ULTA BEAUTY SPF 15 BROAD SPECTRUM SUNSCREEN (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.]

ULTA BEAUTY SPF 15 BROAD SPECTRUM SUNSCREEN (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.]
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NDC 13630-0118-4
Set ID 4831cddf-948f-6df8-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Prime Packaging Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Avobenzone 2%

    Octisalate 5%

    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.

    • 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 INGREDIENT

    Aloe Barbadensis Leaf Juice, Camellia Oleifera (Green Tea) Leaf Extract, Diethylhexyl 2,6-Naphthalate, 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 1-866-983-8582

  • Ulta Beauty SPF 15 Broad Spectrum Sunscreen

    Principal Display Image

  • INGREDIENTS AND APPEARANCE
    ULTA BEAUTY  SPF 15 BROAD SPECTRUM SUNSCREEN
    avobenzone, octisalate, and octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE16.2 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40.5 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15.73 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIBUTYL MALEATE (UNII: 4X371TMK9K)  
    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)  
    DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0118-4177 mL in 1 CAN; Type 0: Not a Combination Product12/29/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/29/2016
    Labeler - Prime Packaging Inc. (805987059)
    Registrant - Prime Packaging Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc101946028manufacture(13630-0118) , analysis(13630-0118)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging Inc.805987059pack(13630-0118) , label(13630-0118)

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