NDC 69968-0583 Aveeno Baby Continuous Protection Sensitive Skin Sunscreen Broad Spectrum Spf 50

Zinc Oxide

NDC Product Code 69968-0583

NDC Code: 69968-0583

Proprietary Name: Aveeno Baby Continuous Protection Sensitive Skin Sunscreen Broad Spectrum Spf 50 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.

Non-Proprietary Name: Zinc Oxide 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.

NDC Code Structure

  • 69968 - Johnson & Johnson Consumer Inc.
    • 69968-0583 - Aveeno Baby Continuous Protection Sensitive Skin Sunscreen Broad Spectrum Spf 50

NDC 69968-0583-1

Package Description: 1 CANISTER in 1 BLISTER PACK > 13 g in 1 CANISTER

NDC Product Information

Aveeno Baby Continuous Protection Sensitive Skin Sunscreen Broad Spectrum Spf 50 with NDC 69968-0583 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Aveeno Baby Continuous Protection Sensitive Skin Sunscreen Broad Spectrum Spf 50 is zinc oxide. The product's dosage form is stick and is administered via topical form.

Labeler Name: Johnson & Johnson Consumer Inc.

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

Product Type: Human Otc Drug 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.

Aveeno Baby Continuous Protection Sensitive Skin Sunscreen Broad Spectrum Spf 50 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ZINC OXIDE 216 g/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
  • CERESIN (UNII: Q1LS2UJO3A)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • OAT KERNEL OIL (UNII: 3UVP41R77R)

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.

Labeler Name: Johnson & Johnson Consumer Inc.
Labeler Code: 69968
FDA Application Number: part352 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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.

Start Marketing Date: 10-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Aveeno Baby Continuous Protection Sensitive Skin Sunscreen Broad Spectrum Spf 50 Product Label Images

Aveeno Baby Continuous Protection Sensitive Skin Sunscreen Broad Spectrum Spf 50 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

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

Active Ingredients

Zinc Oxide (21.6%)

Purpose

Sunscreen

Uses

  • Helps prevent sunburnif used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Otc - Do Not Use

Do not use on damaged or broken skin

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

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.

Directions

  • Apply generously and evenly 15 minutes before sun exposureensure complete coverage to the area above the lip, nose, and tops of earsreapply:after 80 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hoursSun 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 sunglasseschildren under 6 months of age: Ask a doctor

Other Information

  • Protect this product from excessive heat and direct sunmay stain some fabricspackage contains small parts, which could cause a choking hazard

Inactive Ingredients

Octyldodecyl Neopentanoate, C12-15 Alkyl Benzoate, Polyethylene, Paraffin, Silica, Neopentyl Glycol Diethylhexanoate, Ozokerite, Isopropyl Myristate, Adipic Acid/Diglycol Crosspolymer, Triethoxycaprylylsilane, Neopentyl Glycol Diisostearate, Caprylyl Glycol, Avena Sativa (Oat) Kernel Oil

Questions?

Call toll-free 866-428-3366 or 215-273-8755 (collect).www.aveeno.com

* Please review the disclaimer below.