FDA.reportPublic FDA data

Proceuticals Private Label by TiZO non-tinted replenishing daily protection

Manufacturer
Fallien Cosmeceuticals, Ltd | Custom Analytics LLC | Fragrance Manufacturing Inc. (FMI)
Effective date
2024-09-13
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:19:55

Label at a glance#

ProductProceuticals Private Label by TiZO non-tinted replenishing daily protection
Active ingredientZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:

Zinc Oxide 16%

OTC - PURPOSE SECTION

PURPOSE:Sunscreen

USES: 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.

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:
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

OTHER SAFETY INFORMATION

OTHER INFORMATION: • Protect this product
from excessive heat and direct sun • May stain
some fabrics

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 befor sun exposure.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel – 50g Bottle Label

PROCEUTICALS

PRIVATE LABEL by TiZO

non-tinted replenishing
daily protection

broad spectrum spf 40
with ceramides, zinc oxide
& antioxidants C & E

net wt. 1.75 oz / 50 g

Graphic-Untitled

Reference 58892-226-50 Replenish NT proceuticals NDC-01Reference 58892-226-50 Replenish NT proceuticals NDC-01

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-226-50Proceuticals Private Label by TiZO non-tinted replenishing daily protection50 g in 1 BOTTLE, PUMPCREAM507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-226PROCEUTICALS PRIVATE LABEL BY TIZO NON-TINTED REPLENISHING DAILY PROTECTION (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]7Current NDC, 1 package rows20240922_2203ea22-d12a-99fe-e063-6394a90aca9f.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
58892-22658892-226-50

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
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CYCLOMETHICONE 6XHK3U310BAIACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CYCLOMETHICONE 50THT5PCI0RIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
CERAMIDE NP4370DF050BIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
DIMETHICONE 20H8YMB5QY0DIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Proceuticals Private Label by TiZO non-tinted replenishing daily protectionZINC OXIDEFallien Cosmeceuticals, Ltd2203ea22-d12a-99fe-e063-6394a90aca9f2024-09-13WarningsExact identifier
ndc (package): 58892-226-50
ndc (product): 58892-226
ndc11 (package): 58892022650
spl id: 2203fdf1-a23e-fb32-e063-6394a90a03d5
spl set id: 2203ea22-d12a-99fe-e063-6394a90aca9f

Reported adverse events (FAERS/openFDA)#

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