Label: AVEENO BABY CONTINUOUS PROTECTION SENSITIVE SKIN SUNSCREEN BROAD SPECTRUM SPF50- zinc oxide lotion

  • NDC Code(s): 69968-0304-1, 69968-0304-3, 69968-0304-6, 69968-0304-7
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 18, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Zinc Oxide 21.6%

  • 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 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 value of SPF 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, C 12-15 Alkyl Benzoate, Styrene/Acrylates Copolymer, Octyldodecyl Citrate Crosspolymer, Phenyl Trimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Polyhydroxystearic Acid, Glycerin, Ethyl Methicone, Silica, Cetyl Dimethicone, Triethoxycaprylylsilane, Phenoxyethanol, Glyceryl Behenate, Sodium Chloride, Acrylates/Dimethicone Copolymer, Chlorphenesin, Phenethyl Alcohol, Avena Sativa (Oat) Kernel Flour, Caprylyl Glycol, Cetyl Dimethicone/Bis-Vinyldimethicone Crosspolymer, Chrysanthemum Parthenium (Feverfew)Flower/Leaf/Stem Juice

  • 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 - 207 mL Tube Label

    PEDIATRICIAN
    RECOMMENDED BRAND
    Aveeno
    Baby ®
    CONTINUOUS
    PROTECTION ®
    sensitive skin
    zinc oxide
    sunscreen
    BROAD SPECTRUM SPF 50
    naturally-sourced 100%
    mineral active ingredient
    sweat + water resistant
    (80 min)
    SPF
    50
    7.0 fl oz (mL)

    Principal Display Panel - 207 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    AVEENO BABY CONTINUOUS PROTECTION SENSITIVE SKIN  SUNSCREEN BROAD SPECTRUM SPF50
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0304
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE216 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYL METHICONE (8 MPA.S) (UNII: 3YWG8XYT8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    OATMEAL (UNII: 8PI54V663Y)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FEVERFEW (UNII: Z64FK7P217)  
    BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
    OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M)  
    CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMER (UNII: AE7QA6TW0Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0304-114 mL in 1 TUBE; Type 0: Not a Combination Product10/01/201602/28/2024
    2NDC:69968-0304-388 mL in 1 TUBE; Type 0: Not a Combination Product10/01/2016
    3NDC:69968-0304-62 in 1 TRAY11/20/201901/23/2025
    3NDC:69968-0304-388 mL in 1 TUBE; Type 0: Not a Combination Product
    4NDC:69968-0304-7207 mL in 1 TUBE; Type 0: Not a Combination Product12/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/01/2016
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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