NDC 73391-0007 Whamisa Organic Flowers Natural Tone Up Sun Pact Spf 50 Pa

Zinc Oxide

NDC Product Code 73391-0007

NDC 73391-0007-1

Package Description: 16 g in 1 CONTAINER

NDC Product Information

Whamisa Organic Flowers Natural Tone Up Sun Pact Spf 50 Pa with NDC 73391-0007 is a a human over the counter drug product labeled by Ens Korea Co., Ltd.. The generic name of Whamisa Organic Flowers Natural Tone Up Sun Pact Spf 50 Pa is zinc oxide. The product's dosage form is powder and is administered via topical form.

Labeler Name: Ens Korea Co., Ltd.

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

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 Flowers Natural Tone Up Sun Pact 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 Flowers Natural Tone Up Sun Pact Spf 50 Pa Product Label Images

Whamisa Organic Flowers Natural Tone Up Sun Pact 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

*Aloe Barbadensis Leaf Extract

*Oryza Sativa (Rice) Extract

Coco-Caprylate/Caprate

*Vitis Vinifera (Grape) Seed Oil

*Olea Europaea (Olive) Fruit Oil

*Persea Gratissima (Avocado) Oil

Sorbitan Olivate

Polyglyceryl-2 Dipolyhydroxystearate

*Brassica Oleracea Acephala Leaf Extract

*Spinacia Oleracea (Spinach) Leaf Extract

*Persea Gratissima (Avocado) Butter

*Mangifera Indica (Mango) Seed Butter

*Lactobacillus/Chrysanthemum Sinense Flower Ferment Filtrate

*Lactobacillus/Nelumbo Nucifera Flower Ferment Filtrate

*Lactobacillus/Taraxacum Officinale (Dandelion) Rhizome/Root Ferment Filtrate

Isostearic Acid

Copernicia Cerifera (Carnauba) Wax

Euphorbia Cerifera (Candelilla) Wax

Polyhydroxystearic Acid

Cetearyl Alcohol

Cetyl Alcohol

Aniba Rosodora (Rosewood) Wood Oil

Mentha Piperita (Peppermint) Oil

***Scutellaria Baicalensis Root Extract

***Paeonia Suffruticosa Root Extract

***Glycyrrhiza Glabra (Licorice) Root Extract

**Fragrance

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

Preservative function / Allergen: d-Limonene

Dosage & Administration

For external use only

* Please review the disclaimer below.