Label: MAY NEW YORK SECRET MUSE UV VITA SUN CUSHION- zinc oxide, octinoxate, octisalate, homosalate, titanium dioxide powder

  • NDC Code(s): 69777-280-01, 69777-280-02
  • Packager: NATURE & NATURE CO.,LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 June 4, 2018

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  • ACTIVE INGREDIENT

    Active ingredients: ZINC OXIDE 9.00%, ETHYLHEXYL METHOXYCINNAMATE 6.00%, ETHYLHEXYL SALICYLATE 4.00%, HOMOSALATE 3.00%, TITANIUM DIOXIDE 2.00%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    WATER, CYCLOPENTASILOXANE, PROPANEDIOL, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, NIACINAMIDE, SILICA, ALCOHOL, CAPRYLYL METHICONE, BORON NITRIDE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, CICHORIUM INTYBUS (CHICORY) ROOT EXTRACT, CAMELLIA JAPONICA FLOWER EXTRACT, ORIGANUM VULGARE LEAF EXTRACT, CHAMAECYPARIS OBTUSA LEAF EXTRACT, SALIX ALBA (WILLOW) BARK EXTRACT, LACTOBACILLUS/SOYBEAN FERMENT EXTRACT, PORTULACA OLERACEA EXTRACT, CINNAMOMUM CASSIA BARK EXTRACT, TOCOPHERYL ACETATE, SCUTELLARIA BAICALENSIS ROOT EXTRACT, ARCTIUM LAPPA ROOT EXTRACT, CRYPTOMERIA JAPONICA LEAF EXTRACT, NELUMBO NUCIFERA LEAF EXTRACT, SACCHAROMYCES FERMENT FILTRATE, LINUM USITATISSIMUM (LINSEED) SEED EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, HIBISCUS ESCULENTUS FRUIT EXTRACT, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, 1,2-HEXANEDIOL, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, TRIETHOXYCAPRYLYLSILANE, MICA, SORBITAN CAPRYLATE, GLYCERYL CAPRYLATE, ETHYLHEXYLGLYCERIN, DICAPRYLYL CARBONATE, ADENOSINE, BUTYLENE GLYCOL, GLYCERIN, TOCOPHEROL, MENTHYL PCA, ETHYL MENTHANE CARBOXAMIDE, HYDROGENATED LECITHIN, POLYGLYCERYL-10 STEARATE, PANTHENOL, SODIUM ASCORBYL PHOSPHATE, CAPRYLYL GLYCOL, RETINYL PALMITATE, BIOTIN, CYANOCOBALAMIN, THIAMINE HCL, FOLIC ACID, PYRIDOXINE, FRAGRANCE, CHROMIUM OXIDE GREENS

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings:

    -For external use only

    -Protect the product in the container from excessive heat and direct sun light.

    -When using this product keep out of eyes.

    -Stop use and ask a doctor if rash occurs.

  • DESCRIPTION

    Uses:

    A portable and convenient sun protector provides effective skin defense against damaging UV rays.

    Directions:

    01. Apply daily to face and body.

    02. Apply liberally 15 minutes prior to exposure to sun or UV lights.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MAY NEW YORK SECRET MUSE UV VITA SUN CUSHION 
    zinc oxide, octinoxate, octisalate, homosalate, titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69777-280
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.07 g  in 23 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.38 g  in 23 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.92 g  in 23 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.69 g  in 23 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.46 g  in 23 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69777-280-021 in 1 CARTON05/01/2018
    1NDC:69777-280-0123 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/01/2018
    Labeler - NATURE & NATURE CO.,LTD. (688734179)
    Registrant - NATURE & NATURE CO.,LTD. (688734179)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689512611manufacture(69777-280)