MALLY FACE DEFENDER FOUNDATION BB- titanium dioxide, zinc oxide cream

mally Face Defender Foundation BB by

Drug Labeling and Warnings

mally Face Defender Foundation BB by is a Otc medication manufactured, distributed, or labeled by MallyGirl, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

mally Face Defender BB - Medium Light

Active Ingredients

Titanium Dioxide 4.50%

Zinc Oxide 3.00%

Purpose

Sunscreen

Sunscreen

Use

• 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.

Warnings

For external use only

DO NOT USE

Do not use on damaged or broken skin.

STOP USE

Stop use and ask doctor if rash occurs.

WHEN USING

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

KEEP OUT OF REACH OF CHILDREN

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

Directions

• Apply liberally 15 minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
• Children under 6 months: ask a doctor
• Sun Protection Measures. Spending time in the sun increases risk of skin cancer and early aging. To decrease this risk regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higer and other sun protection measures including
• Limit time in the sun especially from 10:00 a.m. - 2:00 p.m.
• Wear long sleeved shirts, pants, hats and sunglasses
  

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

• Protect this product from excessive heat and direct sun.
  

SPL UNCLASSIFIED SECTION

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

Box

INGREDIENTS AND APPEARANCE

MALLY FACE DEFENDER FOUNDATION BB 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76119-1442
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.39 mg  in 53.2 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.59 mg  in 53.2 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76119-1442-1	1 in 1 BOX
1		53.2 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/03/2014

Labeler - MallyGirl, LLC (167262554)