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

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ACTIVE INGREDIENTS:
Titanium Dioxide 4%
Zinc Oxide 5.5%

PURPOSE:Sunscreen

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 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: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 the reach of
children.

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 – 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 Reference

PROCEUTICALS PRIVATE LABEL BY TIZO MINERAL LIP SUNSCREEN 
titanium dioxide, zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-212
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE55 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58892-212-454.5 g in 1 TUBE; Type 0: Not a Combination Product07/16/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02007/16/2024
Labeler - Fallien Cosmeceuticals, LTD (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372analysis(58892-212)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing Inc. (FMI)793406000pack(58892-212) , manufacture(58892-212)

Revised: 7/2024
Document Id: 1d613623-a712-8791-e063-6394a90a3b25
Set id: 1d611494-648b-6e5f-e063-6294a90a4500
Version: 1
Effective Time: 20240716
 
Fallien Cosmeceuticals, LTD