FLAWLESS FINISH DUAL PERFECTION MAKEUP SPF 8 CREAM- titanium dioxide powder

Flawless Finish Dual Perfection Makeup SPF 8 Cream by

Drug Labeling and Warnings

Flawless Finish Dual Perfection Makeup SPF 8 Cream 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 to oily skin. Adjustable coverage. Matte finish. Ultra fine powder and foundation in one. Wet it's a soft matte makeup. Dry it's a perfectly matte makeup or finishing powder. Ideal for touch-ups. 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 Ingredients: Titanium Dioxide 7.0% w/w, Octinoxate 3.6% w/w.

INACTIVE INGREDIENT

Other Ingredients: Talc, Zinc Stearate, Nylon-12, Dimethicone, Ethylhexyl Palmitate, Pentaerythrityl Tetraethylhexanoate, Methicone, Aluminum Hydroxide, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Propylparaben, Iron Oxides, Mica, Titanium Dioxide.

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 DUAL PERFECTION MAKEUP SPF 8 CREAM 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-1158
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.19 g  in 17 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.59 g  in 17 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
OCTINOXATE (UNII: 4Y5P7MUD51)
ZINC STEARATE (UNII: H92E6QA4FV)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color	PINK (Cream)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-1158-1	1 in 1 BOX
1	NDC: 67938-1158-2	17 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/24/2006

Labeler - Elizabeth Arden, Inc (849222187)