VISIBLE DIFFERENCE SKIN BALANCING SUNSCREEN SPF 15- octinoxate and oxybenzone lotion 
Elizabeth Arden, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BB1000

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.

VDSBL-CARTON

VDSBL-ONSERT

VDSBL-TUBE

 

VISIBLE DIFFERENCE SKIN BALANCING SUNSCREEN SPF 15 
octinoxate and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-1000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67938-1000-11 in 1 CARTON
1NDC:67938-1000-250 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/16/2011
Labeler - Elizabeth Arden, Inc (849222187)

Revised: 5/2013
Document Id: 28434e69-3527-4030-bb7a-3f551a30bf9f
Set id: d1560161-3114-4ff3-8cc1-2a1d99d95fd3
Version: 1
Effective Time: 20130501
 
Elizabeth Arden, Inc