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

URBAN OUTFITTERS BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING INC.]
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NDC 13630-0128-4
Set ID 681a5509-91e3-914c-e053-2991aa0ae99d
Category HUMAN OTC DRUG LABEL
Packager Prime Packaging Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • 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. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F.

    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.

    Flammable: Do not use near heat, flame or while smoking.

  • Directions

    • spray liberally and spread evenly by hand 15 minutes before sun exposure
    • hold container 4 to 6 inches from the skin to apply
    • do not spray directly into face. Spray on hands then apply to face
    • do not apply in windy conditions
    • use in a well-ventilated area
    • reapply:
    • after 80 minutes of swimming and 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 snscreen with a 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/Dimethicone Copolymer, Aloe Barbadensis Leaf Juice, Camellia Oleifera (Green Tea) Leaf Extract, Cyclopentasiloxane, Fragrance, Glycerin, Polyester-8, SD Alcohol 40 B, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water

  • Other information

    • protect this product from excessive heat and direct sun
    • avoid spraying on fabrics - could cause discoloration.
  • Question or comments?

    Call toll free 1-800-282-2200

  • Urban Outfitters Sunscreen Continuous Spray 30 Broad Spectrum

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    URBAN OUTFITTERS  BROAD SPECTRUM SPF 30 SUNSCREEN
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0128
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25.2 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE42 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE23.1 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE16.8 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE63 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ACRYLAMIDE (UNII: 20R035KLCI)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
    VINYL ACETATE (UNII: L9MK238N77)  
    DIBUTYL MALEATE (UNII: 4X371TMK9K)  
    Product Characteristics
    Coloryellow (Colorless to pale yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0128-4177 mL in 1 CAN; Type 0: Not a Combination Product02/12/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/12/2018
    Labeler - Prime Packaging Inc. (805987059)
    Registrant - Prime Packaging Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc101946028manufacture(13630-0128) , analysis(13630-0128)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging Inc.805987059pack(13630-0128) , label(13630-0128)

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