NDC 81345-020 Br Waterfull Bb Blemish Balm Natural

Titanium Dioxide, Octinoxate

NDC Product Code 81345-020

NDC 81345-020-01

Package Description: 40 g in 1 CARTON

NDC Product Information

Br Waterfull Bb Blemish Balm Natural with NDC 81345-020 is a a human over the counter drug product labeled by Brcosmetic. The generic name of Br Waterfull Bb Blemish Balm Natural is titanium dioxide, octinoxate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Brcosmetic

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.

Br Waterfull Bb Blemish Balm Natural 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 2.8 g/40g
  • OCTINOXATE .6 g/40g

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)
  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Brcosmetic
Labeler Code: 81345
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: 12-01-2020 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.

Br Waterfull Bb Blemish Balm Natural Product Label Images

Br Waterfull Bb Blemish Balm Natural 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

Active Ingredients

Titanium Dioxide 7.0%, Ethylhexyl Methoxycinnamate 1.5%

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Glycerin, Propylene Glycol, Petrolatum, Cetyl Ethylhexanoate, Cyclopentasiloxane, Cyclohexasiloxane, Cetyl PEG/PPG-10/1Dimethicone, Dimethicone, Beeswax, Centella Asiatica Extract, Aloe Barbadensis Leaf Juice, Biosaccharide Gum-1, Trehalose, Panthenol, Sodium hyaluronate, Sodium Chloride, Sorbitan Sesquioleate, Lavandula Angustifolia (Lavender) Flower Extract, Monarda Didyma Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Freesia Refracta Extract, Chamomilla Recutita(Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Paeonia Suffruticosa Root Extract, Scutellaria Baicalensis Root Extract, Butylene Glycol, Caprylhydroxamic Acid, Caprylyl Glycol, Allantoin, Tocopheryl Acetate, Iron Oxide (CI 77492), Iron Oxide (CI 77491), Iron Oxide (CI 77499), Triethoxycaprylylsilane, Talc, BHT, Disodium EDTA, Fragrance

Purpose

Sunscreen

Warnings

1. If the following side effects occur, immediately discontinue use. Before resuming use, consult a dermatologist as continual use may worsen symptoms. A) If red spots, swelling, itching, irritation, or other discomforts occur after using the product. B) If the above symptoms occur on the applied area after exposure to direct sunlight. 2. Do not use on open wounds or on areas of skin exhibiting signs of eczema or dermatitis. 3. Storage and handling precautions A) Keep product out of reach of infants and children. B) Ensure that lid is closed after use. C) Do not store in places subject to high or cold temperatures or under exposure to direct sunlight. D) Use care to avoid eye contact when using this product.

Description

Indications & Usage: 1. Shake before using, apply evenly to clean face after skin care and treatment serum. 2. Tap applied face softly for better absorption. 3. Always replace cap after useDosage & Administration: Apply appropriate amount onto face after applying activator or cleansing.

* Please review the disclaimer below.