ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]

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  • ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]

ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]
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NDC 58443-0126-4
Set ID 96cf7bfd-56f1-4dce-b475-7aa284ab0f4c
Category HUMAN OTC DRUG LABEL
Packager Prime Enterprises, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active Ingredients

    Octinoxate 5%, Octisalate 3 %, and Oxybenzone 2 %

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings

    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 only to prevent sunburn, not skin cancer or early skin aging.

    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 hour              
    • children under  6 months: Ask a doctor
  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Ammonium Hydroxide, Butylphthalimide, C12-15 Alkyl Benzoate, Carrageenan, Citric Acid, Diazolidinyl Urea, Disodium EDTA, Glyceryl Stearate, Isopropyl Myristate, Isopropylphthalimide, Magnesium Aluminum Silicate, Methylparaben, Polyethylene, Propylparaben, Soluble Collagen, Sorbitol, Stearic Acid, Stearyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water

  • Other information

    • protect this product from excesive heat and direct sun
  • Questions or Comments?:

     Call- 1-866-983-8582

  • PRINCIPAL DISPLAY PANEL - 177 mL  Tube Label

    PRINCIPAL DISPLAY PANEL - 177 mL Tube Label


    ULTA

    OIL-FREE

    SUNSCREEN

    LOTION

    SPF

    15

    SUN

    WATER RESISTANT (80 MINUTES)

    NON-GREASY FORMULA

    6 FL.OZ./177mL

  • INGREDIENTS AND APPEARANCE
    ULTA  SUNSCREEN SPF 15
    octinoxate, octisalate, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0126
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE27.9 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE18.6 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE46.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TETRAETHYLAMMONIUM HYDROXIDE (UNII: RA8VU41B1F)  
    N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
    ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    WATER (UNII: 059QF0KO0R)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0126-4177 mL in 1 TUBE; Type 0: Not a Combination Product03/12/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/12/2007
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0126) , pack(58443-0126) , manufacture(58443-0126) , analysis(58443-0126)
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