NDC 80785-0001 Ex Cuseme Brightening Suncream

Titanium Dioxide

NDC Product Code 80785-0001

NDC 80785-0001-1

Package Description: 75 g in 1 TUBE

NDC Product Information

Ex Cuseme Brightening Suncream with NDC 80785-0001 is a a human over the counter drug product labeled by Bbc Inc. The generic name of Ex Cuseme Brightening Suncream is titanium dioxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Bbc Inc

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.

Ex Cuseme Brightening 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 2.075 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.

  • 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: Bbc Inc
Labeler Code: 80785
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: 10-18-2020 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.

Ex Cuseme Brightening Suncream Product Label Images

Ex Cuseme Brightening 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

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

Sambucus Nigra Flower Extract

Glycerin

1,2-Hexanediol

Ethylhexylglycerin

Glycerin

Ethylhexyl Methoxycinnamate

Ethylhexyl Salicylate

Cyclopentasiloxane

Cyclohexasiloxane

Centella Asiatica Extract

1,2-Hexanediol

Dicaprylyl Carbonate

Aluminum Hydroxide

Stearic Acid

Niacinamide

Butylene Glycol

Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine

Diethylamino Hydroxybenzoyl Hexyl Benzoate

Cetearyl Alcohol

1,2-Hexanediol

Arachidyl Alcohol

Behenyl Alcohol

Arachidyl Glucoside

Phenyl Trimethicone

Caulerpa Lentillifera Extract

Sea Cucumber Extract

1,2-Hexanediol

Paeonia Suffruticosa Root Extract

Schisandra Chinensis Fruit Extract

Lycium Chinense Fruit Extract

1,2-Hexanediol

Sambucus Nigra Flower Extract

Chamomilla Recutita (Matricaria) Flower Extract

Calendula Officinalis Flower Extract

1,2-Hexanediol

Glyceryl Stearate

Stearic Acid

Potassium Cetyl Phosphate

Polymethyl Methacrylate

Ammonium Acryloyldimethyltaurate/VP Copolymer

Xanthan Gum

Dipropylene glycol

Lavandula hybrida oil

Pelargonium graveolens flower oil

Rosmarinus officinalis (rosemary) leaf oil

Eucalyptus globulus leaf oil

Tromethamine

Carbomer

Adenosine

Dipotassium Glycyrrhizate

Disodium EDTA

Panthenol

rh-Oligopeptide-1

Ceramide NP

(-)-Alpha-Bisabolol

Indications & Usage

Apply proper amount to the skin

* Please review the disclaimer below.