MALLY FACE DEFENDER FOUNDATION - titanium dioxide, zinc oxide cream 
MallyGirl, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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mally Face Defender - Fair Foundation Broad Spectrum SPF 15

DRUG FACTS


Active Ingredients

Titanium Dioxide 4.50%

Zinc Oxide 3.00%

Purpose

Sunscreen

Sunscreen

Use

For external use only

Do not use on damaged or broken skin.

Stop use and ask doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swollowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

Water (Aqua), Cyclopentaslloxane, Octyldodecyl Neopentanoate, Butylene Glycol, Glycerin, Polyglyceryl-4 Isostearate, Dimethicone Corsspolymer, PEG/PPG 18/18 Dimethicone, Silica, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Stearic Acid, Aluminum Hydroxide, Sodium Dehydroacetate, Phytantriol, Hexyl Laurate, Triethoxycaprylylsilane, Nylon-12, Carbomer, Polysorbate 20, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Sodium Chloride, Tocopherol, Tetrahexyldecyl Ascorbate, Nylon-12 Fluorescent Brightener 230 Salt, Polyvinylalconol Crosspolymer, Magnesium Chloride, Potassium Chloride, Zinc Chloride, Lysine, Sodium Hyaluronate, Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, May Contain: Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499) Product made in the USA

Other Information

Principal Display Panel

mally

Face Defender Foundation
Fair
Broad Specturm SPF 15


Tube Label

Drug Facts Label Carton


MALLY FACE DEFENDER FOUNDATION 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76119-1325
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.39 mL  in 53.2 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.59 mL  in 53.2 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
POLYETHYLENE GLYCOL 900 (UNII: UEP843BRCQ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
PHYTANTRIOL (UNII: 8LVI07A72W)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
NYLON-12 (UNII: 446U8J075B)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
LYSINE (UNII: K3Z4F929H6)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76119-1325-11 in 1 BOX
159.2 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/29/2012
Labeler - MallyGirl, LLC (167262554)

Revised: 3/2012
Document Id: 3014331a-7f13-41cf-9e3e-44113e5a2f47
Set id: 0dbcd913-2a9f-4608-9d9d-f994c7533acd
Version: 1
Effective Time: 20120329
 
MallyGirl, LLC