KARANJA TREE SUNSHIELD SPF 30 MOLTON BROWN SKIN CARE (AVOBENZONE, ENSULIZOLE, OCTINOXATE, OCTOCRYLENE) CREAM [MOLTON BROWN LTD]

KARANJA TREE SUNSHIELD SPF 30 MOLTON BROWN SKIN CARE (AVOBENZONE, ENSULIZOLE, OCTINOXATE, OCTOCRYLENE) CREAM [MOLTON BROWN LTD]
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NDC 68814-128-01, 68814-128-02
Set ID ef38aa70-9d8c-44ec-8dd5-033eb0c778c4
Category HUMAN OTC DRUG LABEL
Packager Molton Brown LTD
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients  Purpose

    Avobenzone 3% Sunscreen

    Ensulizole 3%      Sunscreen

    Octinoxate 7.5%  Sunscreen

    Octocrylene 2%   Sunscreen

    Use

    Provides high protection against sunburn - For skin highly sensitive to sunburn.

    keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

    indications

    Stop use and ask a doctor if skin rash or irritation occurs.

    Warnings

    For external use only.

    Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer and other harmful effects of the sun.

    When using this product, keep out of eyes. Rinse with water to remove.

    Directions

    -Apply generously before sun exposure

    -reapply as needed or after towel drying, swimming, or sweating.

    Inactive ingredients

     Acrylate/acrylamide copolymer, aluminum starch octenylsuccinate, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl glycol, chlorphenesin, cyclohexasiloxane, cyclopentasiloxane, dimethicone, diethylhexyl carbonate, disodium EDTA, ethylhexyl benzoate, ethyhexyl methoxycrylene,fragrance (parfum), glycerin, glyceryl stearate, hydrogenated coco-glycerides, isohexadecane, Peg-100 stearate, phenyl trimethicone, phenoxyethanol, pongamal, polysorbate 80, potassium sorbate, potassium cetylphosphate, Pueraria Lobata root extract, Sorbitan oleate, sorbic acid, Tocopheryl acetate, triethanolamine, water (aqua).

  • PRINCIPAL DISPLAY PANEL

    image of back label

    image of front label

    Molton Brown Skin Care
    Karanja Tree Sunshield SPF30 50ml 1.7 fl oz

  • INGREDIENTS AND APPEARANCE
    KARANJA TREE SUNSHIELD SPF 30  MOLTON BROWN SKIN CARE
    avobenzone, ensulizole, octinoxate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68814-128
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE3 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    SORBIC ACID (UNII: X045WJ989B)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68814-128-021 in 1 BOX
    1NDC:68814-128-0150 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/30/2010
    Labeler - Molton Brown LTD (769334822)
    Registrant - Molton Brown LTD (769334822)
    Establishment
    NameAddressID/FEIBusiness Operations
    DDD Ltd.216339804manufacture(68814-128)

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