Label: EIGHT HOUR CREAM INTENSIVE DAILY MOISTURIZER FOR FACE SPF 15- octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 67938-0866-1, 67938-0866-2 - Packager: Elizabeth Arden, Inc
- Category: HUMAN OTC DRUG LABEL
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 July 27, 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, 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
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - PURPOSE
- OTC - WHEN USING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EIGHT HOUR CREAM INTENSIVE DAILY MOISTURIZER FOR FACE SPF 15
octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67938-0866 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.94 g in 49 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 1.47 g in 49 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.98 g in 49 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:67938-0866-1 1 in 1 BOX 1 NDC:67938-0866-2 49 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/06/2008 Labeler - Elizabeth Arden, Inc (849222187)