Label: BURBERRY CASHMERE LONG-LASTING FLAWLESS SOFT-MATTE FOUNDATION SUNSCREEN SPF20 CAMEL- octinoxate, octinoxate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 25, 2017

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  • Drug Facts

  • Active ingredients

    Octinoxate 3.49%

    Octisalate 4.00%

    Purpose

    Sunscreen

  • Uses

    • Helps Prevent Sunburn.
  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    For external use only.

    Do not use

    • on damaged or broken skin.

    When using this product

    • keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if

    • rash occurs.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Reapp ly at least every 2 hrs.
    • Use a water resistant sunscreen if swimming or sweating.
    • Apply liberal ly 15 mins before sun exposure.
    • Children under 6 months of age: Ask a doctor.
  • Other information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients

    Water, Cyclopentasiloxane, Methyl Trimethicone, Isododecane, Butylene Glycol, PEG/PPG-18/18 Dimethicone, Diphenyl Dimethicone/Vinyl Diphenyl Dimethicone/Silsesquioxane Crosspolymer, Methyl Methacrylate Crosspolymer, PEG-10 Dimethicone, Phenyl Trimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Glycerin, Sodium Chloride, Octyldodecanol, Alcohol, Acrylates/Dimethicone Copolymer, VP/VA Copolymer, Caprylyl Methicone, Phenoxyethanol, Triethyl Citrate, Disteardimonium Hectorite, Caprylyl Glycol, Tocopheryl Acetate, Triethoxycaprylylsilane, Propylene Carbonate, Disodium EDTA, Gum Arabic Tree (Acacia Senegal) Gum, Xanthan Gum, Sodium Hyaluronate, Dog Rose (Rosa Canina) Fruit Extract, BHT, Tea (Camellia Sinensis) Leaf Extract, Citric Acid, Tocopherol, Sodium Benzoate, Potassium Sorbate, Spanish Lavender (Lavandula Stoechas) Extract. May Contain: Titanium Dioxide, Bismuth Oxychloride, Iron Oxides.

  • Package Labeling

    camel no.42

  • INGREDIENTS AND APPEARANCE
    BURBERRY CASHMERE LONG-LASTING FLAWLESS SOFT-MATTE FOUNDATION SUNSCREEN SPF20 CAMEL 
    octinoxate, octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69038-035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE34.9 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    ISODODECANE (UNII: A8289P68Y2)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    ALCOHOL (UNII: 3K9958V90M)  
    PVP/VA COPOLYMER (UNII: D9C330MD8B)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TEA LEAF (UNII: GH42T47V24)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69038-035-301 in 1 PACKAGE11/07/2015
    130 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/07/2015
    Labeler - Burberry Limited (210047627)
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