Label: SUNSCREEN- avobenzone, homosalatem, octisalate, octocrylene lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 7, 2020

If you are a consumer or patient please visit this version.

  • active ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 4.5%

    Octocrylene 8%

  • 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
  • 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 right away.

  • Directions

    • apply liberaly 15 minutes before sun exposure
    • apply to all skin exposed to the sun
    • 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 value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especialy 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 in this container from excessive heat and direct sun
  • inactive ingredients

    water, aluminum starch octenylsuccinate, styrene/acrylates copolymer, glycerin, polyester-7, silica, chlorphenesin, arachidyl alcohol, beeswax, benzyl alcohol, neopentyl glycol diheptanoate, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol, arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate, fragrance

  • claims

    This product is not manufactured or distributed by Bayer, distributor of Coppertone Sunscreen Lotion Spectrum SPF 50

    Oxybenzone & Octinoxate Free

    May stain or damage some fabrics or surfaces

  • Adverse reactions section

    DISTRIBUTED BY DOLGENCORP, LLC

    100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

    924.000/924AA

  • principal display panel

    STUDIO

    SELECTION

    SUN

    SPORT

    SUNSCREEN

    LOTION

    BROAD SPECTRUM

    SPF 50

    Compare to Coppertone Sport Broad Spectrum SPF 50

    SPF 50

    • Water-Resistant (80 minutes)

    SWEAT-RESISTANT

    FORMULA

    8 FL OZ (236 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    avobenzone, homosalatem, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-924
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE90 mg  in 1 mL
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate1000 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE202.5 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE640 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYESTER-7 (UNII: 0841698D2F)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    arachidyl glucoside (UNII: 6JVW35JOOJ)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-924-34236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/08/2019
    Labeler - Dolgencorp, LLC (068331990)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(55910-924)