NDC 69968-0630 Aveeno Baby Soothing Hydration Creamy Oil
Dimethicone Cream Topical

Product Information

What is NDC 69968-0630?

The NDC code 69968-0630 is assigned by the FDA to the product Aveeno Baby Soothing Hydration Creamy Oil which is a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Aveeno Baby Soothing Hydration Creamy Oil is dimethicone. The product's dosage form is cream and is administered via topical form. The product is distributed in 2 packages with assigned NDC codes 69968-0630-5 141 g in 1 tube , 69968-0630-8 227 g in 1 tube . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code69968-0630
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Aveeno Baby Soothing Hydration Creamy Oil
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Dimethicone
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormCream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Johnson & Johnson Consumer Inc.
Labeler Code69968
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
part347
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
06-01-2020
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2024
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Aveeno Baby Soothing Hydration Creamy Oil?


Product Packages

NDC Code 69968-0630-5

Package Description: 141 g in 1 TUBE

NDC Code 69968-0630-8

Package Description: 227 g in 1 TUBE

Product Details

What are Aveeno Baby Soothing Hydration Creamy Oil Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Aveeno Baby Soothing Hydration Creamy Oil Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Other



Aveeno® baby soothing hydration creamy oil

Drug Facts

Aveeno® baby daily moisture lotion

Drug Facts

Aveeno DAILY MOISTURIZING lotion

Drug Facts

For external use only.

Aveeno® POSITIVELY RADIANT® daily moisturizer sunscreen BROAD SPECTRUM SPF 15

Drug Facts

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


Active Ingredient



Dimethicone 1.2%

Dimethicone 1.2%

Dimethicone (1.2%)


Purpose



Skin Protectant

Skin Protectant

Skin Protectant


Uses



  • Helps prevent and temporarily protects chafed, chapped or cracked skin
    • Helps prevent and temporarily protects chafed, chapped or cracked skin
      • Helps prevent and temporarily protects chafed, chapped or cracked skin
      • Helps prevent and protect from the drying effects of wind and cold weather

Warnings



For external use only

For external use only

  • For external use only

When Using This Product



  • do not get into eyes
    • Do not get into eyes
      • 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
    • Condition worsens
    • Symptoms last more than 7 days or clear up and occur again within a few days
      • 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
    • Deep or puncture wounds
    • Animal bites
    • Serious burns
      • Deep or puncture wounds
      • Animal bites
      • Serious burns.

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions



  • Apply as needed.
    • Apply as needed.
    • Apply as needed.

      For sunscreen use:

      • apply generously and evenly 15 minutes before sun exposure
      • reapply at least every 2 hours
      • use a water resistant sunscreen if swimming or sweating
      • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
        • limit time in the sun, especially from 10 a.m. - 2 p.m.
        • wear long-sleeved shirts, pants, hats, and sunglasses
        • children under 6 months of age: Ask a doctor

Other Information



  • To open, twist off cap and remove quality seal. Do not use if quality seal is broken.
  • Store at room temperature.
    • To open, twist off cap and remove quality seal. Do not use if quality seal is broken.
    • Store at room temperature.
    • Store at Room Temperature

      • protect this product from excessive heat and direct sun
      • may stain some fabrics

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.

Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Sodium Chloride, Allantoin

Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Sodium Chloride

Water, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Dimethicone, Glycine Soja (Soyabean) Seed Extract, Phenyl Trimethicone, Glycerin, Arachidyl Alcohol, Cetearyl Glycoside, Phenoxyethanol, Benzyl Alcohol, Panthenol, Ethylene/Acrylic Acid Copolymer, Behenyl Alcohol, Steareth-2, Fragrance, Steareth-21, Polymethyl Methacrylate, Polyacrylamide, Arachidyl Glucoside, Disodium EDTA, C13-14 Isoparaffin, Laureth-7, Silica, Benzalkonium Chloride, Iodopropynyl Butylcarbamate, BHT, Sodium Hydroxide, Citric Acid, Titanium Dioxide, Mica


Questions?



866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com


Otc - Purpose



Active ingredientPurpose
Avobenzone 3%Sunscreen
Octinoxate 7.5%Sunscreen
Octisalate 2 %Sunscreen

Use



  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer an early skin aging caused by the sun

Otc - Do Not Use



  • Do not use on damaged or broken skin

Otc - When Using



  • When using this product keep out of eyes. Rinse with water to remove

Otc - Stop Use



  • Stop use and ask a doctor if rash occurs

Principal Display Panel - Kit Package



RECOMMENDED BY

PEDIATRICIANS
& DERMATOLOGISTS

Aveeno®

baby

essential

daily care

mommy & me

gift set

for BABY

Daily Moisture Wash & Shampoo 8 fl oz

(236 mL), Daily Moisture Lotion NET WT.

8 oz (227 g), Soothing Hydration Creamy

Wash 8 fl oz (236 mL), Soothing Hydration

Creamy Oil NET WT. 5 oz (141 g)

FOR MOM

Positively Radiant® Daily Moisturizer

Broad Spectrum SPF 15 4 fl oz

(120 mL), Daily Moisturizing Lotion

NET WT. 2.5 oz (71 g)


* Please review the disclaimer below.