ULTA SPF 20 BROAD SPECTRUM WATER RESISTANT SUNSCREN WITH SHIMMER (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.]

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  • ULTA SPF 20 BROAD SPECTRUM WATER RESISTANT SUNSCREN WITH SHIMMER (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.]

ULTA SPF 20 BROAD SPECTRUM WATER RESISTANT SUNSCREN WITH SHIMMER (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.]
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NDC 58443-0134-4
Set ID fb7d612b-286d-4d67-95e1-c4d34598971a
Category HUMAN OTC DRUG LABEL
Packager Prime Enterprises, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active ingredients

    Avobenzone 2%, Octisalate 5%, and Octocrylene 1.85%

  • 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 hours
    • 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, Butylphthalimide, C12-15 Alkyl Benzoate,  Camellia Sinensis (Green Tea) Leaf Extract, Caramel, Carbomer, Disodium EDTA, Fragrance (Parfum), Hydroxypropyl Methycellulose, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Mica, Polyethylene, Polysorbate 20, Propylene Glycol, Propylparaben Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Titanium Dioxide, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

  • Other information

    • protect this product from excessive heat and direct sun
  • Questions or comments?

    Call 1-866-983-8582

  • PRINCIPAL DISPLAY PANEL - 177 mL  Tube Label

    PRINCIPAL DISPLAY PANEL - 177mL Tube Label

    BRONZE GLOW

    BROAD

    SPECTRUM

    SPF 20

    WATER RESISTANT

    (80 MINUTES)

    SUNSCREEN LOTION

    WITH SHIMMER

    ULTA

    6 FL OZ (177mL)

  • INGREDIENTS AND APPEARANCE
    ULTA  SPF 20 BROAD SPECTRUM WATER RESISTANT SUNSCREN WITH SHIMMER
    avobenzone, octisalate, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0134
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE19.6 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE18.13 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
    ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CARAMEL (UNII: T9D99G2B1R)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLCELLULOSE (100 MPA.S) (UNII: 4GFU244C4J)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0134-4177 mL in 1 TUBE; Type 0: Not a Combination Product09/20/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/20/2012
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0134) , pack(58443-0134) , manufacture(58443-0134) , analysis(58443-0134)
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