Label: AVEENO POSITIVELY MINERAL SENSITIVE SKIN SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion

  • NDC Code(s): 69968-0395-1, 69968-0395-3
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 May 24, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    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 generously and evenly 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, C12-15 Alkyl Benzoate, Dimethicone, Glycerin, Phenoxyethanol, Phenyl Trimethicone, Styrene/Acrylates copolymer, Octyl dodecyl Citrate Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Polyhydroxystearic acid, Silica, Ethyl methicone,Cetyl Dimethicone, Triethoxycaprylylsilane, 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?

    886-428-3366; 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

    DERMATOLOGIST
     RECOMMENDED

    Aveeno ®
    POSITIVELY
    MINERAL™

    sensitive skin
    sunscreen

    BROAD SPECTRUM SPF 50

    naturally-sourced
    100% zinc oxide
    active ingredient
    sweat + water resistant
    (80 min)

    SPF

    50

    3.0 fl. oz (88 mL)

    PRINCIPAL DISPLAY PANEL - 88 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    AVEENO POSITIVELY MINERAL SENSITIVE SKIN SUNSCREEN BROAD SPECTRUM SPF 50 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0395
    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)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
    OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ETHYL METHICONE (8 MPA.S) (UNII: 3YWG8XYT8H)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    OATMEAL (UNII: 8PI54V663Y)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMER (UNII: AE7QA6TW0Q)  
    FEVERFEW (UNII: Z64FK7P217)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0395-388 mL in 1 TUBE; Type 0: Not a Combination Product10/01/201811/27/2024
    2NDC:69968-0395-114 mL in 1 TUBE; Type 0: Not a Combination Product10/01/201801/12/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/201811/27/2024
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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