PROCEUTICALS PRIVATE LABEL BY TIZO DAILY DEFENSE TINTED MINERAL SUNSCREEN- titanium dioxide, zinc oxide cream 
Fallien Cosmeceuticals, LTD

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ACTIVE INGREDIENTS:
Titanium Dioxide 10%
Zinc Oxide 3%

PURPOSE:Sunscreen

DIRECTIONS:
• Apply liberally 15 minutes before sun exposure.
• Reapply:
• After 40 minutes of swimming or sweating
• Immediately after towel drying
• 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 INGREDIENTS:
Bismuth Oxychloride, Capric/Caprylic Triglyceride,
Caprylhydroxamic Acid, Caprylyl Glycol, Ceteareth-20,
Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Disodium
EDTA, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Iron Oxides,
Isododecane, Isohexadecane, Melissa Officinalis (Balm Mint)
Extract, Mica, Microcrystalline Wax, Octyldodecyl Neopentanoate,
PEG-30 Dipolyhydroxystearate, Sodium Chloride, Tetrahexyldecyl
Ascorbate, Tocopheryl Acetate, Tocopherol, Triethanolamine,
Triethoxycaprylylsilane, Water

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

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.

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

daily defense tinted
mineral sunscreen

broad spectrum spf 50
water resistant (40 minutes)

net wt. 1.8 oz / 53 g

Graphic-Untitled

58892-258-50 proceuticals reference

PROCEUTICALS PRIVATE LABEL BY TIZO DAILY DEFENSE TINTED MINERAL SUNSCREEN 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-258
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE30 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYL HYDROXYSTEARATE BENZOATE (UNII: 3W8F25684B)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
MELISSA OFFICINALIS WHOLE (UNII: YF70189L0N)  
WATER (UNII: 059QF0KO0R)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ISODODECANE (UNII: A8289P68Y2)  
MICA (UNII: V8A1AW0880)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58892-258-5053 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/08/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02007/08/2024
Labeler - Fallien Cosmeceuticals, LTD (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372analysis(58892-258)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing Inc. (FMI)793406000pack(58892-258) , manufacture(58892-258)

Revised: 7/2024
Document Id: 1cc19337-cf55-af5d-e063-6394a90a1ceb
Set id: 1cc19337-cf54-af5d-e063-6394a90a1ceb
Version: 1
Effective Time: 20240708
 
Fallien Cosmeceuticals, LTD