Label: AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE lotion

  • NDC Code(s): 72476-950-34
  • Packager: RETAIL BUSINESS SERVICES, LLC
  • 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 20, 2023

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  • 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 rist of skin cancer and early skin aging caused by the sun
  • Warnings

    For external use only

  • Do not use

    • on damaged or broken skin
  • 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 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 rist, 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, glycerin, aluminum starch octenylsuccinate, styrene/acrylates copolymer, behenyl alcohol, glyceryl stearate, benzyl alcohol, PEG-100 stearate, polyester-7, tocopherol, arachidyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, arachidyl glucoside, chlorphenesin, beeswax, silica, neopentyl glycol diheptanoate, potassium hydroxide, disodium EDTA

  • SPL UNCLASSIFIED SECTION

    May stain or damage some fabrics or surfaces

    Dist by Foodhold USA, LLC Landover, MD 20733  1877-846-9949

    (c)2019 S&S Brands, LLC Quality guaranteed or your money back

    *This product is not manufactured or distributed by Bayer, distributor of Coppertone Sunscreen Lotion Water Babies Pure & Simple Broad spectrum SPF 50

    **Oxybenzone & Octinoxate free

  • Principal display panel

    CareOne

    Compare to Coppertine Sunscreen Lotion Water Babies SPF 50*

    Baby Sunscreen Lotion

    SPF 50 UVA/UVB protection

    Broad Spectrum SPF 50

    Water resistant (80 minutes)

    Reef friendly

    8 FL OZ (236 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-950
    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) OCTISALATE45 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYESTER-7 (UNII: 0841698D2F)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    neopentyl glycol diheptanoate (UNII: 5LKW3C543X)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-950-34236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/08/2019
    Labeler - RETAIL BUSINESS SERVICES, LLC (967989935)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(72476-950)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(72476-950)
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