Label: AVEENO PROTECT PLUS HYDRATE SUNSCREEN BROAD SPECTRUM BODY SPF 30- avobenzone, homosalate, octisalate, and octocrylene lotion

  • NDC Code(s): 69968-0667-1, 69968-0667-3
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 19, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Avobenzone 1.5%Sunscreen
    Homosalate 5%Sunscreen
    Octisalate 4%Sunscreen
    Octocrylene 6%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 liberally 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, Glycerin, Diisopropyl Adipate, Alcohol Denat., Caprylyl Methicone, Dimethicone, Silica, Dicaprylyl Carbonate, Sodium Acryloyldimethyltaurate/VP Crosspolymer, Polyurethane-62, Hydroxyacetophenone, Pentylene Glycol, Acrylates/Dimethicone Copolymer, Glyceryl Stearate, Phenoxyethanol, Chlorphenesin, Dimethicone Crosspolymer, Fragrance, Disodium EDTA, Trideceth-6, Avena Sativa (Oat) Kernel Extract, Sodium Hydroxide

  • Questions?

    866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 88 mL Tube Label

    NEW
    LIGHTWEIGHT
    FORMULA

    DERMATOLOGIST
    RECOMMENDED

    Aveeno ®

    PROTECT+
    HYDRATE

    sunscreen

    BROAD-SPECTRUM
    UVA+UVB PROTECTION

    all-day hydration
    with prebiotic oat

    oxybenzone free

    sweat + water resistant
    (80 min)

    SPF
    30

    3.0 FL OZ (88mL)

    PRINCIPAL DISPLAY PANEL - 88 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    AVEENO PROTECT PLUS HYDRATE SUNSCREEN BROAD SPECTRUM BODY SPF 30 
    avobenzone, homosalate, octisalate, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0667
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE15 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE50 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    ALCOHOL (UNII: 3K9958V90M)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    OAT (UNII: Z6J799EAJK)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0667-380 mL in 1 TUBE; Type 0: Not a Combination Product10/01/202001/23/2021
    2NDC:69968-0667-188 mL in 1 TUBE; Type 0: Not a Combination Product10/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/01/2020
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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