FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE GOLDEN NUDE- octinoxate and titanium dioxide lotion

FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE GOLDEN NUDE by

Drug Labeling and Warnings

FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE GOLDEN NUDE by is a Otc medication manufactured, distributed, or labeled by Elizabeth Arden, Inc, Intercos. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Makeup that feels like your own skin, only better. Light, breathable formula smooths on seamlessly for a naturally luminous look that lasts all day. Minimizes the look of pores and imperfections immediately and over time with continued use. Hydro-pigment color technology, vitamins and antioxidants protect and perfect, so skin looks beautifully even-toned and flawless.

INDICATIONS & USAGE

smooth onto face.

WARNINGS

For external use only

OTC - ACTIVE INGREDIENT

OCTINOXATE 4.00%..............Sunscreen

TITANIUM DIOXIDE 1.26%....Sunscreen

INACTIVE INGREDIENT

WATER/AQUA/EAU, ISOHEXADECANE, HEXYL LAURATE, MICA, GLYCERIN, POLYGLYCERYL-4 ISOSTEARATE, POTASSIUM CETYL PHOSPHATE, CETEARYL ALCOHOL, ASCORBYL PALMITATE, BETAINE, CARBOMER, GLYCERYL STEARATE, HYDROLYZED VEGETABLE PROTEIN, LECITHIN, MAGNESIUM ALUMINUM SILICATE, PEG-100 STEARATE, POLYGLYCERYL-10 MYRISTATE, SODIUM HYDROXIDE, TOCOPHERYL ACETATE, TREMELLA FUCIFORMIS SPOROCARP EXTRACT, CHLORPHENESIN, PHENOXYETHANOL, POTASSIUM SORBATE, SODIUM BENZOATE, SODIUM DEHYDROACETATE [MAY CONTAIN/PEUT CONTENIR (+/-) IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

OTC - DO NOT USE

Do not

use on damaged or broken skin

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTC - PURPOSE

Provides SPF 15 sun protection.

OTC - STOP USE

Stop use and ask a doctor if rash occurs

OTC - WHEN USING

keep out of eyes. Rinse with water to remove.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE GOLDEN NUDE 
octinoxate and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-2011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg  in 1500 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	18.9 mg  in 1500 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOHEXADECANE (UNII: 918X1OUF1E)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MICA (UNII: V8A1AW0880)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BETAINE (UNII: 3SCV180C9W)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PEG-100 STEARATE (UNII: YD01N1999R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CHLORPHENESIN (UNII: I670DAL4SZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)

Product Characteristics
Color	BROWN (LIGHT BEIGE)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-2011-1	1 in 1 BOX
1	NDC: 67938-2011-2	1500 mg in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/17/2013

Labeler - Elizabeth Arden, Inc (849222187)

Establishment
Name	Address	ID/FEI	Business Operations
Intercos		883457061	manufacture(67938-2011)