FDA.reportPublic FDA data

Proceuticals Private Label by TiZO non-tinted mineral sunscreen stick

Manufacturer
Fallien Cosmeceuticals, Ltd | Fragrance Manufacturing Inc. (FMI) | Custom Analytics LLC
Effective date
2024-08-30
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:18:23

Label at a glance#

ProductProceuticals Private Label by TiZO non-tinted mineral sunscreen stick
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

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:DIRECTIONS: Apply liberally 15 minutes before
sun exposure. Reapply: • After 80 mintues of
swimming or sweating • Immediately after towel
drying • 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: Alumina,
Aluminum Hydroxide, Aluminum Stearate,
Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl
Benzoate, Cetearyl Isononanoate, Cetyl
PEG/PPG-15/15 Butyl Ether Dimethicone,
Citric Acid, Ethylene Brassylate, Ethylhexyl
Palmitate, Helianthus Annuus (Sunflower)
Wax, Hexyldecanol, Hexyldecyl Laurate,
Lecithin, Ozokerite, PEG-8, Polyglyceryl-3
Diisostearate, Polyhydroxystearic Acid,
Propylene Glycol Dicaprylate/Dicaprate,
Stearic Acid, Tocopherol, Tocopheryl Acetate,
Zingiber Officinale (Ginger) Root Oil

OTHER SAFETY INFORMATION

OTHER INFORMATION: • Protect this product
from excessive heat and direct sun

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 the 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 – 30g Cylinder Label

PROCEUTICALS

PRIVATE LABEL by TiZO

non-tinted mineral

sunscreen stick

broad spectrum spf 45
water resistant (80 minutes)

Net Wt. 1 oz. /30 g

Graphic-Untitled

Reference NT Stick proceuticals 58892-219-30Reference NT Stick proceuticals 58892-219-30

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-219-30Proceuticals Private Label by TiZO non-tinted mineral sunscreen stick30 g in 1 CYLINDERSTICK305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-219PROCEUTICALS PRIVATE LABEL BY TIZO NON-TINTED MINERAL SUNSCREEN STICK (TITANIUM DIOXIDE, ZINC OXIDE) STICK [FALLIEN COSMECEUTICALS, LTD]5Current NDC, 1 package rows20240901_20e86260-d641-c9ac-e063-6394a90ac07d.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58892-21958892-219-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
CERESINQ1LS2UJO3AIACT
TOCOPHEROLR0ZB2556P8IACT
HEXYLDECANOL151Z7P1317IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
GINGER OILSAS9Z1SVUKIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)8INO2K35FAIACT
ETHYLHEXYL PALMITATE2865993309IACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ASCORBYL PALMITATEQN83US2B0NIACT
ETHYLENE BRASSYLATE9A87HC7RODIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HEXYL LAURATE4CG9F9W01QIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
CETEARYL ISONONANOATEP5O01U99NIIACT
ALUMINUM STEARATEU6XF9NP8HMIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIPROPYLENE GLYCOL CAPRYLATECJ981S4H3TIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
ALUMINUM OXIDELMI26O6933IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT

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 mineral sunscreen stickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd20e86260-d641-c9ac-e063-6394a90ac07d2024-08-30WarningsExact identifier
ndc (package): 58892-219-30
ndc (product): 58892-219
ndc11 (package): 58892021930
spl id: 20e8449a-b638-e458-e063-6394a90a9bc0
spl set id: 20e86260-d641-c9ac-e063-6394a90ac07d

Reported adverse events (FAERS/openFDA)#

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