Label: RIMMEL LONDON MOISTURE RENEW LIPGLOSS - FUSCIA THERAPHY (345)- octinoxate, octisalate 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 October 20, 2010

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  • INDICATIONS & USAGE

    USE: Helps prevent sunburn.
  • WARNINGS

    WARNING: Stop use if skin rash occurs.
  • ACTIVE INGREDIENT

    Active Ingredients: Octinoxate 7.5%, Octisalate 2.0%.













  • INACTIVE INGREDIENT

    COSMETIC INGREDIENTS: POLYBUTENE, HYDROGENATED
    POLYISOBUTENE, PARAFFINUM LIQUIDUM/MINERAL OIL/
    HUILE MINERALE, ETHYLHEXYL PALMITATE, LANOLIN OIL,
    ETHYLENE/PROPYLENE/STYRENE COPOLYMER, POLYETHYLENE,
    CALCIUM ALUMINUM BOROSILICATE, SILICA DIMETHYL
    SILYLATE, SILICA, SYNTHETIC FLUORPHLOGOPITE,

    ISOPROPYLPARABEN,BUTYLENE/ETHYLENE/STYRENE
    COPOLYMER, TOCOPHERYL ACETATE, PENTAERYTHRITYL
    TETRAISOSTEARATE, BUTYLPARABEN, ISOBUTYLPARABEN,
    PARFUM/FRAGRANCE, TRIBEHENIN, CARMINE, LINALOOL, BHT,
    ASCORBYL PALMITATE, RETINYL PALMITATE, TIN OXIDE,
    HYDROXYCITRONELLAL, SORBITAN ISOSTEARATE, HEXYL

    CINNAMAL, BUTYLENE GLYCOL, PALMITIC ACID,
    PHENOXYETHANOL, METHYLPARABEN, SODIUM CHONDROITIN
    SULFATE, PROPYLPARABEN, CAPRYLYL GLYCOL, ATELOCOLLAGEN,
    SODIUM HYALURONATE, HEXYLENE GLYCOL, PALMITOYL
    OLIGOPEPTIDE, ETHYLPARABEN. [MAY CONTAIN/PEUT CONTENIR/
    : MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES

    (CI 77491, CI 77492, CI 77499), DandC RED NO. 7 CALCIUM LAKE
    (CI 15850), DandC RED NO. 6 BARIUM LAKE (CI 15850), FDandC
    YELLOW NO. 5 ALUMINUM LAKE (CI 19140), DandC RED NO. 33
    ALUMINUM LAKE (CI 17200), FDandC BLUE NO. 1 ALUMINUM LAKE
    CI 42090), FDandC YELLOW NO. 6 ALUMINUM LAKE (CI 15985),
    DandC RED NO. 27 ALUMINUM LAKE (CI 45410)].


  • PRINCIPAL DISPLAY PANEL

    RIMMEL LONDON

    SPF 15 SUNSCREEN

    MOISTURE RENEW

    WITH COLLAGEN AND VITAMINS A, C and E

    CREAM LIPGLOSS

    0.20 fl oz 6 ml


    Principal_Display_Panel.jpg


    Ingredients_Color_345.jpg


    Use


  • INGREDIENTS AND APPEARANCE
    RIMMEL LONDON  MOISTURE RENEW LIPGLOSS - FUSCIA THERAPHY (345)
    octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59351-0310
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE.012 mL  in 6 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE.12 mL  in 6 mL
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    LANOLIN (UNII: 7EV65EAW6H)  
    ETHYLENE (UNII: 91GW059KN7)  
    ALUMINUM (UNII: CPD4NFA903)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ISOPROPYLPARABEN (UNII: A6EOX47QK0)  
    ETHYLENE (UNII: 91GW059KN7)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    SORBITAN (UNII: 6O92ICV9RU)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SULFATE ION (UNII: 7IS9N8KPMG)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    IRON (UNII: E1UOL152H7)  
    CALCIUM (UNII: SY7Q814VUP)  
    BARIUM (UNII: 24GP945V5T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59351-0310-16 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/20/2010
    Labeler - Lancaster S.A.M. (401011325)
    Registrant - Rimmel Inc. (965020402)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lancaster S.A.M.401011325manufacture