NDC 80564-0001 Onalt Pure Mild Suncream

Titanium Dioxide, Zinc Oxide

NDC Product Code 80564-0001

NDC Product Information

Onalt Pure Mild Suncream with NDC 80564-0001 is a a human over the counter drug product labeled by Hnb9 Co., Ltd.. The generic name of Onalt Pure Mild Suncream is titanium dioxide, zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Hnb9 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.

Onalt Pure Mild Suncream 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.

  • TITANIUM DIOXIDE 10 g/100mL
  • ZINC OXIDE 12 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.

  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Hnb9 Co., Ltd.
Labeler Code: 80564
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: 09-22-2020 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: 12-31-2021 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.

Onalt Pure Mild Suncream Product Label Images

Onalt Pure Mild Suncream 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

Titanium dioxide, zinc oxide

Otc - Purpose

UV protectionskin whiteningwrinkle care

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF THE CHILDREN

Warnings

■ For external use only.■ Do not use in eyes.■ lf swallowed, get medical help promptly.■ Stop use, ask doctor lf irritation occurs.■ Keep out of reach of children.

Dosage & Administration

For external use only

Inactive Ingredient

Water

C12-15 Alkyl Benzoate

Cyclopentasiloxane

Glycerin

Methylpropanediol

Cetyl PEG/PPG-10/1 Dimethicone

Aluminum Hydroxide

Polyhydroxystearic Acid

Niacinamide

Cetyl Dimethicone

Sea Water

Cetyl Ethylhexanoate

Sorbitan Trioleate

Stearic Acid

Isostearic Acid

Sorbitan Sesquioleate

Trifluoropropyl Dimethicone

Benzyl Glycol

Disteardimonium Hectorite

Ozokerite

Sodium Chloride

Butylene Glycol

Silica Dimethyl Silylate

Polymethylsilsesquioxane

Fragrance

Silica

Tocopheryl Acetate

Sargassum Fulvellum Extract

Ethylhexylglycerin

Hizikia Fusiforme Extract

1,2-Hexanediol

Adenosine

Disodium EDTA

Ethylhexylglycerin

Indications & Usage

Apply proper amount to the skin

* Please review the disclaimer below.