ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]

  • Home
  • ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]

ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]
PDF | XML
NDC 58443-0111-4
Set ID 2bdeedb8-cf2e-4f5a-9f14-2c9334dd8c9e
Category HUMAN OTC DRUG LABEL
Packager Prime Enterprises, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
View All Sections
  • Active Ingredients

    Homosalate 6 %, Octinoxate 7.5 %, Octisalate 5 %, and Oxybenzone 4 %

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases you 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 hours
    • children under  6 months: Ask a doctor
  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Ammonium Hydroxide, Butylphthalimide, Carrageenan, Citric Acid, Diazolidinyl Urea, Disodium EDTA, Glyceryl Stearate, Isopropyl Myristate, Isopropylphthalamide, 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  Bottle Label

    PRINCIPAL DISPLAY PANEL-177mL Bottle Label

    ULTA

    OIL-FREE

    SUNSCREEN

    LOTION

    SPF

    30

    SUN

    WATER RESISTANT (80 MINUTES)

    NON-GREASY FORMULA

    6 FL.OZ./177mL

  • INGREDIENTS AND APPEARANCE
    ULTA  OIL FREE SUNSCREEN SPF30
    homosalate, octinoxate, octisalate, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE57 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE71.25 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47.5 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE38 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMMONIA (UNII: 5138Q19F1X)  
    N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
    ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    MARINE COLLAGEN, SOLUBLE (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)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0111-4177 mL in 1 BOTTLE; Type 0: Not a Combination Product04/23/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/23/2013
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0111) , pack(58443-0111) , manufacture(58443-0111) , analysis(58443-0111)
View All Sections

Related Drugs

Search DailyMed Drugs