FDA.reportPublic FDA data

PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreen

Manufacturer
Fallien Cosmeceuticals, LTD | Custom Analytics LLC | Fragrance Manufacturing Inc. (FMI)
Effective date
2024-07-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:15:24

Label at a glance#

ProductPROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreen
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:
Titanium Dioxide 4%
Zinc Oxide 5.5%

OTC - PURPOSE SECTION

PURPOSE:Sunscreen

INDICATIONS & USAGE SECTION

DIRECTIONS:
• Apply liberally 15 minutes before sun exposure.
• Reapply:
• After 80 minutes of swimming or sweating
• Immediately after towel drying
• At least every 2 hours
• Children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Asorbic Acid, Ascorbyl Palmitate, C Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate. Ethylhexyl Palmitate, Flavor, Helianthus Annuus (Sunflower) Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Disostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oi

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. 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 before sun exposure.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel – 53 g Bottle Label

Proceuticals

PRIVATE LABEL by TiZO

non-tinted
mineral sunscreen

broad spectrum spf 40
water resistant (80 minutes)

net wt. 1.8 oz / 53 g

Graphic-Untitled

58892-212-45 mineral lip sunscreen Reference58892-212-45 mineral lip sunscreen Reference

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
58892-212-45PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreen4.5 g in 1 TUBESTICK4.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-212PROCEUTICALS PRIVATE LABEL BY TIZO MINERAL LIP SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) STICK [FALLIEN COSMECEUTICALS, LTD]1Current NDC, 1 package rows20240718_1d611494-648b-6e5f-e063-6294a90a4500.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58892-21258892-212-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALUMINUM OXIDELMI26O6933IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
ALUMINUM STEARATEU6XF9NP8HMIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
HEXYL LAURATE4CG9F9W01QIACT
FERRIC OXIDE RED1K09F3G675IACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ASCORBYL PALMITATEQN83US2B0NIACT
CETEARYL ISONONANOATEP5O01U99NIIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)8INO2K35FAIACT
DIPROPYLENE GLYCOL CAPRYLATECJ981S4H3TIACT
KIWI FRUIT OIL66086CWP3QIACT
HEXYLDECANOL151Z7P1317IACT
ETHYLHEXYL PALMITATE2865993309IACT
CITRUS AURANTIIFOLIA FRUIT OIL7937R189CBIACT
CERESINQ1LS2UJO3AIACT
STEARIC ACID4ELV7Z65APIACT
TOCOPHEROLR0ZB2556P8IACT
GINGER OILSAS9Z1SVUKIACT

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 mineral lip sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1d611494-648b-6e5f-e063-6294a90a45002024-07-16WarningsExact identifier
ndc (package): 58892-212-45
ndc (product): 58892-212
ndc11 (package): 58892021245
spl id: 1d613623-a712-8791-e063-6394a90a3b25
spl set id: 1d611494-648b-6e5f-e063-6294a90a4500

Reported adverse events (FAERS/openFDA)#

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