ELIZABETH ARDEN MOISTURE SHIELD SPF 15- octinoxate 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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BB0801

DESCRIPTION

This lightweight, moisturizing lotion provides the ideal level of hydration as it shields skin from the damaging effects of UV rays. Skin feels restored and rebalanced, and looks healthy and glowing.

INDICATIONS AND USAGE

To Use: Smooth on to face 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 6.25% W/W, Octisalate 5.00% W/W, Oxybenzone 2.00% W/W, Avobenzone 1.50% W/W.

INACTIVE INGREDIENT

Other Ingredients: Water/Aqua/Eau, Cyclopentasiloxane, Isostearyl Neopentanoate, Hydrogenated Polyisobutene, Glycerin, Phenyl Trimethicone, Butylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Phenoxyethanol, Petrolatum, PEG-8, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea Butter) Extract, Phospholipids, Pentaerythrityl Tetraethylhexanoate, Cucumis Sativus (Cucumber) Juice, Lycium Chinese Fruit Extract, Panax Ginseng Root Extract, Salvia Officinalis (Sage) Leaf Extract, Vanilla Tahitensis Fruit Extract, Sodium Hyaluronate, Lactic Acid, Tocopheryl Acetate, Arginine, Carnosine, Glycine, Lysine, Proline, Propylene Glycol, Sodium PCA, Trehalose, Urea, Hydrogenated Lecithin, Polyphosphorylcholine Glycol Acrylate, Sucrose, Cetearyl Alcohol, Stearic Acid, Polyquaternium-51, Ethoxydiglycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Xanthan Gum, Citric Acid, Triethanolamine, Sodium Sulfite, Disodium EDTA, Hydroxypropyl Starch Phosphate, Dimethiconol, Parfum/Fragrance, Butylene Methylpropional, Limonene, Benzoic Acid, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Potassium Sorbate, Propylparaben, Sodium Benzoate, Chlorphensin.

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.

MoistureShieldBottle
ELIZABETH ARDEN MOISTURE SHIELD SPF 15 
octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0801
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.125 mL  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 mL  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1 mL  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.75 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PETROLATUM (UNII: 4T6H12BN9U)  
SHEA BUTTER (UNII: K49155WL9Y)  
CUCUMBER JUICE (UNII: 61845009SP)  
LACTIC ACID (UNII: 33X04XA5AT)  
ARGININE (UNII: 94ZLA3W45F)  
CARNOSINE (UNII: 8HO6PVN24W)  
GLYCINE (UNII: TE7660XO1C)  
LYSINE (UNII: K3Z4F929H6)  
PROLINE (UNII: 9DLQ4CIU6V)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TREHALOSE (UNII: B8WCK70T7I)  
UREA (UNII: 8W8T17847W)  
SUCROSE (UNII: C151H8M554)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM SULFITE (UNII: VTK01UQK3G)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67938-0801-11 in 1 BOX
1NDC:67938-0801-250 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/26/2006
Labeler - Elizabeth Arden, Inc (849222187)

Revised: 8/2011
Document Id: ae6f4a9b-b4b6-4642-ac04-553fbd0571b9
Set id: f8832036-fe7a-43a4-849a-26e254ebd95b
Version: 1
Effective Time: 20110803
 
Elizabeth Arden, Inc