Label: AVEENO BABY BATHTIME SOLUTIONS BABY AND MOMMY GIFT SET- dimethicone kit

  • NDC Code(s): 69968-0441-8, 69968-0593-1, 69968-0679-8
  • 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 ®
    bathtime solutions
    baby & mommy gift set

    FOR BABY
    Wash & Shampoo, 8 fl oz (236 mL)
    Daily Moisture Lotion, 8 oz (227 g)
    CALMING COMFORT ® Bath, 8 fl oz (236 mL)

    FOR MOMMY
    Stress Relief Body Wash, 12 fl oz (354 mL)
    Free Reusable Canvas Box

    PEDIATRICIAN
    Aveeno®
    RECOMMENDED ®

    Naturally Nourishing Solutions for Precious Bathtime Moments

    PRINCIPAL DISPLAY PANEL - Kit Container
  • INGREDIENTS AND APPEARANCE
    AVEENO BABY BATHTIME SOLUTIONS BABY AND MOMMY GIFT SET 
    dimethicone kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0593
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0593-11 in 1 CONTAINER06/16/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 227 mL
    Part 21 BOTTLE 236 mL
    Part 31 BOTTLE 236 mL
    Part 41 BOTTLE 354 mL
    Part 51 TUBE 227 g
    Part 1 of 5
    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:69968-0441-8227 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/01/200106/30/2020
    Part 2 of 5
    AVEENO BABY WASH AND SHAMPOO 
    baby shampoos solution
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRSODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    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)  
    INGROATMEAL (UNII: 8PI54V663Y)  
    INGRWATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1236 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic06/01/2010
    Part 3 of 5
    AVEENO BABY CALMING COMFORT BATH 
    baby shampoos solution
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRSODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    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)  
    INGRPOLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGROATMEAL (UNII: 8PI54V663Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1236 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic06/01/2010
    Part 4 of 5
    AVEENO STRESS RELIEF BODY WASH 
    bath soaps and detergents lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRSODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    INGROATMEAL (UNII: 8PI54V663Y)  
    INGRGUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    INGREDETATE SODIUM (UNII: MP1J8420LU)  
    INGRGLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    INGRQUATERNIUM-15 (UNII: E40U03LEM0)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRMYRISTYL ALCOHOL (UNII: V42034O9PU)  
    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
    Cosmetic06/01/2008
    Part 5 of 5
    AVEENO BABY DAILY MOISTURE 
    dimethicone lotion
    Product Information
    Item Code (Source)NDC:69968-0679
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE12 mg  in 1 g
    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:69968-0679-8227 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/01/2001
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/16/2019
    Labeler - Johnson & Johnson Consumer Inc. (118772437)