NDC 69422-1005 Carecella Velvet Cover Bb Cream No 25

Octyl Methoxycinnamate, Titanium Dioxide, Zinc Oxide

NDC Product Code 69422-1005

NDC 69422-1005-2

Package Description: 1 TUBE in 1 BOX > 50 mL in 1 TUBE (69422-1005-1)

NDC Product Information

Carecella Velvet Cover Bb Cream No 25 with NDC 69422-1005 is a a human over the counter drug product labeled by General Bio Co., Ltd.. The generic name of Carecella Velvet Cover Bb Cream No 25 is octyl methoxycinnamate, 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 No 25 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.

  • ZINC OXIDE 7 g/100mL
  • OCTINOXATE 7.5 g/100mL
  • TITANIUM DIOXIDE 4.2 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.

  • 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.
  • 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: 10-26-2020 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.

Carecella Velvet Cover Bb Cream No 25 Product Label Images

Carecella Velvet Cover Bb Cream No 25 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

Octyl Methoxycinnamate (7.5%)Titanium Dioxide (4.2%)

Zinc Oxide (7%)

Otc - Purpose

Sunscreen

Indications & Usage

Helps to prevent sunburn

Warnings

For external use only.

Otc - Do Not Use

  • If you are allergic to any of the ingredientson damaged or broken skin

Otc - When Using

  • Keep out of eyes. Rinse with water to remove.

Otc - Stop Use

  • Rash or irritation develops and lasts.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

  • Apply liberally on cleansed skin 15 minutes prior to sun exposure.Reapply as needed or after towel drying, swimming or sweating.At least every 2 hoursChildren under 6 months: Ask a doctor.

Other Safety Information

  • Store in a cool dry place away from direct sunlight.(You may add “high sun protection product” for SPF protection 30 or above)“Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.”

Inactive Ingredient

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

* Please review the disclaimer below.