Label: CERAMIDE PLUMP PERFECT LIP MOISTURE SPF 30- octinoxate cream

  • 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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  • 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

    To Use: Smooth over and around lips before sun exposure and lipstick application.

  • 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. Clinically, dermatologist, and allergy tested.

  • OTC - ACTIVE INGREDIENT

    Active Ingredients: Octinoxate 7.50 %, Octisalate 5.00%, Avobenzone 3.00%, Oxybenzone 2.70%.

  • 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

    Smooth over and around lips.

  • OTC - KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OTC - PURPOSE

    Provides SPF 30 sun protection.

  • OTC - WHEN USING

    Avoid contact with eyes.

  • PRINCIPAL DISPLAY PANEL

    PlumpPerfectLipBox

    PlumpPerfectLipTube

  • INGREDIENTS AND APPEARANCE
    CERAMIDE PLUMP PERFECT LIP MOISTURE SPF 30 
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0967
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.091 g  in 14.55 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.7275 g  in 14.55 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.4365 g  in 14.55 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.3928 g  in 14.55 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-0967-11 in 1 BOX
    1NDC:67938-0967-214.55 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/30/2004
    Labeler - Elizabeth Arden, Inc (849222187)