NDC 69422-1003 Carecella Velvet Cover Bb Cream

Octinoxate, Titanium Dioxide, Zinc Oxide

NDC Product Code 69422-1003

NDC Code: 69422-1003

Proprietary Name: Carecella Velvet Cover Bb Cream What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Octinoxate, Titanium Dioxide, Zinc Oxide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 69422 - General Bio Co., Ltd.

NDC 69422-1003-2

Package Description: 1 TUBE in 1 BOX > 50 g in 1 TUBE (69422-1003-1)

NDC Product Information

Carecella Velvet Cover Bb Cream with NDC 69422-1003 is a a human over the counter drug product labeled by General Bio Co., Ltd.. The generic name of Carecella Velvet Cover Bb Cream is octinoxate, titanium dioxide, zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: General Bio 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.

Carecella Velvet Cover Bb Cream 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 2.1 g/50g
  • ZINC OXIDE 3.5 g/50g
  • OCTINOXATE 3.75 g/50g

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: General Bio Co., Ltd.
Labeler Code: 69422
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: 05-10-2019 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.

Carecella Velvet Cover Bb Cream 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

Directions

Apply the adequate amount onto the entire face at the last stage of your skin care routine.Apply liberally 15 minutes before sun exposure.Use a water-resistant sunscreen if swimming or sweating.Children under 6 months of age: ask a doctor

Warnings

For external use onlySkin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.Do not use when skin is red, inflamed, irritated, or painfulWhen using this productdo not apply on other parts of the bodydo not use on damaged or broken skinavoid contact with eyes. If contact occurs, rinse eyes thoroughly with waterdo not apply directly to wound or open cutStop use and ask a doctor ifRash or irritation on skin develops and lasts

Inactive Ingredients

Water, Cyclopentasiloxane, Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Ethylhexyl Palmitate, Sorbitan Sesquioleate, Caprylic/Capric Triglyceride, Arbutin, Dimethicone, Dipropylene Glycol, CI 77492, Sodium Chloride, 1,2-Hexanediol, Beeswax,Disteardimonium Hectorite, Magnesium Aluminum Silicate,CI 77491, Hydroxyacetophenone,Dimethicone/Vinyl Dimethicone Crosspolymer, CI 77499,PEG-10 Dimethicone Crosspolymer, Ozokerite,Aluminum Hydroxide, Triethoxycaprylylsilane, Lavandula Angustifolia (Lavender) Oil, Adenosine, Allantoin, Panthenol,Chamomilla Recutita (Matricaria) Flower Extract,Gentiana Lutea Root Extract, Artemisia Absinthium Extract, Portulaca Oleracea Extract, Acer Saccharum (Sugar Maple) Extract, Caprylyl Glycol.

Uses

Helps prevent sunburn

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Purpose

Sunscreen

Active Ingredient

Octinoxate (7.5%) ----- SunscreenTitanium Dioxide (4.2%) ------------------------- SunscreenZinc Oxide (7%) --------------------------------- Sunscreen

* Please review the disclaimer below.