SUNSCREEN SPF 70 (AVOBENZONE 3% HOMOSALATE 15% OCTISALATE 5% OCTOCRYLENE 10% OXYBENZONE 6%) SPRAY [CARE ONE]

SUNSCREEN SPF 70 (AVOBENZONE 3% HOMOSALATE 15% OCTISALATE 5% OCTOCRYLENE 10% OXYBENZONE 6%) SPRAY [CARE ONE]
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NDC 41520-338-05
Set ID 0699e262-6ffd-45d9-9896-be5ea1c83819
Category HUMAN OTC DRUG LABEL
Packager Care One
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients                                                                              Purpose
    Avobenzone 3%.................................................................................Sunscreen
    Homosalate 15%................................................................................Sunscreen
    Octisalate 5%....................................................................................Sunscreen
    Octocrylene 10%...............................................................................Sunscreen
    Oxybenzone 6%.................................................................................Sunscreen

  • PURPOSE

  • INDICATIONS & USAGE

    Uses • helps prevent sunburn • higher SPF gives more sunburn protection
    • retains SPF after 80 minutes of activity in the water or sweating • provides
    moderate protection against sunburn

  • WARNINGS

    Warnings
    Flammable: Do not use near heat, flame, or while smoking.
    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 or irritation develops and last.
    Keep out of reach of children. If product is swallowed, get medical help or
    contact a Poison Control Center right away.
    Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate.
    Do not store at temperature above 120°F

  • KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    Directions

    • Apply liberally 15 minutes before sun exposure and as
    needed. • Children under 6 months of age: ask a doctor. • 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 a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses. • 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. • For sunscreen use: • apply to all skin exposed to the
    sun. • Reapply as needed or after towel drying, swimming, or sweating.

  • OTHER SAFETY INFORMATION

    Other information • protect the product in this container 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.

  • Questions? 1-877-846-9949

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN SPF 70 
    avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% oxybenzone 6% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-338
    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) Homosalate15 g  in 100 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 g
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene10 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-338-05160 g in 1 CAN; Type 0: Not a Combination Product01/18/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/18/2013
    Labeler - Care One (809183973)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(41520-338) , label(41520-338)

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