Label: DERMAPROT HELIOPROT AB SPF 30- octinoxate,titanium dioxide,oxybenzone,avobenzone lotion

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated June 7, 2012

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  • ACTIVE INGREDIENT

    ETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, BUTYL METHOXYDIBENZOYLMETHANE, BENZOPHENONE-3, are a set of physical and chemical filters that provide SPF 30

  • PURPOSE

    Sunscreen lotion from wide spectrum sunscreen SPF 30
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Provides moderate protection against sun. This product is for topical application.

  • WARNINGS

    Avoid the contact with eyes, rinse with water to remove.

    Do not apply this product on under six months aged children

  • DOSAGE & ADMINISTRATION

    Rub to cover the area to be protected and wait for its full absorption

  • INACTIVE INGREDIENT

    Solar protector UVA UVB has an aqeous base where we deposited all the active ingredients to garantee a wide range of the sun protection; rehydrates the skin tissues maintining cellular bioactivity without the inconvenient of the oily foundations.

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF THE CARTON LABEL  IMAGE OF THE CARTON LABEL

  • INGREDIENTS AND APPEARANCE
    DERMAPROT  HELIOPROT AB SPF 30
    octinoxate,titanium dioxide,oxybenzone,avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66854-026
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3 mL  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66854-026-0110 mL in 1 BOTTLE
    2NDC:66854-026-0245 mL in 1 BOTTLE
    3NDC:66854-026-0370 mL in 1 BOTTLE
    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(66854-026) , manufacture(66854-026) , label(66854-026) , pack(66854-026)
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