BURBERRY FRESH GLOW B.B. LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 FAIR 01 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [BURBERRY LIMITED]

BURBERRY FRESH GLOW B.B. LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 FAIR 01 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [BURBERRY LIMITED]
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NDC 69038-001-00
Set ID 974dfd4a-cbcc-4f6a-b64e-9c3079765e2d
Category HUMAN OTC DRUG LABEL
Packager Burberry Limited
Generic Name
Product Class
Product Number
Application Number PART352
  • BURBERRY FRESH GLOW B.B. CREAM LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 FAIR 01


  • Active ingredients

    Octinoxate 6%
    Titanium dioxide 2%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.
  • Warnings

    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

    • Apply liberally 15 min before sun exposure
    • Reapply at least every 2 hrs
    • Use a water resistant sunscreen if swimming or sweating
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10am-2pm
    • Wear long-sleeved shirts, pants, hats and sunglasses
    • Children under 6 months of age: Ask a doctor
  • Other information

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

    water, diethylhexyl carbonate, ethylhexyl stearate, diisostearoyl polyglyceryl-3 dimer dilinoleate, cyclopentasiloxane, microcrystalline wax, hydrogenated castor oil, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, silica, hexyl laurate, sodium chloride, phenoxyethanol, cetyl dimethicone, potassium sorbate, sodium dehydroacetate, dimethicone, corn oil, nylon-12 fluorescent brightener 230 salt, propylene glycol dicaprylate/dicaprate, caprylic/capric triglyceride, tetrasodium EDTA, fragrance, hydrogenated vegetable oil, ascorbyl palmitate, tea (camellia sinensis) leaf extract, tocopheryl acetate, aminomethyl propanol, alpha-isomethyl ionone, polyvinylalcohol crosspolymer, spanish lavender (lavandula stoechas) extract, BHT, benzyl benzoate, hydroxycitronellal, dog rose (rosa canina) fruit extract, mica, titanium dioxide, iron oxides.

  • BURBERRY FRESH GLOW B.B. CREAM LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 FAIR 01 30ml (69038-001-00)

    Burberry Fair 30ml TubeBurberry Fair 30ml

  • INGREDIENTS AND APPEARANCE
    BURBERRY FRESH GLOW B.B. LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 FAIR 01  
    octinoxate, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69038-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CORN OIL (UNII: 8470G57WFM)  
    PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LAVANDULA STOECHAS WHOLE (UNII: MTZ2ZA34ZV)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69038-001-001 in 1 CARTON
    130 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/16/2014
    Labeler - Burberry Limited (210047627)
    Establishment
    NameAddressID/FEIBusiness Operations
    Intercos Europe S.p.A.438961310manufacture(69038-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Intercos Europe S.p.A.339447428manufacture(69038-001)

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