MAKEUP SUN PRIMER (OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE) CREAM [STW ENTERPRISE INC.]

MAKEUP SUN PRIMER (OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE) CREAM [STW ENTERPRISE INC.]
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NDC 70117-001-01, 70117-001-02
Set ID 1be9d02e-64c1-4a62-9549-e0819c9d811f
Category HUMAN OTC DRUG LABEL
Packager STW ENTERPRISE INC.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Ethylhexyl Methoxycinnamate 7.00%
    Titanium Dioxide 4.11%
    Zinc Oxide 4.93%

  • 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

    Cyclopentasiloxane, Dimethicone, Cyclohexasiloxane, Silica, Triethylhexanoin, Phenethyl Benzoate, Butyrospermum Parkii (Shea) Butter, Bis-Ethylhexyloxyphenol MethoxyphenylTriazine, Dimethicone/Vinyl Dimethicone Crosspolymer, Ceresin, Cholesteryl Isostearate, Trimethylsiloxysilicate, PEG-10 Dimethicone, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Citrus Grandis (Grapefruit) Peel Oil, Ocimum Basilicum (Basil) Oil, Geranium Maculatum Oil, Propylene Glycol, Hydroxypropyl Bisstearamide MEA, Macadamia Integrifolia Seed Oil, Butylene Glycol, Argania Spinosa Kernel Oil, Dipropylene Glycol, Behenyl Alcohol, Ceteareth-20, Cholesterol, Cetearyl Alcohol, Squalane, Tricaprin

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MAKEUP SUN PRIMER 
    octinoxate, zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70117-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 mg  in 50 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.47 mg  in 50 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.06 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    BEMOTRIZINOL (UNII: PWZ1720CBH)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    CERESIN (UNII: Q1LS2UJO3A)  
    CHOLESTERYL ISOSTEARATE (UNII: JD5KDN9464)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
    BASIL OIL (UNII: Z129UMU8LE)  
    GERANIUM MACULATUM ROOT OIL (UNII: H2E371EDYX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROXYPROPYL BISSTEARAMIDE MONOETHANOLAMIDE (UNII: EQ4H84545F)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SQUALANE (UNII: GW89575KF9)  
    TRICAPRIN (UNII: O1PB8EU98M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70117-001-021 in 1 PACKAGE12/08/2015
    1NDC:70117-001-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/08/2015
    Labeler - STW ENTERPRISE INC. (051490151)
    Registrant - STW ENTERPRISE INC. (051490151)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nowcos Co., Ltd.689914984manufacture(70117-001)

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