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Eight Hour Cream Intensive Daily Moisturizer For Face SPF 15

Dosage form: cream
Ingredients: OCTINOXATE 2.94g in 49g, OXYBENZONE 1.47g in 49g, AVOBENZONE 0.98g in 49g
Labeler: Elizabeth Arden, Inc
NDC Code: 67938-0866

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.

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.

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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE2.94 g  in 49 g
OXYBENZONE (OXYBENZONE) OXYBENZONE1.47 g  in 49 g
AVOBENZONE (AVOBENZONE) AVOBENZONE0.98 g  in 49 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
DIMETHICONE 
BUTYLOCTYL SALICYLATE 
STEARETH-2 
SHEA BUTTER 
PETROLATUM 
CETEARYL GLUCOSIDE 
ALUMINUM STARCH OCTENYLSUCCINATE 
BUTYLENE GLYCOL 
HYALURONATE SODIUM 
TREHALOSE 
UREA 
ALLANTOIN 
C10-30 CHOLESTEROL/LANOSTEROL ESTERS 
PANTHENOL 
STEARYL ALCOHOL 
STEARETH-21 
CITRAL 
GERANIOL 
BENZOIC ACID 
METHYLPARABEN 
PHENOXYETHANOL 
PROPYLPARABEN 
CHLORPHENESIN 
Packaging
#Item CodePackage Description
1NDC:67938-0866-11 TUBE (1 TUBE) 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: 07/2011
 
Elizabeth Arden, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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