AVEENO BABY DAILY CARE SET- dimethicone 
Johnson & Johnson Consumer Inc.

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.

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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

  • 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

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - Kit Package Label

RECOMMENDED BY
PEDIATRICIANS
& DERMATOLOGISTS
Aveeno ®
baby
daily care set
daily nourishment for
baby's sensitive skin
cleanse gently                     protect and moisturize
12 FL OZ (354mL)              12 FL OZ (354mL)

PRINCIPAL DISPLAY PANEL - Kit Package Label
AVEENO BABY DAILY CARE SET 
dimethicone kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0632
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0632-91 in 1 PACKAGE11/30/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PUMP 354 mL
Part 21 BOTTLE, PUMP 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
GLYCERIN (UNII: PDC6A3C0OX)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
PETROLATUM (UNII: 4T6H12BN9U)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
WATER (UNII: 059QF0KO0R)  
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 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 OLEATE (UNII: 4PC054V79P)  
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
1354 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic07/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/30/2020
Labeler - Johnson & Johnson Consumer Inc. (118772437)

Revised: 1/2023
Document Id: eeaa1977-2ba8-e11e-e053-2995a90ab0ff
Set id: 3d3da49e-dba6-4c6b-9278-5c8692e29f14
Version: 4
Effective Time: 20230106
 
Johnson & Johnson Consumer Inc.