Label: AVEENO PROTECT PLUS SOOTHE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide lotion

  • NDC Code(s): 69968-0771-1, 69968-0771-3
  • 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 January 9, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Titanium Dioxide (6.5%)Sunscreen
    Zinc Oxide (18.7%)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, Isohexadecane, C12-15 Alkyl Benzoate, Ethylhexyl methoxycrylene, Behenyl Alcohol, Steareth-21, Glyceryl Stearate, PEG-100 Stearate, Calcium Aluminum Borosilicate, Euphorbia Cerifera (Candelilla) Wax, Polyhydroxystearic Acid, Cetyl Alcohol, Triethoxycaprylylsilane, Aluminum Hydroxide, Xanthan Gum, Stearic Acid, Phenoxyethanol, Ethylhexylglycerin, Glycerin, Chlorphenesin, Tocopheryl Acetate, Disodium EDTA, Aloe Barbadensis Leaf Extract, Avena Sativa (Oat) Kernel Extract

  • 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!

    Aveeno®

    DERMATOLOGIST RECOMMENDED BRAND

    SOOTHING OAT

    Protect +

    Soothe

    MINERAL

    SUNSCREEN

    Broad Spectrum SPF 30

    SENSITIVE SKIN

    Naturally-sourced

    100% mineral actives

    Water resistant (80 minutes)

    SPF

    30

    3.0 fl. OZ (88 mL)

    Aveeno_01

  • INGREDIENTS AND APPEARANCE
    AVEENO PROTECT PLUS SOOTHE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0771
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE65 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE187 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    STEARETH-21 (UNII: 53J3F32P58)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    OAT (UNII: Z6J799EAJK)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0771-112 in 1 PACKAGE10/04/2022
    114 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69968-0771-388 mL in 1 TUBE; Type 0: Not a Combination Product10/04/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/04/2022
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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