NDC 47124-116 Kids Sunscreen Spf 50

Avobenzone 3.0% Homosalate 15.0% Octisalate 5.0% Octocrylene 10.0%

NDC Product Code 47124-116

NDC Code: 47124-116

Proprietary Name: Kids Sunscreen 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: Avobenzone 3.0% Homosalate 15.0% Octisalate 5.0% Octocrylene 10.0% 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

  • 47124 - Wegman
    • 47124-116 - Kids Sunscreen Spf 50

NDC 47124-116-05

Package Description: 170 g in 1 CAN

NDC 47124-116-10

Package Description: 340 g in 1 CAN

NDC Product Information

Kids Sunscreen Spf 50 with NDC 47124-116 is a a human over the counter drug product labeled by Wegman. The generic name of Kids Sunscreen Spf 50 is avobenzone 3.0% homosalate 15.0% octisalate 5.0% octocrylene 10.0%. The product's dosage form is spray and is administered via topical form.

Labeler Name: Wegman

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Kids Sunscreen 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.

  • AVOBENZONE 3 1/100g
  • HOMOSALATE 15 1/100g
  • OCTISALATE 5 1/100g
  • OCTOCRYLENE 10 1/100g

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
  • TOCOPHEROL (UNII: R0ZB2556P8)

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: Wegman
Labeler Code: 47124
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: 05-18-2018 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: 12-31-2019 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.

Kids Sunscreen Spf 50 Product Label Images

Kids Sunscreen 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

Active Ingredients                                                                             Purpose

Avobenzone 3%..................................................................................SunscreenHomosalate 15%.................................................................................SunscreenOctisalate 5%......................................................................................SunscreenOctocrylene 10%.................................................................................Sunscreen

Warningsfor External Use Only

Flammable: Do not use near heat, flme, or while smoking.Do not use on damaged or broken skinWhen using this product • Keep out of eyes. Rinse eyes with water to remove.Stop use and ask a doctor if rash occursKeep out of reach of children. If product is swallowed, get medical help orcontact a Poison Control Center right away.

* Please review the disclaimer below.

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