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