VISIBLE DIFFERENCE SKIN BALANCING SUNSCREEN SPF 15- octinoxate and oxybenzone lotion

VISIBLE DIFFERENCE SKIN BALANCING SUNSCREEN SPF 15 by

Drug Labeling and Warnings

VISIBLE DIFFERENCE SKIN BALANCING 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 lightweight, oil-free lotion for combination skin leaves skin feeling healthy and balanced with a radiant appearance.

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. Children under 6 months: Ask a doctor.

WARNINGS

Warnings:

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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 6.0 %, Oxybenzone 3.0 %

INACTIVE INGREDIENT

Inactive Ingredients: Water/Aqua/Eau, Dimethicone, Isononyl Isononanoate, Glycerin, Tridecyl Salicylate, Steareth-21, Isostearic Acid, Octyldodecyl Neopentanoate, Aluminum Starch Octenylsuccinate, Salvia Officinalis (Sage) Leaf Extract, Hydrolyzed Glycosaminoglycans, Sodium Hyaluronate, Sodium Lactate, Retinyl Linoleate, Tetrahexyldecyl Ascorbate, Tocopherol, Glyceryl Stearate, Propylene Glycol, Panthenol, C12-20 Acid PEG-8 Ester, Cetyl Alcohol, PEG-100 Stearate, Trilaureth-4 Phosphate, Steareth-2 Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylene/VA Copolymer, Sclerotium Gum, Triethanolamine, BHT, Disodium EDTA, Parfum/Fragrance, Benxyl Salicylate, Butylphenyl Methylpropional, Citronellol, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool, DMDM Hydantoin, Methylparaben, Phenoxyethanol, Propylparaben.

DOSAGE & ADMINISTRATION

Smooth on to face.

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.

OTC - WHEN USING

Keep out of eyes.

PRINCIPAL DISPLAY PANEL

 

INGREDIENTS AND APPEARANCE

VISIBLE DIFFERENCE SKIN BALANCING SUNSCREEN SPF 15 
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-1000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
GLYCERIN (UNII: PDC6A3C0OX)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
STEARETH-21 (UNII: 53J3F32P58)
ISOSTEARIC ACID (UNII: X33R8U0062)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
SAGE (UNII: 065C5D077J)
HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM LACTATE (UNII: TU7HW0W0QT)
RETINYL LINOLEATE (UNII: 61911N8D6W)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PANTHENOL (UNII: WV9CM0O67Z)
PEG-100 STEARATE (UNII: YD01N1999R)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
STEARETH-2 (UNII: V56DFE46J5)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
DMDM HYDANTOIN (UNII: BYR0546TOW)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-1000-1	1 in 1 CARTON
1	NDC: 67938-1000-2	50 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/16/2011

Labeler - Elizabeth Arden, Inc (849222187)