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

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

ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.]
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NDC 58443-0127-4
Set ID 800910f0-4d44-48fc-af6b-7c5e6df0cf88
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

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Fragrance (Parfum), Hydroxypropyl Methylcellulose, Methylisothiazolinone, Methylparaben, Polyethylene, Polysorbate 20, Propylene Glycol, Propylparaben, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

  • Other information

    • protect from excesive heat & direct sunlight
  • QUESTIONS

  • 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 (177mL)

  • INGREDIENTS AND APPEARANCE
    ULTA  SPF 15 LIGHT MEDIUM BROAD SPECTRUM
    avobenzone, octisalate, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0127
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE19 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47.5 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE23.75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    2,6-DI-TERT-BUTYL-4-((METHYLTHIO)METHYL)PHENOL (UNII: 650986R470)  
    N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
    ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CARAMEL (UNII: T9D99G2B1R)  
    CETEARETH-22 (UNII: 28VZG1E234)  
    DIHYDROXYACETONE (UNII: O10DDW6JOO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    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
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0127-4177 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2008
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0127) , pack(58443-0127) , manufacture(58443-0127) , analysis(58443-0127)
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