VISIBLE DIFFERENCE GENTLE HYDRATING BROAD SPECTRUM SUNSCREEN SPF 15- octinoxate, avobenzone, and oxybenzone cream 
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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BC1169

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.

VDGHCCarton

VDGHCOnsert

VDGHCJar

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VISIBLE DIFFERENCE GENTLE HYDRATING BROAD SPECTRUM SUNSCREEN SPF 15 
octinoxate, avobenzone, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-1169
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 g  in 50 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 50 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1.5 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67938-1169-11 in 1 CARTON
1NDC:67938-1169-250 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2011
Labeler - Elizabeth Arden, Inc (849222187)

Revised: 5/2013
Document Id: 9730a816-2019-4dd9-90c2-9fe8320017fd
Set id: e8afa7d0-b25e-42ac-9eaa-81d6ad73b790
Version: 1
Effective Time: 20130501
 
Elizabeth Arden, Inc