NDC 73430-0005 Dr.nuell Multi Sun Block

Zinc Oxide

NDC Product Information

Dr.nuell Multi Sun Block with NDC 73430-0005 is a a human over the counter drug product labeled by Apharm Co., Ltd.. The generic name of Dr.nuell Multi Sun Block is zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Apharm 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.

Dr.nuell Multi Sun Block 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 4.9004028 g/100mL

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.

  • WATER (UNII: 059QF0KO0R)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

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: Apharm Co., Ltd.
Labeler Code: 73430
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.

Dr.nuell Multi Sun Block Product Label Images

Dr.nuell Multi Sun Block 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 - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

Before foundation BB cream, apply it as a substitute for a primer.if the foundation you use is dark, mix it with a small amount of sun block to adjust the tone before use

Warnings

1) if there is any abnormal symptom or side effect, such as red spot, swelling and itching when using cosmetlcs or after using due to direct sunlight, consult dermatologists

2) Do not use for wounded areas

3) Precautions for storage and handling

keep out of reach of children, store away from direct sunlight

4) avoid the eye area

Inactive Ingredient

Water, butylene glycol, cyclopentasiloxane, etc.

Dosage & Administration

For external use only

Otc - Purpose

Dual functionality for brightening and wrinkle improvement certified

Mild UV protection without irritation SPF 42, PA+++

* Please review the disclaimer below.