AVEENO BABY SOOTHING HYDRATION CREAMY OIL- 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.

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Aveeno ® baby soothing hydration creamy oil

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

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 - 227 g Tube Label

RECOMMENDED BY
PEDIATRICIANS
& DERMATOLOGISTS
Aveeno ®
baby
soothing hydration
New Look
Now with
Vitamin E
creamy
oil
dimethicone skin protectant
with 100% pure oat oil
+ vitamin E
helps heal dry skin
restores essential
moisture to baby's
sensitive skin
fragrance-free
hypoallergenic
NET WT. 8 OZ (227 g)

Principal Display Panel - 227 g Tube Label
AVEENO BABY SOOTHING HYDRATION CREAMY OIL 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0630
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)  
OAT (UNII: Z6J799EAJK)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
OAT KERNEL OIL (UNII: 3UVP41R77R)  
STEARETH-20 (UNII: L0Q8IK9E08)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SHEA BUTTER (UNII: K49155WL9Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0630-5141 g in 1 TUBE; Type 0: Not a Combination Product06/01/202005/23/2023
2NDC:69968-0630-8227 g in 1 TUBE; Type 0: Not a Combination Product06/01/202002/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/01/202005/23/2023
Labeler - Johnson & Johnson Consumer Inc. (118772437)

Revised: 3/2023
Document Id: f5d0c5bf-f214-7932-e053-2995a90a02c6
Set id: 003fb7de-3c39-4840-ad3c-b2e83e1e2278
Version: 3
Effective Time: 20230301
 
Johnson & Johnson Consumer Inc.