FLAWLESS FINISH BARE PERFECTION MAKEUP SPF 8 CREAM- octinoxate lotion 
Elizabeth Arden, Inc

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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BC0823

DESCRIPTION

For normal skin. Medium coverage. Natural finish. This oil free liquid makeup gives skin a firmer look and reflects light to soften fine lines. SPF 8 provides sun protection. Clinically, dermatologist and allergy tested.

INDICATIONS AND USAGE

To Use: Smooth on to face before sun exposure.

WARNINGS

Warning: For external use only. Keep out of eyes.Stop use and see a doctor is rash or irritation develops and lasts. Keep out of reach of children.

OTC - ACTIVE INGREDIENT

Active Ingredient: Octinoxate 4.0% w/w.

INACTIVE INGREDIENT

Other Ingredients: Water/Aqua/Eau, Isostearyl Palmitate, C12-15 Alkyl Benzoate, Butylene Glycol, Dimethicone, Oleic Acid, Glycerin, C12-20 Acid PEG-8 Ester, Polysorbate 40, Triethanolamine, Magnesium Aluminum Silicate, Dimethicone Copolyol, Phenyl Trimethicone, Sodium Hyaluronate, Retinyl Linoleate, Tocopherol, Glyceryl Stearate SE, Sucrose Laurate, Trehalose, Lecithin, Phospholipids, Tridecyl Salicylate, Decyl Glucoside, PEG-40 Stearate, Sorbitan Palmitate, Sorbitan Stearate, Behenyl Alcohol, Carbomer, Xanthan Gum, Disodium EDTA, Kaolin, Silica, Cyclopentasiloxane, Dimethiconol, Parfum/Fragrance, Butylphenyl Methylpropional, Hydroxycitronellal, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Propylparaben, Iron Oxides (CI77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891).

DOSAGE & ADMINISTRATION

Smooth on to face.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTC - PURPOSE

SPF 8 provides sun protection.

OTC - WHEN USING

Keep out of eyes.

Flawless Finish Bare Perfection Makeup Carton

FLAWLESS FINISH BARE PERFECTION MAKEUP SPF 8 CREAM 
octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0823
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.1988 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
OLEIC ACID (UNII: 2UMI9U37CP)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 40 (UNII: STI11B5A2X)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
TROLAMINE (UNII: 9O3K93S3TK)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
KAOLIN (UNII: 24H4NWX5CO)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SUCROSE LAURATE (UNII: 05Q7CD0E49)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DOCOSANOL (UNII: 9G1OE216XY)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)  
Product Characteristics
ColorPINK (Cream) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67938-0823-11 in 1 BOX
1NDC:67938-0823-230 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/06/2011
Labeler - Elizabeth Arden, Inc (849222187)

Revised: 5/2011
Document Id: bdff6bd1-cd7f-4f41-a2a6-78f36c5ec0b1
Set id: 53abf705-8808-46f0-bf22-62d6320fbf8e
Version: 1
Effective Time: 20110506
 
Elizabeth Arden, Inc