Label: SPA SKILHA HELIOPROT AB SPF 40- bemotrizinol,octinoxate,avobenzone,titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated June 7, 2012

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  • ACTIVE INGREDIENT

    Ethylhexyl methoxycinnamate, butyl methoxydibenzoylmethane, titanium dioxide and bis-ethylhexyl oxyphenol methoxyphenyl triazine offers total protection and wide spectrum against the UVA and UVB.

  • PURPOSE

    As dermoprotective solar screen, moisturizes and nourishes. Delays photo-aging and prevents skin cancer.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Use this product when you exposed to the sun. SPF 40 UVA / UVB

  • WARNINGS

    Avoid contact with eyes, do not use in the children under (6) six months of age.

  • DOSAGE & ADMINISTRATION

    - Apply generously before sun exposure.
    - Reapply after (6) six hours.
  • INACTIVE INGREDIENT

    Its composition is photo stable, perfectly adjusted to any state and any contidtion of the skin.

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF THE LABEL  IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    SPA SKILHA   HELIOPROT AB SPF 40
    bemotrizinol,octinoxate,avobenzone,titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66854-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL1.5 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE4 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW) (UNII: 5WE8P977RQ)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66854-025-019 g in 1 JAR
    2NDC:66854-025-0233 g in 1 JAR
    3NDC:66854-025-0360 g in 1 TUBE
    4NDC:66854-025-0520 in 1 BOX
    4NDC:66854-025-0415 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/30/2012
    Labeler - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
    Registrant - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
    Establishment
    NameAddressID/FEIBusiness Operations
    SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS880172184analysis, label, manufacture, pack
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