ULTA BROAD SPECTRUM SPF 15 MEDIUM DEEP (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.]

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  • ULTA BROAD SPECTRUM SPF 15 MEDIUM DEEP (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.]

ULTA BROAD SPECTRUM SPF 15 MEDIUM DEEP (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.]
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NDC 58443-0128-4
Set ID fe05649d-5b1e-480c-b9c5-befd0ea5278e
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 2.5%

  • 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

    Aloe Barbadensis Leaf Juice, BHT, Butylphthalimide, Calendula Officinalis Flower Extract, Caramel, Ceteareth-20, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Dihydroxyacetone, Dimethicone, Disodium EDTA, Erythrulose, Fragrance, Glycerin, Glyceryl Dilaurate, Isopropylphthalmide, Methylparaben, Mineral Oil, Petrolatum, Phenoxyethanol, Propylene Glycol, Propylparaben, Stearyl Alcohol, Tocopheryl Acetate, Water

  • Other information

    • protect from excesive 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

    ULTA

    TINTED

    SELF-TANNING

    SUNSCREEN LOTION

    BROAD

    SPECTRUM

    SPF 15

    LIGHT

    MEDIUM

    NON-GREASY FORMULA

    INSTANT, HEALTHY GLOW

    BRONZE

    6 FL OZ. /177 mL

  • INGREDIENTS AND APPEARANCE
    ULTA  BROAD SPECTRUM SPF 15 MEDIUM DEEP
    avobenzone, octisalate, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0128
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE19.2 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE48 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE24 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
    ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CARAMEL (UNII: T9D99G2B1R)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIHYDROXYACETONE (UNII: O10DDW6JOO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    L-ERYTHRULOSE (UNII: WKK1W5B83O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0128-4177 mL in 1 TUBE; Type 0: Not a Combination Product11/26/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/26/2008
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0128) , pack(58443-0128) , manufacture(58443-0128) , analysis(58443-0128)
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