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ELF Tinted Moisturizer SPF 20 (J. A. Cosmetics U.S. INC)

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Dosage Form Package Information Links
CREAM 25 g in 1 BOTTLE (76354-015-01) Label Information

Complete ELF Tinted Moisturizer SPF 20 Information

  • ACTIVE INGREDIENT

    Active Ingredient:

    Benzophenone-3: 3.5%

    Octyl methoxycinnamate: 6%

    Titanium Dioxide: 5%


  • PURPOSE

    Purpose:

    Sunscreen


  • INDICATIONS & USAGE

    Uses:

    Help prevent sunburn


  • WARNINGS

    Warning:

    For external use only

    Skin Cancer/Skin Aging Alert:

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

    Do not use on damaged or broken skin.


  • WHEN USING

    When Using This Product:

    Avoid contact with 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:

    Apply generally 15 minutes prior to sun exposure.

    Apply to clean skin in an upward and outward motion with a makeup sponge or foundation brush

    Children under six months of age: ask a doctor.

    Reapply at least every two hours

    Use a water resistant sunscreen if swimming or sweating


  • STORAGE AND HANDLING


    Other Information

    Protect this product in its container from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Water, Mineral Oil, Cyclomethicone, C12-15 Akyl Benzoate, Propylene Glycol, Dimethicone, Steareth-21, Cetearyl Alcohol, Ceteareth-2, Glyceryl Stearate, Xanthan Gum, Methylparaben, Propylparaben, Tocopherol (VE), Retinyl Acetate (VA), Ascorbyl Palmitate (VC), Aloe Barbadensis (Aloe Vera) Leaf Juice, Cucumis Sativus (Cucumber) Fruit Extract

    May Contain: Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891)



  • PRINCIPAL DISPLAY PANEL

    lablabel


  • INGREDIENTS AND APPEARANCE
    ELF TINTED MOISTURIZER SPF 20 
    oxybenzone cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76354-015
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3.5 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    MINERAL OIL (UNII: T5L8T28FGP)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARETH-21 (UNII: 53J3F32P58)  
    WATER (UNII: 059QF0KO0R) 38.83 g  in 100 g
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CUCUMBER JUICE (UNII: 61845009SP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76354-015-01 25 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 10/10/2011
    Labeler - J. A. Cosmetics U.S. INC (186705047)
    Registrant - J. A. Cosmetics U.S. INC (186705047)
    Establishment
    Name Address ID/FEI Business Operations
    Shanghai J. A. Cosmetics Trading CO., LTD. 421280183 manufacture