PROCEUTICALS PRIVATE LABEL BY TIZO MINERAL LIP SUNSCREEN- titanium dioxide, zinc oxide stick

PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreen by

Drug Labeling and Warnings

PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreen by is a Otc medication manufactured, distributed, or labeled by Fallien Cosmeceuticals, LTD, Custom Analytics LLC, Fragrance Manufacturing Inc. (FMI). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:
Titanium Dioxide 4%
Zinc Oxide 5.5%

PURPOSE

PURPOSE:Sunscreen

INDICATIONS & USAGE

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

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

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of
children.

DOSAGE & ADMINISTRATION

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.

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

INGREDIENTS AND APPEARANCE

PROCEUTICALS PRIVATE LABEL BY TIZO MINERAL LIP SUNSCREEN 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-212
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	55 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
DIPROPYLENE GLYCOL CAPRYLATE (UNII: CJ981S4H3T)
KIWI FRUIT OIL (UNII: 66086CWP3Q)
HEXYLDECANOL (UNII: 151Z7P1317)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CITRUS AURANTIIFOLIA FRUIT OIL (UNII: 7937R189CB)
CERESIN (UNII: Q1LS2UJO3A)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
GINGER OIL (UNII: SAS9Z1SVUK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-212-45	4.5 g in 1 TUBE; Type 0: Not a Combination Product	07/16/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/16/2024

Labeler - Fallien Cosmeceuticals, LTD (958388357)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(58892-212)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc. (FMI)		793406000	pack(58892-212) , manufacture(58892-212)