Label: ELIZABETH ARDEN MOISTURE SHIELD SPF 15- octinoxate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 67938-0801-1, 67938-0801-2 - Packager: Elizabeth Arden, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated August 3, 2011
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- DESCRIPTION
- INDICATIONS AND USAGE
- WARNINGS
- OTC - ACTIVE INGREDIENT
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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
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - PURPOSE
- OTC - WHEN USING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ELIZABETH ARDEN MOISTURE SHIELD SPF 15
octinoxate lotionProduct 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)