ELIZABETH ARDEN MOISTURE SHIELD SPF 15- octinoxate lotion

Elizabeth Arden Moisture Shield SPF 15 by

Drug Labeling and Warnings

Elizabeth Arden Moisture Shield SPF 15 by is a Otc medication manufactured, distributed, or labeled by Elizabeth Arden, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ELIZABETH ARDEN MOISTURE SHIELD SPF 15 
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-0801
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.125 mL  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 mL  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1 mL  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.75 mL  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-0801-1	1 in 1 BOX
1	NDC: 67938-0801-2	50 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/26/2006

Labeler - Elizabeth Arden, Inc (849222187)