Label: AVOBENZONE, HOMOSALATE, OCTISALATE 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 August 24, 2023

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

  • Active Ingredients

    Avobenzone 3%

    Homosalate 12%

    Octisalate 5%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protections 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 Center right away

  • Directions

    • apply liberally 15 minutes before sun exposure
    • apply to all skin exposed to the sun
    • reapply:
    • after 80 minutes of swimming or sweating
    • mmediately 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
    • children under 6 months of age: Ask a doctor
  • Other information

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

    water, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, styrene/acrylates copolymer, aluminum starch octenylsuccinate, glycerin, polyester-7, silica, chlorphenesin, benzyl alcohol, arachidyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, neopentyl glycol diheptanoate, behenyl alcohol, tocopherol, beeswax, arachidyl glucoside, potassium hydroxide, glyceryl stearate, PEG-100 stearate, disodium EDTA, sodium ascorbyl phosphate, fragrance, amyl cinnamal

  • Disclaimer

    *This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone® Sunscreen Lotion Sport Broad Spectrum SPF 50.

    May stain or damage some fabrics or surfaces.

  • Adverse Reaction

    DISTRIBUTED BY OLD EAST MAIN CO.

    100 MISSION RIDGE 

    GOODLETTSVILLA, TN 37072

    100% Satisfaction Guaranteed!

    (888)309-9030

  • 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
    AVOBENZONE, HOMOSALATE, OCTISALATE 
    avobenzone, homosalate, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75712-940
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE120 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYESTER-7 (UNII: 0841698D2F)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75712-940-34236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/24/2023
    Labeler - Old East Main Co. (006946172)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(75712-940)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(75712-940)