0OXIACT
ISOHEXADECANE918X1OUF1EIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
LAURYL PEG/PPG-18/18 METHICONEZJ5S27D9NXIACT
PROPYL GALLATE8D4SNN7V92IACT
POLYSORBATE 207T1F30V5YHIACT
SACCHAROMYCES CEREVISIAE978D8U419HIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OACTIB

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
TiZO Photoceutical Environmental Skin ProtectantDIMETHICONEFallien Cosmeceuticals, LTD84a3299d-9b98-492e-a83f-ebd72ec58f8d2024-11-14WarningsExact identifier
ndc (package): 58892-105-30
ndc (product): 58892-105
ndc11 (package): 58892010530
spl id: 26e5b5e4-fbb5-2d08-e063-6394a90a95d5
spl set id: 84a3299d-9b98-492e-a83f-ebd72ec58f8d

Reported adverse events (FAERS/openFDA)#

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