Label: ARSAINTE ECO THERAPY SUPER REPAIR SUN SPF45- 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 July 12, 2010

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients: TITANIUM DIOXIDE, ZINC OXIDE

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    BETULA PLATYPHYLLA JAPONICA JUICE, DICAPRYLYL CARBONATE, PROPANEDIOL, CYCLOMETHICONE, LAURYL PEG-8 DIMETHICONE, STEARIC ACID, ALUMINUM HYDROXIDE,
    SODIUM CHLORIDE, CETYL DIMETHICONE, RHEUM UNDULATUM ROOT/STALK/STEM EXTRACT, COPTIS CHINENSIS ROOT EXTRACT, TRIHYDROXYSTEARIN, POLYGLYCERYL-6 POLYRICINOLEATE,
    ROSA GALLICA FLOWER EXTRACT, ROSA DAMASCENA FLOWER OIL, EUCALYPTUS GLOBULUS LEAF EXTRACT, ANTHEMIS NOBILIS FLOWER EXTRACT, AESCULUS HIPPOCASTANUM (HORSE CHESTNUT) SEED EXTRACT,
    RIBES NIGRUM (BLACK CURRANT) LEAF EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT, PADINA PAVONICA THALLUS EXTRACT, BUTYLENE GLYCOL,
    CENTELLA ASIATICA EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, MIMOSA PUDICA LEAF EXTRACT, ECHINACEA ANGUSTIFOLIA EXTRACT, PINUS DENSIFLORA BARK EXTRACT,
    SCROPHULARIA BUERGERIANA ROOT EXTRACT, NELUMBO NUCIFERA LEAF EXTRACT, LYCIUM CHINENSE ROOT EXTRACT, KOCHIA SCOPARIA FRUIT EXTRACT,
    CITRUS PARADISI (GRAPEFRUIT) FRUIT EXTRACT, CAPRYLIC/CAPRIC GLYCERIDES, METHYL METHACRYLATE CROSSPOLYMER, CYCLOPENTASILOXANE, PHENYL TRIMETHICONE,
    DIMETHICONE CROSSPOLYMER, DIMETHICONOL, WATER, GLYCERIN, PEG-10 DIMETHICONE, IRON OXIDES(CI 77492), IRON OXIDES(CI 77491), TRIETHOXYCAPRYLYLSILANE,
    DISODIUM EDTA, FRAGRANCE

  • DESCRIPTION

    Warnings:
    When using this product
    Keep out of eyes. Rinse with water to remove.
    Stop use and ask a doctor if
    Rash or irritation develops and lasts.

    Directions:
    Apply evenly before sun exposure and as needed.
    Children under 6months of age; ask a doctor.

  • PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ARSAINTE ECO THERAPY SUPER REPAIR SUN  SPF45
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-002
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE5.55 mL  in 50 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE4.36 mL  in 50 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51523-002-0150 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/01/2009
    Labeler - THEFACESHOP CO., LTD. (688329416)