ULTA BEAUTY BROAD SPECTRUM SPF 30 TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PRIME ENTERPRISES INC.]

ULTA BEAUTY BROAD SPECTRUM SPF 30 TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PRIME ENTERPRISES INC.]
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NDC 58443-0245-3
Set ID 45ae9cae-f902-5ebd-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Prime Enterprises Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    TItanium Dioxide 3%

    Zinc Oxide 3%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • 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 use and ask a doctor if rash occurs

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 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 broad spectrum SPF of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • INACTIVE INGREDIENT

    Allantoin, Alumina, Butyrospermum Parkii (Shea) Butter, Camellia Oleifera (Green Tea) Leaf Extract, Cetyl PEG/PPG-10/1 Dimethicone, Cucumis Sativus (Cucumber) Extract, Cyclopentasiloxane, Dimethicone Crosspolymer, Disteardimonium Hectorite, Ethylhexylglycerin, Fragrance, Glycerin, Hexyl Laurate, Iron Oxides, Linum Usitatissimum (Linseed) Seed Oil, Oenothera Biennis (Evening Primrose) Oil, PEG-10 Dimethicone, Phenoxyethanol, Plankton Extract, Polyglyceryl-4 Isostearate, Polymethylsilsesquioxane, Rosa Canina Fruit Oil, Silica, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Water

  • Other Information

    • protect this product from excessive heat and direct sun
    • avoid contact with fabrics - could cause discoloration
  • Question or comments?

    Call 1-866-983-8582

  • Ulta Beauty SPF 30 Broad Spectrum Tinted Face Mineral Sunscreen

    Principal Display Image

  • INGREDIENTS AND APPEARANCE
    ULTA BEAUTY  BROAD SPECTRUM SPF 30 TINTED MINERAL SUNSCREEN
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0245
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE31.38 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE31.38 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    CUCUMBER (UNII: YY7C30VXJT)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    WATER (UNII: 059QF0KO0R)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0245-359 mL in 1 TUBE; Type 0: Not a Combination Product12/27/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/27/2016
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0245) , manufacture(58443-0245) , label(58443-0245) , analysis(58443-0245)

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