MALLY FACE DEFENDER FOUNDATION BB - 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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Drug Facts

mally Face Defender BB - Tan


Active Ingredients

Titanium Dioxide 4.50%

Zinc Oxide 3.00%

Purpose

Sunscreen

Sunscreen

Use

Warnings

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 Crosspolymer, 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)

Other Information

Distibuted by Mallygirl LLC

P.O. Box 42727

Baltimore, MD 21284-2727

Product made in USA

Principal Display Panel

mally

Face Defender BB

cream foundation

BROAD SPECTRUM SPF 15

Tube

Tube Label

Box

Drug Facts Label Box

MALLY FACE DEFENDER FOUNDATION BB 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76119-1445
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.39 mg  in 53.2 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.59 mg  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)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (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)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
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)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76119-1445-11 in 1 BOX
153.2 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/03/2014
Labeler - MallyGirl, LLC (167262554)

Revised: 2/2014
Document Id: a65b3ae4-8b1c-4a87-b4cc-9529c1ea8d3f
Set id: a1035405-c805-434d-96a3-6468d66a9ff2
Version: 1
Effective Time: 20140204
 
MallyGirl, LLC