Label: AVEENO BABY WELCOME LITTLE ONE GIFT BASKET- dimethicone kit

  • NDC Code(s): 69968-0679-8, 69968-0766-9
  • 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

    Aveeno ® baby daily moisture lotion

    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

    • To open, twist off cap and 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 Package

    RECOMMENDED BY

    PEDIATRICIANS

    & DERMATOLOGISTS

    Aveeno®

    baby

    NEW

    Includes

    1oz travel size

    welcome little one

    gift basket

    Everyday gentle essentials to calm, cleanse, and moisturize baby

    Aveeno®

    baby

    Gift basket

    Includes :

    Daily Moisture Wash &

    Shampoo (8 fl oz & 1 fl oz)

    Gently cleanses and

    nourishes baby’s hair

    and sensitive skin

    CALMING COMFORT® Bath

    (8 fl oz)

    Gently cleanses baby’s

    delicate skin and helps

    calm baby before bedtime

    Daily Moisture Lotion

    (8 fl oz)

    Protects and moisturizes

    baby’s sensitive skin for

    24hrs

    Sensitive All Over Wipes

    (64 ct)

    Wipes away dirt and germs

    and contains oat extract and

    aloe

    Aveeno_001

  • INGREDIENTS AND APPEARANCE
    AVEENO BABY WELCOME LITTLE ONE GIFT BASKET 
    dimethicone kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0766
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0766-91 in 1 PACKAGE06/01/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 227 g
    Part 21 BOTTLE 236 mL
    Part 30 BOTTLE 29 mL
    Part 41 BOTTLE 236 mL
    Part 51 PACKET 64 
    Part 1 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
    PETROLATUM (UNII: 4T6H12BN9U)  
    OAT (UNII: Z6J799EAJK)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ALLANTOIN (UNII: 344S277G0Z)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    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 finalpart34708/01/2011
    Part 2 of 5
    AVEENO BABY DAILY MOISTURE 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 MONOOLEATE (UNII: C4YAD5F5G6)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRGUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    INGROAT (UNII: Z6J799EAJK)  
    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
    Cosmetic07/06/2020
    Part 3 of 5
    AVEENO BABY DAILY MOISTURE 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 MONOOLEATE (UNII: C4YAD5F5G6)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRGUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    INGROAT (UNII: Z6J799EAJK)  
    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
    Cosmetic07/06/2020
    Part 4 of 5
    AVEENO BABY CALMING COMFORT BATH 
    baby shampoos solution
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRSODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    INGRPOLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRCOCO GLUCOSIDE (UNII: ICS790225B)  
    INGRCARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGROAT (UNII: Z6J799EAJK)  
    INGRGLYCERYL OLEATE (UNII: 4PC054V79P)  
    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 5 of 5
    AVEENO BABY SENSITIVE ALL OVER WIPES 
    other personal cleanliness products cloth
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRGLYCERYL OLEATE (UNII: 4PC054V79P)  
    INGRCARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    INGRPOLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    INGRLAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGROAT (UNII: Z6J799EAJK)  
    INGRCOCO GLUCOSIDE (UNII: ICS790225B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    164 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic06/14/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2022
    Labeler - Johnson & Johnson Consumer Inc. (118772437)