Label: CERAMIDE PLUMP PERFECT LIP MOISTURE SPF 30- octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 67938-0967-1, 67938-0967-2 - 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 July 18, 2011
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- Official Label (Printer Friendly)
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DESCRIPTION
Lip plumping benefits plus moisture-boosting hydration and SPF 30 protection. Contains Maxi-Lip, a proven lip plump plump, and Argireline, a potent lip plumper. Together they help plump up lip volume and reduce the appearance of vertical lines for smoother, fuller-looking lips. Our moisture-rich Ceramide Triple Complex helps reinforce skin's own natural protective barrier. SPF 30 helps protect from the damaging effects of the sun.
- INDICATIONS AND USAGE
- WARNINGS
- OTC - ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Other Ingredients: Water, Synthetic Beeswax, Pentylene Glycol, Dipentaerythrityl Tetrahyroxystearate/Tetreisostearate, Isostearyl Neopentanoate, Butylene Gloycol, Ceteareth-20, Isostearyl Alcohol, Cetearyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Caprylic/Capric Triglyceride, Butylene Glycol Cocoate, Polymethylmethacrylate, PPG-51/SMDI Coplymer, Ceramide 1, Ceramide 3, Ceramide 6 II, Alpinia Speciosa Leaf Extract, Butrospermum Park II (Shea Butter) Extract, Melissa Oficinalis (Balm Mint) Water, Mentha Piperita (Peppermint) Leaf Water, Rosmarinus Officinalis (Rosemary) Leaf Water, Trifolium Pratense (Clover) Flower Extract, Retinyl Linoleate, Tribehenin, Ethylhexyl Palmitate, Hydrogenated Polysobutene, PEG-40 Hydrogenated Castor Oil, Glycerin, Propylene Glycol, Acetyl Hexapeptide-3, Hydrogenated Lecithin, Lecithin, Palmitoyl Oligopeptide, Phospholipids, Phytospingosine, Polyphosphorylcholine Glycol, Acrylate, Fructose, Sucrose, Ammonium Acryloyldimethyl Taurate/VP Copolymer, BIS-PEG/PPG-16/16PEG/PPG-16/16 Dimethicone, Sorbitan Isostearate, Steareth-2, Tridecth-9, Polyether-1, Ethylcellulose, Ceteth-20, Colesterol, PEG-100 Stearate, Sodium Lauroyl Lactylate, Stearic Acid, Carbomer, Silica, Cyclopentasiloxane, Dimethicone, Flavor, Ammonium Cylcyrrhizate, Menthol, Benzoic Acid, Ethyl Maltol, Methylparaben, Phenoxyethanol, Propylparaben, Chlophenesin.
- DOSAGE & ADMINISTRATION
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - PURPOSE
- OTC - WHEN USING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CERAMIDE PLUMP PERFECT LIP MOISTURE SPF 30
octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67938-0967 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.091 g in 14.55 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.7275 g in 14.55 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.4365 g in 14.55 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.3928 g in 14.55 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PENTYLENE GLYCOL (UNII: 50C1307PZG) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) COCOA BUTTER (UNII: 512OYT1CRR) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYL PALMITATE (UNII: 2865993309) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARETH-2 (UNII: V56DFE46J5) CETETH-20 (UNII: I835H2IHHX) TRIBEHENIN (UNII: 8OC9U7TQZ0) GLYCYRRHIZIN, AMMONIATED (UNII: 3VRD35U26C) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) STEARIC ACID (UNII: 4ELV7Z65AP) CHLORPHENESIN (UNII: I670DAL4SZ) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B) MENTHOL (UNII: L7T10EIP3A) TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) SUCROSE (UNII: C151H8M554) FRUCTOSE (UNII: 6YSS42VSEV) METHYLPARABEN (UNII: A2I8C7HI9T) GLYCERIN (UNII: PDC6A3C0OX) BENZOIC ACID (UNII: 8SKN0B0MIM) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) ETHYL MALTOL (UNII: L6Q8K29L05) PEPPERMINT OIL (UNII: AV092KU4JH) ROSEMARY OIL (UNII: 8LGU7VM393) CERAMIDE 3 (UNII: 4370DF050B) PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C) XANTHAN GUM (UNII: TTV12P4NEE) ACETYL HEXAPEPTIDE-3 (UNII: L4EL31FWIL) PROPYLPARABEN (UNII: Z8IX2SC1OH) ALPINIA ZERUMBET LEAF (UNII: MS8P33AMKX) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) CHOLESTEROL (UNII: 97C5T2UQ7J) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67938-0967-1 1 in 1 BOX 1 NDC:67938-0967-2 14.55 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/30/2004 Labeler - Elizabeth Arden, Inc (849222187)