NDC 73793-0013 Coverqueen All In One Sun Roll

Zinc Oxide, Titanium Dioxide, Niacinamide, Adenosine

NDC Product Code 73793-0013

NDC 73793-0013-1

Package Description: 40 g in 1 BOTTLE

NDC Product Information

Coverqueen All In One Sun Roll with NDC 73793-0013 is a a human over the counter drug product labeled by Skinfarm. The generic name of Coverqueen All In One Sun Roll is zinc oxide, titanium dioxide, niacinamide, adenosine. The product's dosage form is cream and is administered via topical form.

Labeler Name: Skinfarm

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.

Coverqueen All In One Sun Roll 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.

  • ADENOSINE .04 g/100g
  • NIACINAMIDE 2 g/100g
  • ZINC OXIDE 13 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.

  • WATER (UNII: 059QF0KO0R)

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: Skinfarm
Labeler Code: 73793
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: 03-01-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Coverqueen All In One Sun Roll Product Label Images

Coverqueen All In One Sun Roll 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, Titanium Dioxide, Niacinamide, Adenosine

Inactive Ingredient

Water, Propylheptyl Caprylate, Acrylates Copolymer, Butyloctyl Salicylate, Dicaprylyl Ether, Butylene Glycol, Dicaprylate/Dicaprate, Disiloxane, Propanediol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Silica, Dimethicone, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Cetyl PEG/PPG-10/1 Dimethicone, Ethylhexylglycerin, Disteardimonium Hectorite, Magnesium Sulfate, 1,2-Hexanediol, Disodium EDTA, Fragrance, Citral, Citronellol, Limonene, Hexyl Cinnamal, Hydroxycitronellal, Linalool, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde,

Otc - Purpose

Helps prevent sunburn*if used as directed with other sun protection measures (see under Directions), decreases the risk of skin cancer and early skin aging by the sun

Otc - Keep Out Of Reach Of Children


Indications & Usage

Directions*Apply liberally 15 minutes before sun exposure*Apply all skin will be exposed to the sun*Reapply *after 80 minutes of swimming or sweating *immediately after towel drying*at least every 2 hours*children under the age of 6 months of age: ask a Doctor*Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: *limit time in the sun, especially from 10 AM to 2 PM *wear long-sleeve shirts, pants, hats, and sunglasses


WarningsFor external use onlyDo not use on damaged or broken skinWhen using this product keep out of eyes. Rinse with water to remove.Stop use and ask a Doctor if rash or redness occursKeep out of reach of children if swallowed, get medical help or contact Poison Control Center right awayOther information*do not store this product under the direct sun light or the excessive heat*may stain some fabrics or surfaces

Dosage & Administration

External use only

* Please review the disclaimer below.