ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]

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  • ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]

ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]
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NDC 58443-0130-4
Set ID 2c9d911e-9084-471f-9c13-99d109b7b575
Category HUMAN OTC DRUG LABEL
Packager Prime Enterprises, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active Ingredients

    Avobezone 3%, Ensulizole 1 %. Homosalate 15 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 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 hour      

    • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher & 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: Ask a doctor

  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Aluminum Starch Octenylsuccinate, Butylphthalimide, c12-15 Alkyl Benzoate, Carrageenan, Citric Acid, Diethylhexyl 2,6-Naphthalate, Disodium EDTA, Glyceryl Stearate, Isopropylphthalimide, Methylisothiazolinone, Polyester-8, Polyethylene, 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 - 148 mL  Tube Label

    PRINCIPAL DISPLAY PANEL - 148 mL Tube Label


    ULTA

    DrY TOUCH

    FACES SUNSCREEN

    LOTION

    BROAD

    SPECTRUM

    SPF 80

    WATER RESISTANT (80 MINUTES)

    LIGHTWEIGHT CLEAN FEEL

    FAST ABSORBING

    LEAVES SKIN SOFT + SMOOTH

    SUNFACES

    5FL. OZ. / 148 mL

  • INGREDIENTS AND APPEARANCE
    ULTA  BROAD SPECTRUM SUNSCREEN SPF80
    avobezone, enzulizole, homosalate, octisalate, octocrylene, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0130
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE28.2 mg  in 1 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE9.4 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE141 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE25.85 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE37.6 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)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIETHYL (6-CHLORO-2-CARBAZOLYL)METHYLMALONATE (UNII: 74I9HB1BX3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    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:58443-0130-4148 mL in 1 TUBE; Type 0: Not a Combination Product12/01/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2008
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0130) , pack(58443-0130) , manufacture(58443-0130) , analysis(58443-0130)
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