Label: CHARMZONE ALBATROSS POWDER SUN (SPF41 PA)- octinoxate octisalate zinc oxide titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

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 November 9, 2009

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  • KEEP OUT OF REACH OF CHILDREN


    Label1

    WARNINGS:

    For external use only.  Avoid contact with eyes.  Keep out of children's reach.



  • ACTIVE INGREDIENT


    Label2

    INGREDIENTS:

    WATER, ETHYLHEXYL METHOXYCINNAMATE, BUTYLENE GLYCOL, POLYMETHYL METHACRYLATE, ETHYLHEXYL DIMETHYL PABA, ETHYLHEXYL SALICYLATE, HYDROGENATED POLYDECENE, ZINC OXIDE, SILICA, CYCLOMETHICONE, BUTYL METHOXYDIBENZOYLMETHANE, BIOSACCHARIDE GUM-1, TITANIUM DIOXIDE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, CETYL ALCOHOL, CETEARETH-12, GLYCERYL STEARATE, PEG-100 STEARATE, SODIUM HYALURONATE, STEARIC ACID, DIETHOXYETHYL SUCCINATE, GLYCERYL POLYACRYLATE, SORBITAN OLIVATE, BEESWAX, CETEARYL OLIVATE, CETYL PALMITATE, AMMONIUM ACRYLOYLDIMETHYLTAURATE / VP COPOLYMER, PHENOXYETHANOL, SORBITAN PALMITATE, TOCOPHERYL ACETATE, POTASSIUM CETYL PHOSPHATE, METHYLPARABEN, TRIETHOXYCAPRYLYLSILANE, FRAGRANCE, BIFIDA FERMENT LYSATE, BUTYLPARABEN, DIPOTASSIUM GLYCYRRHIZATE, HYDROLYZED SOY PROTEIN, MORUS ALBA ROOT EXTRACT, PEG-1182 METHYL ESTER SERICIN, PROPYLPARABEN, XANTHAN GUM, MAGNESIUM ASCORBYL PHOSPHATE, BHT, DIMETHICON, FOMES OFFICINALIS (MUSHROOM) EXTRACT, DISODIUM EDTA, STEARYL GLYCYRRHETINATE, GLYCOSAMINOGLYCANS, ATELOCOLLAGEN, BAMBUSA  ARUNDINACEA STEM EXTRACT, RUBUS SUAVISSIMUS (RASPBERRY) LEAF EXTRACT, PORTULACA OLEACEA EXTRACT, ANGELICA POLYMORPHA SINENSIS ROOT EXTRACT, ASPALATHUS LINEARIS LEAF EXTRACT, VISCUM ALBUM (MISTLETOE) LEAF EXTRACT

  • WHEN USING


    Label3

    [How to Use]

    1) Before outdoor leisure activities, evenly smooth over face (avoid around the eyes), arms, neck, legs and other areas that might be exposed to sunlight.

    2) It can be used as under-makeup and helps the color makeup adhere to skin and stay on.

  • PRINCIPAL DISPLAY PANEL


    Label4



    LABEL

  • INGREDIENTS AND APPEARANCE
    CHARMZONE ALBATROSS POWDER SUN (SPF41 PA) 
    octinoxate octisalate zinc oxide titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22201-2001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4.91 mL  in 70 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3.15 mL  in 70 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC - UNII:J41CSQ7QDS) ZINC OXIDE2.33 mL  in 70 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE1.225 mL  in 70 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22201-2001-170 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/01/2009
    Labeler - CHARMZONE CO LTD (689049765)
    Registrant - CHARMZONE CO LTD (689049765)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHARMZONE CO LTD689049765manufacture