Label: AVEENO BABY DAILY CARE SET- dimethicone kit

  • NDC Code(s): 69968-0441-2, 69968-0592-1
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 6, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Dimethicone 1.2%

  • Purpose

    Skin Protectant

  • Uses

    • Helps prevent and temporarily protects chafed, chapped or cracked skin
  • Warnings

    For external use only

    When using this product

    • Do not get into eyes

    Stop use and ask a doctor if

    • Condition worsens
    • Symptoms last more than 7 days or clear up and occur again within a few days

    Do not use on

    • Deep or puncture wounds
    • Animal bites
    • Serious burns

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply as needed.
  • Other information

    • Remove quality seal. Do not use if quality seal is broken.
    • Store at room temperature.
  • Inactive ingredients

    Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Sodium Chloride, Allantoin

  • 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 - Kit Container

    Aveeno
    Baby ®

    daily care set

    trusted daily nourishment
    for baby's skin

    Cleanse Gently
    12 FL. OZ. (354 mL)

    Soothe and Moisturize
    12 FL. OZ. (354 mL)

    PRINCIPAL DISPLAY PANEL - Kit Container
  • INGREDIENTS AND APPEARANCE
    AVEENO BABY DAILY CARE SET 
    dimethicone kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0592
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0592-11 in 1 CONTAINER11/01/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PUMP 354 mL
    Part 21 BOTTLE 354 mL
    Part 1 of 2
    AVEENO BABY DAILY MOISTURE 
    dimethicone lotion
    Product Information
    Item Code (Source)NDC:69968-0441
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE12 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    OATMEAL (UNII: 8PI54V663Y)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0441-2354 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/01/2001
    Part 2 of 2
    AVEENO BABY WASH AND SHAMPOO 
    baby shampoos solution
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRSODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRCOCO GLUCOSIDE (UNII: ICS790225B)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRGLYCERYL OLEATE (UNII: 4PC054V79P)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRGUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGROAT (UNII: Z6J799EAJK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1354 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic03/25/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/01/2019
    Labeler - Johnson & Johnson Consumer Inc. (118772437)