Label: NEUTROGENA BEACH DEFENSE WATER PLUS SUN PROTECTION SUNSCREEN BROAD SPECTRUM SPF50- avobenzone, homosalate, octisalate, and octocrylene lotion

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

Drug Label Information

Updated November 12, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Avobenzone 3%Sunscreen
    Homosalate 15%Sunscreen
    Octisalate 5%%Sunscreen
    Octocrylene 10%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 Center right away.
  • Directions

    • apply generously 15 minutes before sun exposure
    • 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 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 this product from excessive heat and direct sun
    • may stain some fabrics
  • Inactive ingredients

    Water, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Potassium Cetyl Phosphate, Benzyl Alcohol, Silica, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Caprylyl Glycol, Synthetic Beeswax, Ethylhexylglycerin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Behenyl Alcohol, Fragrance, Xanthan Gum, Chlorphenesin, Dimethicone/PEG-10/15 Crosspolymer, Hydrolyzed Jojoba Esters, Disodium EDTA, Sodium Polyacrylate, Ethylhexyl Stearate, BHT, Jojoba Esters, Trideceth-6

  • Questions or Comments?

    Call toll-free 800-299-4786 or 215-273-8755 (collect). www.neutrogena.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    JOHNSON & JOHNSON CONSUMER INC.
    Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 198 mL Bottle Label

    Neutrogena ®

    DERMATOLOGIST RECOMMENDED BRAND

    Beach

    Defense ®

    water + sun

    protection

    sunscreen lotion

    BROAD SPECTRUM SPF 50

    50

    helioplex ®

    broad spectrum uva●uvb

    oxybenzone free

    water resistant (80 minutes)

    6.5 FL OZ (198 mL)

    Ntg-001

  • INGREDIENTS AND APPEARANCE
    NEUTROGENA BEACH DEFENSE WATER PLUS SUN PROTECTION SUNSCREEN BROAD SPECTRUM SPF50 
    avobenzone, homosalate, octisalate, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0599
    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) HOMOSALATE150 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0599-7198 mL in 1 BOTTLE; Type 0: Not a Combination Product10/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/07/2019
    Labeler - Kenvue Brands LLC (118772437)
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