VISIBLE DIFFERENCE GENTLE HYDRATING BROAD SPECTRUM SUNSCREEN SPF 15- octinoxate, avobenzone, and oxybenzone cream

Visible Difference Gentle Hydrating Broad Spectrum Sunscreen SPF 15 by

Drug Labeling and Warnings

Visible Difference Gentle Hydrating Broad Spectrum Sunscreen SPF 15 by is a Otc medication manufactured, distributed, or labeled by Elizabeth Arden, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

This multi-benefit moisturizer for dry skin provides intense hydration. Leaves skin feeling soft and smooth.

INDICATIONS AND USAGE

To Use: Smooth onto cleansed face and throat.

Directions For Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Sun Protection Measures. Spending time in the sun increases your risk of measures including: Limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeve shirts, pants, decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection hats, and sunglasses.

Children under 6 months ask a doctor.

WARNINGS

Warnings: For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs.

OTC - ACTIVE INGREDIENT

Active Ingredients: Octinoxate 7.5%, Avobenzone 3.0%, Oxybenzone 3.0%.

INACTIVE INGREDIENT

Inactive Ingredients: Water/Aqua/Eau, Butylene Glycol, Glycerin, Isononyl Isononanoate, Dimethicone, Cetearyl Glucoside, Pentylene Glycol, Butyl Stearate, Tridecyl Salicylate, Cetyl Ricinoleate, Cyclopentasiloxane, Narcissus Tazetta Bulb Extrat, Trifolium Pratense (Clover) Flower Extract, Sodium Hyaluronate, Tocopherol, Tocopheryl Acetate, Caprylyl Glycol, Cetearyl Dimethicone Crosspolymer, Ethylhexyl Palmitate, Glyceryl Stearate, Sodium PCA, Trehalose, Urea, Hyrdolyzed Soy Protein, Lecithin, Phospholipids, Polyphophorylcholine Glycol Acrylate, Ammonium Acryloyldimethylaurate/VP Coplymer, PEG-100 Stearate, PEG-8 Laurate, PEG-60 Hydrogenated Castor Oil, Sodium Dodecylbenzenesulfonate, Polyquaternium-51, Styrene/Acrylates Copolymer, Hexylene Glycol, Isododecane, PEG-8, Xanthan Gum, Nylon-12, BHT, Disodium EDTA, Mica, Tin Oxide, Silica Dimethyl Silylate, Parfum/Fragrance, Benzyl Salicylate, Butylphenyl Methylpropional, Citonellol, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limnene, Linalool, Benzoic Acid, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Potassium Sorbate, Propylparaben, Sorbic Acid, Chlorphenesin, Titanium Dioxide (CI 77891).

DOSAGE AND ADMINISTRATION

Smooth on to face and throat.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

OTC - PURPOSE

Provides SPF 15 Sun Protection.

WHEN USING

Keep out of eyes.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VISIBLE DIFFERENCE GENTLE HYDRATING BROAD SPECTRUM SUNSCREEN SPF 15 
octinoxate, avobenzone, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-1169
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.75 g  in 50 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 50 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1.5 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
BUTYL STEARATE (UNII: 6Y0AI5605C)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
CETYL RICINOLEATE (UNII: 1P677500YD)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
NARCISSUS TAZETTA BULB (UNII: K17762966S)
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
TREHALOSE (UNII: B8WCK70T7I)
UREA (UNII: 8W8T17847W)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
PEG-100 STEARATE (UNII: YD01N1999R)
PEG-8 LAURATE (UNII: 762O8IWA10)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ISODODECANE (UNII: A8289P68Y2)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
XANTHAN GUM (UNII: TTV12P4NEE)
NYLON-12 (UNII: 446U8J075B)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MICA (UNII: V8A1AW0880)
STANNIC OXIDE (UNII: KM7N50LOS6)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SORBIC ACID (UNII: X045WJ989B)
CHLORPHENESIN (UNII: I670DAL4SZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-1169-1	1 in 1 CARTON
1	NDC: 67938-1169-2	50 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/15/2011

Labeler - Elizabeth Arden, Inc (849222187)