Label: ORCHID SECRET FOUNDATION 21 SPF28 PA PLUS PLUS- titanium dioxide, octinoxate, zinc oxide 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 August 27, 2012

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  • ACTIVE INGREDIENT

    Active Ingredients: TITANIUM DIOXIDE 7.9%, ETHYLHEXYL METHOXYCINNAMATE 3%, ZINC OXIDE 1.9%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    WATER, CYCLOPENTASILOXANE, TALC, DIPROPYLENE GLYCOL, GLYCERIN, PEG-10 DIMETHICONE, CYCLOMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, HEXYLDECYL MYRISTOYL METHYLAMINOPROPIONATE, NIACINAMIDE, PHENYL TRIMETHICONE, IRON OXIDES, BETAINE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, HEXYL LAURATE, NELUMBO NUCIFERA FLOWER WATER, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, C12-14 PARETH-3, ACRYLATES/DIMETHICONE COPOLYMER, PHENOXYETHANOL, METHICONE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, SILICA, PALMITIC ACID, FRAGRANCE, METHYLPARABEN, PROPYLPARABEN, TOCOPHERYL ACETATE, PULSATILLA KOREANA EXTRACT, USNEA BARBATA (LICHEN) EXTRACT, ZANTHOXYLUM PIPERITUM FRUIT EXTRACT, DIOSPYROS KAKI LEAF EXTRACT, HYDROGENATED LECITHIN, RUBUS FRUTICOSUS (BLACKBERRY) FRUIT EXTRACT, SEA WATER, ACACIA SENEGAL FLOWER/STEM EXTRACT, ARNICA MONTANA FLOWER EXTRACT, CENTAUREA CYANUS FLOWER EXTRACT, DIANTHUS CARYOPHYLLUS FLOWER EXTRACT, FREESIA REFRACTA EXTRACT, IRIS VERSICOLOR EXTRACT, JASMINUM OFFICINALE (JASMINE) FLOWER/LEAF EXTRACT, ZANTEDESCHIA AETHIOPICA FLOWER/STEM EXTRACT,
    HYDROGENATED VEGETABLE OIL, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, NEOFINETIA FALCATA CALLUS CULTURE EXTRACT, BUTYLPARABEN, ADENOSINE, SODIUM HYALURONATE, XANTHAN GUM, PEARL POWDER, ALUMINUM SILICATE, LECITHIN

  • PURPOSE

    Purpose: This smooth foundation makes your skin feel soft as velvet texture.

  • WARNINGS

    Cautions:
    For external use only.
    Avoid contact with eyes and mouth.
    Discontinue use if signs of irritation or rash appear.
    Keep out of reach of children.
    Replace the cap after use.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS AND USAGE

    How to Use: Apply an appropriate amount to the skin evenly.

  • DOSAGE AND ADMINISTRATION

    How to Use: Apply an appropriate amount to the skin evenly.

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ORCHID SECRET FOUNDATION  21 SPF28 PA PLUS PLUS
    titanium dioxide, octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51346-032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.76 g  in 35 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.05 g  in 35 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.66 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TALC (UNII: 7SEV7J4R1U)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51346-032-0135 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/15/2012
    Labeler - NATURE REPUBLIC CO., LTD. (631172020)
    Registrant - NATURE REPUBLIC CO., LTD. (631172020)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURE REPUBLIC CO., LTD.631172020manufacture(51346-032)