FLAWLESS FINISH BARE PERFECTION MAKEUP SPF 8 BISQUE- octinoxate lotion

Flawless Finish Bare Perfection Makeup SPF 8 Bisque by

Drug Labeling and Warnings

Flawless Finish Bare Perfection Makeup SPF 8 Bisque by is a Otc medication manufactured, distributed, or labeled by Elizabeth Arden, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLAWLESS FINISH BARE PERFECTION MAKEUP SPF 8 BISQUE 
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-0825
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.1988 mL  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	PINK (Bisque)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-0825-1	1 in 1 BOX
1	NDC: 67938-0825-2	30 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/06/2011

Labeler - Elizabeth Arden, Inc (849222187)