ULTA BROAD SPECTRUM SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]

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  • ULTA BROAD SPECTRUM SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]

ULTA BROAD SPECTRUM SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]
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NDC 13630-0044-4
Set ID 2eaa3aee-503f-4217-be81-c5a1331471e8
Category HUMAN OTC DRUG LABEL
Packager Prime Packaging, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active ingredients

    Avobenzone 3 %, Homosalate 12.5 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 6 %

  • PURPOSE

    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 0F

    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 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 well-ventilated areas.
    • 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/Octylacrylamide Copolymer, Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Polyester-8, SD Alcohol 40-B

  • Other information

    • protect this product from excesive heat and direct sun
    • avoid spraying on fabrics - could cause discoloration
  • QUESTIONS

    Questions or Comments?

    Call toll free 1-800-983-8582

  • PRINCIPAL DISPLAY PANEL - 177 mL Can Label

    PRINCIPAL DISPLAY PANEL - 177 mL Can Label

    ULTA

    OIL-FREE

    SUNSCREEN

    CONTINUOUS SPRAY

    BROAD SPECTRUM SPF 70

    WATER RESISTANT (80 MINUTES)

    NON-GREASY FORMULA

    SUN

    6 FL. OZ./177 mL

  • INGREDIENTS AND APPEARANCE
    ULTA  BROAD SPECTRUM SPF 70
    avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0044
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25.9 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE108.1 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE43.3 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE23.8 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE51.9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0044-4177 mL in 1 CAN; 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 Packaging, Inc. (805987059)
    Registrant - Prime Packaging, Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(13630-0044) , analysis(13630-0044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging, Inc.805987059label(13630-0044) , pack(13630-0044)
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