ELF FLAWLESS FINISH FOUNDATION OIL FREE SPF 15 SUNSCREEN LIGHT IVORY (TITANIUM DIOXIDE) CREAM [J. A. COSMETICS U.S. INC]

ELF FLAWLESS FINISH FOUNDATION OIL FREE SPF 15 SUNSCREEN LIGHT IVORY (TITANIUM DIOXIDE) CREAM [J. A. COSMETICS U.S. INC]
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NDC 76354-631-01
Set ID aa8df265-c098-4c67-b68b-2eeff0f45591
Category HUMAN OTC DRUG LABEL
Packager J. A. Cosmetics U.S. INC
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredient:

    Titanium Dioxide: 4.45%

    Octinoxate: 4.0%

    Octisalate: 3.0%

  • PURPOSE

    Purpose:

    Sunscreen

  • INDICATIONS & USAGE

    Uses:

    Helps prevent sunburn

  • WARNINGS

    Warning:

    For external use only

    Skin Cancer/ Skin Aging Alert:

    Spending time in the sun increases your increases your risk of sking cancer or early skin aging. This product has been shown only to help prevent sunburn not sking cancer or skin aging.

  • WHEN USING

    When using this product:

    Keep out of eyes. Rinse with water to remove.

  • ASK DOCTOR

    Stop Use and Ask a Doctor if:

    Rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children

  • DOSAGE & ADMINISTRATION

    Directions:

    For suncreen use:

    Apply generally 15 min before sun exposure.

    Children under six months of age: ask a doctor

    Reapply at least every two hours.

    Use a water resistant sunscreen if swimming or sweating

    Sun Protection Measures:

    Spending time in sun increases your risk of skin cancer or early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures including

    • Limit time in the sun, especially from 10 am to 2 pm
    • Wear long sleeved shirts, pants, hats, and sunglasses.
    • Children under six months of age: ask a doctor

    Other Information:

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

    Store at room temperature 15C-30C (59F-86F)

  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Water (Aqua), Glycerin, Isododecane, Dimethicone, Cyclopentasiloxane, Propylene Glycol, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Tridecyl Trimellitate, Sorbitan Sesquioleate, Cyclohexasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Polymethyl Methacrylate, Boron Nitride, Magnesium Sulfate, Magnesium Stearate, PEG/PPG-15/15 Dimethicone, Disteardimonium Hectorite, Silica Dimethyl Silylate, Aluminum Hydroxide, Triethoxycaprylylsilane, Silica, Alumina, Fragrance (Parfum), Phenoxyethanol, Caprylyl Glycol, EthylhexylglycerinMA

    May contain:

    Iron Oxides (CI 77491, CI 77492, CI 77499)

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ELF FLAWLESS FINISH FOUNDATION OIL FREE SPF 15 SUNSCREEN LIGHT IVORY 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-631
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.45 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    TRIEPOXYCYCLOHEXASILANE (UNII: 066Q83563R)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
    PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76354-631-0120 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/26/2017
    Labeler - J. A. Cosmetics U.S. INC (186705047)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Ayan Biotech Co., Ltd.544377996manufacture(76354-631)

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