Label: ULTA BEAUTY TINTED MOISTURIZER SPF-30- octinoxate, titanium dioxide, zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 September 28, 2017

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  • Active ingredient(s)

    OCTINOXATE 7.5%

    TITANIUM DIOXIDE 3.5%

    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.

    • May stain some fabrics
  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating.
    • 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 a 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 of age: Ask a doctor
  • Inactive Ingredients

    Purified Water, Cyclopentasiloxane, Isononyl lsononanoate, Phenyl Trimethicone, Alcohol Denat., Lauryl PEG-8 Dimethieone, Disteardimonium Hectorite, Sodium Chloride, PEG-10 Dimethicone, Talc, Caprylyl Glycol, ALumina, Stearic Acid, Phenoxyethanol, Potassium Sorbate, Sodium Dehydroacetate, Methicone, Hexylene Glycol, Propanediol, Tocopheryl Acetate, Hydrogen Dimethicone, Boerhavia Diffusa Root Extract, Ascorbyl Palmitate.
    MAY CONTAIN: Iron Oxides (CI 77491, CI 77492, CI77499), Titanium Dioxide (CI77891).

  • Other information

    • protect this product from excessive heat and direct sun
  • QUESTIONS OR COMMENTS?

    CALL TOLL FREE 1-866-983-8582

  • PRINCIPAL DISPLAY PANEL

    LBL_sunscreen

    Sunscreen DF box

  • INGREDIENTS AND APPEARANCE
    ULTA BEAUTY TINTED MOISTURIZER  SPF-30
    octinoxate, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62296-0118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    BOERHAVIA DIFFUSA ROOT (UNII: KR0SR09KYL)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62296-0118-135 mL in 1 TUBE; Type 0: Not a Combination Product09/27/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/17/2015
    Labeler - Ulta (608168597)