Label: JUNGSAEMMOOL ESSENTIAL SKIN NUDER CUSHION LIGHT- titanium dioxide, octinoxate, octisalate cream

  • NDC Code(s): 71261-001-01, 71261-001-02, 71261-001-03, 71261-001-04
  • Packager: Jungsaemmool Beauty 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 July 1, 2021

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  • ACTIVE INGREDIENT

    Titanium Dioxide 13.19%
    Octinoxate 6.70%
    Octisalate 4.00%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Helps prevent sunburn

  • DOSAGE & ADMINISTRATION

    Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

    Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

    Ask a doctor to use for children under 6 months

  • WARNINGS

    For external use only

    Do not use on damaged or broken skin

    When using this product, keep out of eyes. Rinse with water to remove.

    Stop using and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

  • INACTIVE INGREDIENT

    Water, Cyclopentasiloxane, Trimethylsiloxysilicate, Glycerin, PEG-10 Dimethicone, Butylene Glycol, Niacinamide, Cetyl Ethylhexanoate, Pentylene Glycol, Iron Oxides (CI 77492), VP/Hexadecene Copolymer, Caprylyl Methicone, Polypropylsilsesquioxane, Magnesium Sulfate, Phenoxyethanol, Cetyl PEG/PPG-10/1 Dimethicone, Synthetic Fluorphlogopite, Stearic Acid, Disteardimonium Hectorite, Iron Oxides (CI 77491), Alumina, Acrylates/Dimethicone Copolymer, Aluminum Hydroxide, Triethoxycaprylylsilane, Dimethicone, Fragrance(Parfum), Iron Oxides (CI 77499), Ethylhexylglycerin, Dimethicone Crosspolymer, Adenosine, Disodium EDTA, Dimethicone/Vinyl Dimethicone Crosspolymer, Mica (CI 77019), Tin Oxide (CI 77861), Polyglutamic Acid

  • OTHER SAFETY INFORMATION

    Protect the product in the container from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    JUNGSAEMMOOL ESSENTIAL SKIN NUDER CUSHION LIGHT 
    titanium dioxide, octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71261-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE67 mg  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE131.9 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    ADENOSINE (UNII: K72T3FS567)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    MICA (UNII: V8A1AW0880)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71261-001-021 in 1 CARTON10/16/2020
    1NDC:71261-001-0114 g in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:71261-001-042 in 1 CARTON10/16/2020
    2NDC:71261-001-0314 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 finalpart35210/16/2020
    Labeler - Jungsaemmool Beauty Co., Ltd. (694214725)
    Registrant - Jungsaemmool Beauty Co., Ltd. (694214725)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc689049693manufacture(71261-001)
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