FDA.reportPublic FDA data

TiZO Photoceutical AM Replenish Non-Tinted

Manufacturer
Fallien Cosmeceuticals, LTD | Fragrance Manufacturing Inc. | Custom Analytics LLC
Effective date
2025-01-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:54:46

Label at a glance#

ProductTiZO Photoceutical AM Replenish Non-Tinted
Active ingredientZINC OXIDE
Label structure8 sections

Dosage and administration

Apply liberally 15 minutes before sun expsure.

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 16%

(Purpose)

OTC - PURPOSE SECTION

Sunscreen

Directions:

INDICATIONS & USAGE SECTION

Apply liberally 15 minutes before sun expsure.

Warning:

WARNINGS SECTION

For external use only.

Warning and Directions:

DOSAGE & ADMINISTRATION SECTION

For external use only. Apply liberally 15 minutes before sun exposure.

INACTIVE INGREDIENT SECTION

Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydrogen Dimethicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

Warning:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Kepp 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
58892-107-05TiZO Photoceutical AM Replenish Non-Tinted5 g in 1 TUBECREAM51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-107TIZO PHOTOCEUTICAL AM REPLENISH NON-TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]1Current NDC, Legacy NDC, 1 package rows20250212_2cc62961-dcef-d7db-e063-6394a90a9ebd.zip

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
58892-10758892-107-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
CERAMIDE 34370DF050BIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
DIMETHICONE92RU3N3Y1OIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ZINC OXIDESOI2LOH54ZACTIB
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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TiZO Photoceutical AM Replenish Non-TintedZINC OXIDEFallien Cosmeceuticals, LTD2cc62961-dcef-d7db-e063-6394a90a9ebd2025-01-28WarningsExact identifier
ndc (package): 58892-107-05
ndc (product): 58892-107
ndc11 (package): 58892010705
spl id: 2cc62961-dcf0-d7db-e063-6394a90a9ebd
spl set id: 2cc62961-dcef-d7db-e063-6394a90a9ebd
TiZO Photoceutical AM Replenish Non-TintedZINC OXIDEFallien Cosmeceuticals, LTD2cb77125-ff77-2060-e063-6294a90ab69f2025-01-27WarningsExact identifier
ndc (product): 58892-107
TiZO Photoceutical AM Replenish Non-TintedZINC OXIDEFallien Cosmeceuticals, LTDc52a1e04-f3ca-47a1-a26e-d6f5e77b47d62024-11-14WarningsExact identifier
ndc (product): 58892-107

Reported adverse events (FAERS/openFDA)#

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