SUNSCREEN SPF 30 CAREONE (AVOBENZONE 3% HOMOSALATE 10% OCTISALATE 5% OCTOCRYLENE 2% OXYBENZONE 4%) SPRAY [CAREONE]

SUNSCREEN SPF 30 CAREONE (AVOBENZONE 3% HOMOSALATE 10% OCTISALATE 5% OCTOCRYLENE 2% OXYBENZONE 4%) SPRAY [CAREONE]
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NDC 41520-360-05
Set ID 54339206-8a48-4757-8bde-6b83333410d2
Category HUMAN OTC DRUG LABEL
Packager CareOne
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients                                                                         Purpose
    Avobenzone 3.0%.........................................................................Sunscreen
    Homosalate 10.0%........................................................................Sunscreen
    Octisalate 5.0%............................................................................Sunscreen
    Octocrylene 2.0%..........................................................................Sunscreen
    Oxybenzone 4.0%.........................................................................Sunscreen

  • PURPOSE

  • INDICATIONS & USAGE

    Uses • helps prevent sunburn • higher SPF gives more sunburn protection

  • WARNINGS

    Warnings
    For external use only
    Flammable: Do not use near heat, flame, or while smoking.
    Do not use on damaged or broken skin
    When using this product • Keep out of eyes. Rinse eyes with water to remove.
    • Keep away from face to avoid breathing it • Do not puncture or incinerate. Contents under
    pressure. Do not store at temperatures above 120ºF.
    Stop use and ask a doctor if rash occurs

  • KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    Directions
    • Spray liberally and spread evenly by hand 15 minutes before sun exposure • Reapply: •
    after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2
    hours • 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 • 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 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

  • OTHER SAFETY INFORMATION

    Other information • protect this product from excessive heat and direct sun. • may stain fabrics.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Acrylates/Octylacrylamide Copolymer,
    Alcohol Denat., Caprylic/Capric Triglyceride, Diethylhexyl
    Syringylidenemalonate, Fragrance, Glycerin, Retinyl Palmitate,
    Stearoxytrimethylsilane, Tocopherol.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN SPF 30  CAREONE
    avobenzone 3% homosalate 10% octisalate 5% octocrylene 2% oxybenzone 4% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-360
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 g
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate10 g  in 100 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 g
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene2 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248)  
    Glycerin (UNII: PDC6A3C0OX)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Stearoxytrimethylsilane (UNII: 9862TW94B2)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-360-05153 g in 1 CAN; Type 0: Not a Combination Product04/13/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/13/2018
    Labeler - CareOne (809183973)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(41520-360) , label(41520-360)

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