FDA.reportPublic FDA data

TiZO Ultra Zinc SPF 40 (Tinted)

Manufacturer
Fallien Cosmeceuticals, LTD | Fragrance Manufacturing Inc. | Custom Analytics LLC
Effective date
2025-01-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:54:46

Label at a glance#

ProductTiZO Ultra Zinc SPF 40 (Tinted)
Active ingredientZINC OXIDE
Label structure8 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure.

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Directions:

INDICATIONS & USAGE SECTION

Apply liberally 15 minutes before sun exposure.

Warnings:

WARNINGS SECTION

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

Warnings and Directions:

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

Bismuth Oxychloride, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Iron Oxides, Mica, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, 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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-319-15TiZO Ultra Zinc SPF 40 (Tinted)1.5 g in 1 PACKETCREAM1.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-319TIZO ULTRA ZINC SPF 40 (TINTED) (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]1Current NDC, Legacy NDC, 1 package rows20250212_2d0856cf-d3da-5a77-e063-6294a90ad5b4.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58892-31958892-319-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
IRON OXIDES1K09F3G675IACT
TRIETHANOLAMINE9O3K93S3TKIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
ZINC OXIDESOI2LOH54ZACTIB
BISMUTH OXYCHLORIDE4ZR792I587IACT
CAPRYLYL GLYCOL00YIU5438UIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
STEARYL DIMETHICONE (400 MPA.S AT 50C)R327X197HYIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
POLYSORBATE 207T1F30V5YHIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
MICAV8A1AW0880IACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
WATER059QF0KO0RIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)8INO2K35FAIACT
SODIUM CHLORIDE451W47IQ8XIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TiZO Ultra Zinc SPF 40 (Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD.2d3faa43-0d78-58de-e063-6294a90a0b172025-02-03WarningsExact identifier
ndc (product): 58892-319
TiZO Ultra Zinc SPF 40 (Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD2d0856cf-d3da-5a77-e063-6294a90ad5b42025-01-31WarningsExact identifier
ndc (package): 58892-319-15
ndc (product): 58892-319
ndc11 (package): 58892031915
spl id: 2d0856cf-d3db-5a77-e063-6294a90ad5b4
spl set id: 2d0856cf-d3da-5a77-e063-6294a90ad5b4
TiZO Ultra Zinc SPF 40 (Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD36efd48b-910e-4b61-9519-a6d5c7e9a7c32024-10-29WarningsExact identifier
ndc (product): 58892-319

Reported adverse events (FAERS/openFDA)#

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