URBAN OUTFITTERS SUNSCREEN SHIMMER BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]

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  • URBAN OUTFITTERS SUNSCREEN SHIMMER BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]

URBAN OUTFITTERS SUNSCREEN SHIMMER BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]
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NDC 58443-0259-4
Set ID 6804515c-d582-1563-e053-2991aa0ad9dd
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 3%

    Homosalate 7.5%

    Octisalate 5%

    Octocrylene 2.75%

    Oxybenzone 2%

  • 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 and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and 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, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Hydroxypropyl Methylcellulose, Isopropylphthalimide ,Mangifera Indica (Mango) Seed Butter, Mica, Phenoxyethanol, Polyester-8, Polyethylene, Polysorbate 20, Propylene Glycol, Silk Amino Acids, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Titanium Dioxide, Tocopheryl Acetate, Water

  • Other information

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

    Call toll free 1-800-282-2200

  • Urban Outfitters Sunscreen Shimmer Lotion 30 Broad Spectrum SPF 30

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    URBAN OUTFITTERS  SUNSCREEN SHIMMER BROAD SPECTRUM SPF 30
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0259
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE20.2 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.3 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50.5 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27.78 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE75.75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINO ACIDS, SILK (UNII: V0L00EX1IA)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALLANTOIN (UNII: 344S277G0Z)  
    N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
    MICA (UNII: V8A1AW0880)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (Off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0259-4177 mL in 1 TUBE; Type 0: Not a Combination Product03/02/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/02/2018
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0259) , manufacture(58443-0259) , label(58443-0259) , analysis(58443-0259)
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