Label: THE FLOWER UV INTENSE PACT SPF50 PA NB23- zinc oxide powder

  • 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 July 14, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients: ZINC OXIDE, TITANIUM DIOXIDE

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    MICA(CI 77019), TALC, METHYL METHACRYLATE CROSSPOLYMER, ETHYLHEXYL METHOXYCINNAMATE, BORON NITRIDE, PHENYL TRIMETHICONE, DIMETHICONE, SILICA,
    ETHYLHEXYL PALMITATE, IRON OXIDES(CI 77492), TRIETHOXYCAPRYLYLSILANE, METHICONE, CAPRYLIC/CAPRIC TRIGLYCERIDE, METHYLPARABEN, IRON OXIDES(CI 77491),
    FRAGRANCE, IRON OXIDES(CI 77499), HYDROGENATED LECITHIN, BUTYLPARABEN, ROSA CANINA FLOWER, JASMINUM OFFICINALE (JASMINE) FLOWER,
    ANTHEMIS NOBILIS FLOWER POWDER, PHALAENOPSIS AMABILIS EXTRACT, DENDROBIUM PHALAENOPSIS FLOWER EXTRACT, CAMELLIA JAPONICA FLOWER EXTRACT,
    LILIUM CANDIDUM BULB EXTRACT, IMPATIENS BALSAMINA FLOWER EXTRACT, PELARGONIUM GRAVEOLENS EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT,
    HIBISCUS ROSA-SINENSIS FLOWER/LEAF EXTRACT, TROPAEOLUM MAJUS FLOWER/LEAF/STEM EXTRACT

  • 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.

  • PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    THE FLOWER UV INTENSE PACT  SPF50 PA NB23
    zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-024
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE1.65 g  in 12 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE1.54 g  in 12 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51523-024-0112 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/01/2007
    Labeler - THEFACESHOP CO., LTD. (688329416)