Label: ULTA SPF 45- zinc oxide powder

  • NDC Code(s): 58443-0393-2
  • 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 August 24, 2021

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  • Active ingredients

    Zinc Oxide 25%

  • 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

    Do not use on damaged or broken skin

    When using this product

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor

    Stop use and ask a doctor if rash occurs

    Keep out of reach of children.

    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.

    use a water resistant sunscreen if swimming or sweating.

    reapply at least every 2 hours.

    Sunscreen 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 or higher and other sun protection measures including:

    limit time in the sun, especially from 10am - 2pm.

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

    children under 6 months: ask a doctor.

  • Inactive ingredients

    Calcium Aluminum Borosilicate, Silica, Nylon-6/12, Triethoxycaprylylsilane, Olive Glycerides, Ascorbyl Palmitate, Iron Oxides, Ceramide NP

  • Other information

    protect this product from excessive heat and direct sun.

    may stain some fabrics or surfaces.

  • Questions or comments?

    Call 1-866-983-8582

  • Ulta Beauty Mineral Hair & Scalp Powder Broad Spectrum SPF 45

    Principle Display Label

  • INGREDIENTS AND APPEARANCE
    ULTA  SPF 45
    zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0393
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.25 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CERAMIDE NP (UNII: 4370DF050B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    NYLON 612 (MW 14000) (UNII: E7LN56Z3RX)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Product Characteristics
    Coloryellow (Beige) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0393-220 g in 1 BOTTLE; Type 0: Not a Combination Product03/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/04/2021
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0393) , pack(58443-0393) , manufacture(58443-0393) , analysis(58443-0393)
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