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 July 25, 2023

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  • Active Ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

  • 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, diethylhexyl 2, 6-naphthalate, silica, butyloctyl salicylate, caprylyl methicone, dimethicone, potassium cetyl phosphate, benzyl alcohol, beeswax, glyceryl stearate, PEG-100 stearate, cetyl dimethicone, glycerin, behenyl alcohol, sodium polyacrylate, acrylates/C12-22 alkyl methacrylate copolymer, xanthan gum, chlorphenesin, dimethicone/PEG-10/15 crosspolymer, ethylhexyl stearate, fragrance, disodium EDTA, tocopheryl acetate, BHT, trideceth-6, pentylene glycol, benzyl benzoate

  • SPL UNCLASSIFIED SECTION

    May stain or damage some fabrics or surfaces.

    DISTRIBUTED BY:

    RITE AID

    200 NEWBERRY COMMONS

    ETTERS, PA 17319

    www.riteaid.com

    SATISFACTION GUARANTEE:

    If you're not satisifed, We'll happily refund your money.

    This product is not manufacturedor distributed by Johnson & Johnson Corporation., distributor of Neutrogena Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 30.

  • Principal display panel

    SHEER TOUCH

    SUNSCREEN

    SUNSCREEN LOTION

    30

    BROAD SPECTRUM SPF 30

    WATER RESISTANT

    RYSHI

    WATER RESISTANT

    (80 MINUTES)

    QUICKLY ABSORBS

    COMPARE TO NEUTROGENA® ULTRA SHEER® SUNSCREEN*

    3 FL OZ (88 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    AVOBENZONE, HOMOSALATE, OCTISALATE 
    avobenzone, homosalate, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-9832
    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) Homosalate100 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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-9832-188 mL in 1 TUBE; Type 0: Not a Combination Product07/25/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/25/2023
    Labeler - Rite Aid (014578892)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(11822-9832)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(11822-9832)
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