NDC 73391-0001 Whamisa Organic Carrot Baby Kids Suncream Spf 50 Pa

Zinc Oxide

NDC Product Code 73391-0001

NDC 73391-0001-1

Package Description: 60 g in 1 TUBE

NDC Product Information

Whamisa Organic Carrot Baby Kids Suncream Spf 50 Pa with NDC 73391-0001 is a a human over the counter drug product labeled by Ens Korea Co., Ltd.. The generic name of Whamisa Organic Carrot Baby Kids Suncream Spf 50 Pa is zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Ens Korea Co., Ltd.

Dosage Form: Cream - 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.

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.

Whamisa Organic Carrot Baby Kids Suncream Spf 50 Pa 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 24 g/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.

  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • ISOSTEARIC ACID (UNII: X33R8U0062)

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.
  • 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: Ens Korea Co., Ltd.
Labeler Code: 73391
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 11-01-2019 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.

Whamisa Organic Carrot Baby Kids Suncream Spf 50 Pa Product Label Images

Whamisa Organic Carrot Baby Kids Suncream Spf 50 Pa 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

Otc - Active Ingredient

Zinc oxide

Otc - Purpose

UV protection

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

Apply an appropriate amount to areas exposed to ultraviolet rays

Warnings

For external use only.

UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.

When using the product Keep out of eyes. Rinse with water to remove.

Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center

Inactive Ingredient

*Daucus Carota Sativa (Carrot) Root Extract

*Avena Sativa (Oat) Kernel Extract

Zinc Oxide

Coco-Caprylate/Caprate

*Daucus Carota Sativa (Carrot) Seed Oil

*Olea Europaea (Olive) Fruit Oil

*Astrocaryum Murumuru Seed Butter

Sorbitan Olivate

*Calendula Officinalis Flower Oil

*Camellia Japonica Seed Oil

*Lactobacillus/Daucus Carota Sativa (Carrot) Root Ferment Filtrate

*Lactobacillus/Aloe Barbadensis Ferment Filtrate

Lactobacillus Ferment

Beta-Glucan

Polyglyceryl-2 Dipolyhydroxystearate

Isostearic Acid

Euphorbia Cerifera (Candelilla) Wax

Copernicia Cerifera (Carnauba) Wax

Polyhydroxystearic Acid

***Scutellaria Baicalensis Root Extract

***Paeonia Suffruticosa Root Extract

***Glycyrrhiza Glabra (Licorice) Root Extract

Jasminum Officinale (Jasmine) Oil

Salvia Officinalis (Sage) Oil

Citrus Aurantium Bergamia (Bergamot) Fruit Oil

Aniba Rosodora (Rosewood) Wood Oil

**Fragrance

"*Certified Organically Grown **Natural Origin ***Naturally derived extract in

Preservative function / Bergamot Oil Bergaptene Free"

Dosage & Administration

For external use only

* Please review the disclaimer below.