AVEENO BABY SOOTHING RELIEF MOISTURIZING- dimethicone cream 
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.

----------

Aveeno Baby ® Soothing Relief Moisturizing Cream

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

  • Twist off cap, remove quality seal. Apply liberally or as needed. Do not use if quality seal is broken

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, Avena Sativa (Oat) Kernel Oil, Steareth-20, Sodium Chloride, Butyrospermum Parkii (Shea) Butter, Avena Sativa (Oat) Kernel Extract

Questions?

Call toll-free 866-4AVEENO or 215-273-8755 (collect).www.aveeno.com

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

PRINCIPAL DISPLAY PANEL - 226 g Tube Label

Aveeno
Baby ®

PEDIATRICIAN
Aveeno ®
RECOMMENDED ®

FRAGRANCE-FREE.PARABEN-FREE
PHTHALATE-FREE

Soothing Relief
Moisturizing Cream

Dimethicone Skin Protectant
Natural Triple Oat Complex

Clinically Shown to
Soothe & Relieve Dry Sensitive Skin

Moisturizes for 24 Hours

NET WT. 8 OZ. (226 g)

Principal Display Panel - 226 g Tube Label
AVEENO BABY SOOTHING RELIEF MOISTURIZING 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0198
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)  
OAT (UNII: Z6J799EAJK)  
OAT KERNEL OIL (UNII: 3UVP41R77R)  
SHEA BUTTER (UNII: K49155WL9Y)  
STEARETH-20 (UNII: L0Q8IK9E08)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0198-8226 g in 1 TUBE; Type 0: Not a Combination Product10/22/201512/15/2020
2NDC:69968-0198-5141 g in 1 TUBE; Type 0: Not a Combination Product10/22/201509/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/22/201512/15/2020
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 9/2021
Document Id: cb8fe0fa-79b3-7cac-e053-2a95a90a79ed
Set id: c2a7d5bb-a904-4cde-990d-b096574f6afc
Version: 4
Effective Time: 20210909
 
Johnson & Johnson Consumer Inc.