Label: SUNSCREEN- avobenzone, homosalate, 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 April 5, 2022

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  • active ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

    Octocrylene 6%

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

  • Adverse reactions section

    May stain or damage some favrics or surfaces

    *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Neutrogena Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 30.

    **Ozybenzone & Octinoxate free

    Questions 1-888-593-0593

    DISTRIBUTED BY MEIJER

    DISTRIBUTION, INC.

    GRAND RAPIDS, MI 49544

    www.meijer.com

  • principal display panel

    Compare to Neutrogena Ultra Sheer Sunscreen Broad Spectrum SPF 30*

    meijer

    sheer

    touch

    SUNSCREEN

    LOTION

    Broad Spectrum SPF 30

    WATER RESISTANT

    (80 MINUTES)

    Clean, Lightweight feel

    Dermatologist teste

    Quickly absorbs

    Non-greasy

    REEF FRIENDLY

    3 FL OZ (88 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-0914
    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) OCTISALATE250 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE360 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    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)  
    DIMETHICONE PEG-10 PHOSPHATE (UNII: O7Q5NJ7X88)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    xanthan gum (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ALLYL METHACRYLATE (UNII: G2IG50653Z)  
    ethylhexyl stearate (UNII: EG3PA2K3K5)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    diethylhexyl 2,6-naphthalate (UNII: I0DQJ7YGXM)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-0914-289 mL in 1 TUBE; Type 0: Not a Combination Product03/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/15/2021
    Labeler - Meijer (006959555)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(79481-0914)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(79481-0914)
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