Label: ULTA BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide lotion

  • NDC Code(s): 58443-0404-3
  • Packager: Prime Enterprises, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 6, 2021

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  • Active ingredients

    Titanium Dioxide 4%

    Zinc Oxide 4%

  • 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 suncreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

    Limit time in the sun, especially from 10 a.m. to 2 p.m.

    Wear long-sleeve shirts, pants, hats, and sunglasses

    Children under 6 months: Ask a doctor

  • Inactive ingredients

    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, 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 Seed 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

  • Questions or comments?

    Call 1-866-983-8582

  • Ulta Beauty Mineral Matte Tinted Face Lotion Broad Spectrum SPF 30

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    ULTA  BROAD SPECTRUM SPF 30
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0404
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE31.5 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE31.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    ROSA CANINA SEED (UNII: 4503R1M9UT)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    ALLANTOIN (UNII: 344S277G0Z)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    CUCUMBER SEED (UNII: BT3S9L53JK)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    Product Characteristics
    Colorbrown (Light Tan) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0404-359 mL in 1 TUBE; Type 0: Not a Combination Product03/16/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/16/2018
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(58443-0404) , label(58443-0404) , analysis(58443-0404) , pack(58443-0404)
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