Label: AVOBENZONE, HOMOSALATE, OCTISALATE lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 24, 2024

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

  • Adverse event

    *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.

    DISTRIBUTED BY: RITE AID

    200 NEWBERRY COMMONS, ETTERS, PA 17319

    www.riteaid.com

  • Principal display panel

    Comapre to Coppertone® Sunscreen Lotion Sport Broad Spectrum SPF 50*

    SPORT

    WATER RESISTANT

    (80 MINUTES)

    SUNSCREEN LOTION

    BROAD SPECTRUM SPF 50

    UVA/UVB Sunscreen

    Won't run when you start to sweat

    Helps prevent sunburn

    50

    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:11822-9403
    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:11822-9403-4236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/06/2023
    Labeler - Rite Aid Corporation (014578892)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(11822-9403)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091520manufacture(11822-9403)