SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [THE KROGER CO]

SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [THE KROGER CO]
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NDC 30142-711-34
Set ID 470274a8-2387-4564-be2e-962cb5c7978c
Category HUMAN OTC DRUG LABEL
Packager The Kroger Co
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Avobenzone 3%

    Homosalate 13%

    Octisalate 5%

    Octocrylene 7%

    Oxybenzone 4%

  • Purpose

    Sunscreen

  • Use

    • helps prevent sunburn
    • if used as directed with other sun protections measures (see Directions), decreases the rist 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
  • Stop use and ask a doctor if

    • rash occurs
  • Keep out of reach of children

    if swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • apply liberally 15 minutes before sun exposure
    • 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 use a  reqularly 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
    • children under 6 months of age: Ask a doctor
  • Other Information

    • Protect the product from excessive heat and direct sun
  • Inactive ingredients

    water, sorbitol, triethanolamine, VP/eicosene copolymer, stearic acid, sorbitan isostearate, aluminum starch octenylsuccinate, benzyl alcohol, dimethicone, tocopheryl, chlorphenesin, polyglyceryl-3 distearate, fragrance, carbomer, disodium EDTA

  • Questions or comments?

    1-800-632-6900

  • Adverse Reaction

    DISTRIBUTED BY THE KROGER CO.
    CINCINNATI, OHIO 45202

    711.001/711AB rev 1

  • Disclaimer

    COPPERTONE AND COPPERTONE ULTRA GUARD ARE REGISTERED TRADEMARKS OF BAYER, WHIPPANY, NJ 07981.  BAYER IS NOT AFFILIATED WITH THE KROGER CO. OR THIS PRODUCT

    May stain or damage some fabrics or surfaces.

    QUALITY GUARANTEE

    800-632-6900

    www.kroger.com

  • principal display panel

    compare to COPPERTONE

    ULTRA GUARD see back panel

    Kroger

    SUNSCREEN

    LOTION

    BROAD SPECTRUM SPF 50

    UVA/UVB sunscreen

    hypoallergenic

    water resistant (80 minutes)

    enriched with moisturizers

    non-greasy

    SPF

    50

    8 FL OZ (236 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-711
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.9 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE133.9 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE51.5 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE72.1 mg  in 1 mL
    oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) oxybenzone41.2   in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-711-34236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/12/2016
    Labeler - The Kroger Co (006999528)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(30142-711)

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