FDA.reportPublic FDA data

TiZO Photoceutical AM Replenish - 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 - Tinted
Active ingredientZINC OXIDE
Label structure7 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 16%

(Purpose)

OTC - PURPOSE SECTION

Sunscreen

Directions:

INDICATIONS & USAGE SECTION

Apply liberally 15 minutes before sun exposure.

Warning:

WARNINGS SECTION

For external use only.

Warning and Directions:

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-101-05TiZO Photoceutical AM Replenish - Tinted5 g in 1 TUBECREAM51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-101TIZO PHOTOCEUTICAL AM REPLENISH - TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]1Current NDC, Legacy NDC, 1 package rows20250212_2cc84aba-006b-a78e-e063-6294a90ae040.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58892-10158892-101-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
ZINC OXIDESOI2LOH54ZACTIB
CERAMIDE 34370DF050BIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
DIMETHICONE92RU3N3Y1OIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
IRON OXIDES1K09F3G675IACT
CYCLOPENTASILOXANE0THT5PCI0RIACT

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TIZO PHOTOCEUTICAL AM REPLENISH - TINTEDZINC OXIDEFallien Cosmeceuticals, LTD4e7c4702-5707-6c3e-e063-6394a90a05fd2026-04-02WarningsExact identifier
ndc (product): 58892-101
TiZO Photoceutical AM Replenish - TintedZINC OXIDEFallien Cosmeceuticals, LTD2cc73c4f-30ea-0a51-e063-6394a90ac9a42025-01-28WarningsExact identifier
ndc (product): 58892-101
TiZO Photoceutical AM Replenish - TintedZINC OXIDEFallien Cosmeceuticals, LTD2cc84aba-006b-a78e-e063-6294a90ae0402025-01-28WarningsExact identifier
ndc (package): 58892-101-05
ndc (product): 58892-101
ndc11 (package): 58892010105
spl id: 2cc84aba-006c-a78e-e063-6294a90ae040
spl set id: 2cc84aba-006b-a78e-e063-6294a90ae040
TiZO Photoceutical AM Replenish - TintedZINC OXIDEFallien Cosmeceuticals, LTDfbafa468-fce0-4597-bcb0-a816dc71ec7c2024-11-12WarningsExact identifier
ndc (product): 58892-101

Reported adverse events (FAERS/openFDA)#

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