JUNGSAEMMOOL ESSENTIAL STAR CEALER FOUNDATION MEDIUM (TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE) CREAM [JUNGSAEMMOOL BEAUTY CO., LTD.]

JUNGSAEMMOOL ESSENTIAL STAR CEALER FOUNDATION MEDIUM (TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE) CREAM [JUNGSAEMMOOL BEAUTY CO., LTD.]
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NDC 71261-006-01, 71261-006-02
Set ID 34dc9b4f-fd4f-49f7-8975-1047c9589eaa
Category HUMAN OTC DRUG LABEL
Packager Jungsaemmool Beauty Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Titanium Dioxide 12.80%
    Octinoxate 4.00%
    Zinc Oxide 0.98%

  • 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, Phenyl Trimethicone, Triethylhexanoin, Cyclopentasiloxane, Dipropylene Glycol, PEG-10 Dimethicone, Cyclohexasiloxane, Niacinamide, Butylene Glycol Dicaprylate/Dicaprate, Pentylene Glycol, Iron Oxides (CI 77492), Methyl Methacrylate Crosspolymer, Polypropylsilsesquioxane, Disteardimonium Hectorite, Trimethylsiloxyphenyl Dimethicone, Magnesium Sulfate, Phenoxyethanol, Silica, Lauroyl Lysine, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Beeswax, Sorbitan Isostearate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Iron Oxides (CI 77491), Triethoxycaprylylsilane, Iron Oxides (CI 77499), Aluminum Hydroxide, Ceresin, Stearic Acid, Dimethicone, Fragrance(Parfum), Ethylhexylglycerin, Dimethicone Crosspolymer, Adenosine, Disodium EDTA, Silica Dimethyl Silylate, Nelumbo Nucifera Flower Water, Mica (CI 77019), Tocopherol, Tin Oxide (CI 77861)

  • 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 STAR CEALER FOUNDATION MEDIUM 
    titanium dioxide, octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71261-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE128 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION9.8 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CERESIN (UNII: Q1LS2UJO3A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    ADENOSINE (UNII: K72T3FS567)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)  
    MICA (UNII: V8A1AW0880)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71261-006-021 in 1 CARTON12/06/2017
    1NDC:71261-006-0115 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 finalpart35212/06/2017
    Labeler - Jungsaemmool Beauty Co., Ltd. (694214725)
    Registrant - Jungsaemmool Beauty Co., Ltd. (694214725)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc689049693manufacture(71261-006)

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