EIGHT HOUR CREAM INTENSIVE DAILY MOISTURIZER FOR FACE SPF 15- octinoxate 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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BB0866

DESCRIPTION

This daily hydrating lotion leaves skin feeling soft, smooth, and moisturized for up to 8 hours. Protects skin from the effects of extreme weather and climate changes while SPF 15 shields from the harmful effects of the sun.

INDICATIONS AND USAGE

To Use: Smooth on to cleansed face and throat daily before sun exposure.

WARNINGS

Warning: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rash appear. If irritation or rash persists, consult a doctor. Keep out of reach of children.

OTC - ACTIVE INGREDIENT

Active Ingredients: Octinoxate 6.0% W/W, Oxybenzone 3.0% W/W, Avobenzone 2.0% W/W.

INACTIVE INGREDIENT

Other Ingredients: Water/Aqua/Eau, Cyclopentasiloxane, Glycerin, Dimethicone, Butyloctyl Salicylate, Steareth-2, Methylheptyl Isostearate, Butyrospermum Parkii (Shea Butter), Petrolatum, Cetearyl Glucoside, Aluminum Starch Octenylsuccinate, Butylene Glycol, Aloe Barbadensis Leaf Juice, Sodium Hyaluronate, Tocopheryl Acetate, Sodium PCA, Trehalose, Urea, Allantoin, C10-30 Cholesterol/Lanosterol Esters, Panthenonl, Phospholipids, Stearyl Alcohol, PEG/PPG-20/15 Dimethicone, Seareth-21, Polyquaternium-51, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polethylene, Triethanolamine, Disodium EDTA, Dimethicone Crosspolymer Phenyl Methicone, Parfum/Fragrance, Citral, Citronellol, Geraniol, Limonene, Linalool, Benzoic Acid, Methyparaben, Phenoxyethanol, Chlorphenesin.

DOSAGE & ADMINISTRATION

Smooth on to face.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTC - PURPOSE

Provides SPF 15 sun protection.

OTC - WHEN USING

Avoid contact with eyes.

8HrIntenseFaceBox

8HrIntenseFaceTube

EIGHT HOUR CREAM INTENSIVE DAILY MOISTURIZER FOR FACE SPF 15 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0866
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.94 g  in 49 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1.47 g  in 49 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.98 g  in 49 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
STEARETH-2 (UNII: V56DFE46J5)  
SHEA BUTTER (UNII: K49155WL9Y)  
PETROLATUM (UNII: 4T6H12BN9U)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TREHALOSE (UNII: B8WCK70T7I)  
UREA (UNII: 8W8T17847W)  
ALLANTOIN (UNII: 344S277G0Z)  
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
PANTHENOL (UNII: WV9CM0O67Z)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
STEARETH-21 (UNII: 53J3F32P58)  
CITRAL (UNII: T7EU0O9VPP)  
GERANIOL (UNII: L837108USY)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67938-0866-11 in 1 BOX
1NDC:67938-0866-249 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/06/2008
Labeler - Elizabeth Arden, Inc (849222187)

Revised: 7/2011
Document Id: ef12b107-049f-43c9-acaa-552bda7c8fdb
Set id: f8a442e6-8652-47a8-b3d1-ca454d32d159
Version: 1
Effective Time: 20110727
 
Elizabeth Arden, Inc