VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 3- octinoxate, titanium dioxide, octisalate, and oxybenzone cream

VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 3 by

Drug Labeling and Warnings

VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 3 by is a Otc medication manufactured, distributed, or labeled by Elizabeth Arden, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

This protective daytime BB Cream provides high protection from sun and pollution as it instantly hydrates and brightens skin. Imparts a smooth, even toned look and a soft, translucent glow.

INDICATIONS AND USAGE

Smooth onto cleansed face and throat.

WARNINGS

For external use only

OTC ACTIVE INGREDIENT

OCTINOXATE 7.5%..............Sunscreen

TITANIUM DIOXIDE 5.74% ..Sunscreen

OCTISALATE 5.0%...............Sunscreen

OXYBENZONE 3.0%............Sunscreen

INACTIVE INGREDIENT

Water/Aqua/Eau, Butylene Glycol, Dimethicone, Caprylyl Methicone, C20-40 Pareth-3, Glycerin, Phenyl Trimethicone, Peg-8 Dimethicone, Steareth-21, Cyclopentasiloxane, Dipropylene Glycol, Silica, Stearic Acid, Adenosine, Allantoin, Alumina, Aminomethyl Propanol, Ammonium Polyacrylate, Caprylyl Glycol, Citrus Aurantium Amara (Bitter Orange) Fruit Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Cnidium Officinale Root Extract, Cyclohexasiloxane, Decarboxy Carnosine HCL, Decylene Glycol, Dipotassium Glycyrrhizate, Disodium EDTA, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Lecithin, Mica, Parfum/Fragrance, Peg-10 Dimethicone, Polymethyl Methacrylate, Polysilicone-11, Polysorbate 60, Potassium Cetyl Phosphate, Potassium Hydroxide, Sodium Ascorbyl Phosphate, Sodium Hyaluronate, Steareth-2, Stearyl Alcohol, Tocopherol, Tocopheryl Acetate, VP/Eicosene Copolymer, Xanthan Gum, BHT, Sodium Ascorbate, Butylphenyl Methylpropional, Citronellol, Geraniol, Hexyl Cinnamal, Limonene, Linalool, Phenoxyethanol [May Contain/peut Contenir (+/-) Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891)]

DOSAGE AND ADMINISTRATION

Smooth onto face and throat

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTC - PURPOSE

Provides SPF 30 sun protection

OTC - WHEN USING

Keep out of eyes. Rinse with water to remove

DO NOT USE

Do not use

on damaged or broken skin

STOP USE

If rash occurs

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 3 
octinoxate, titanium dioxide, octisalate, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-2004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.55 g  in 34 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.95 g  in 34 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.7 g  in 34 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1.02 g  in 34 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
C20-40 PARETH-3 (UNII: 68103A23TQ)
GLYCERIN (UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
STEARETH-21 (UNII: 53J3F32P58)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
STEARIC ACID (UNII: 4ELV7Z65AP)
ADENOSINE (UNII: K72T3FS567)
ALLANTOIN (UNII: 344S277G0Z)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DECYLENE GLYCOL (UNII: S57M60MI88)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
ISOHEXADECANE (UNII: 918X1OUF1E)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MICA (UNII: V8A1AW0880)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
STEARETH-2 (UNII: V56DFE46J5)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM ASCORBATE (UNII: S033EH8359)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
GERANIOL (UNII: L837108USY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

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: 67938-2004-1	1 in 1 BOX
1	NDC: 67938-2004-2	34 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/17/2013

Labeler - Elizabeth Arden, Inc (849222187)