NDC 66990-1025 Vertra Mick Fanning Signature Foundation Sunscreen Face Stick Spf 35 Coolangatta Beige

Titanium Dioxide

NDC Product Code 66990-1025

NDC CODE: 66990-1025

Proprietary Name: Vertra Mick Fanning Signature Foundation Sunscreen Face Stick Spf 35 Coolangatta Beige 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: Titanium Dioxide 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

  • 66990 - Toshiki Pigment Co., Ltd.
    • 66990-1025 - Vertra Mick Fanning Signature Foundation Sunscreen Face Stick Spf 35 Coolangatta Beige

NDC 66990-1025-1

Package Description: 11 g in 1 CARTON

NDC Product Information

Vertra Mick Fanning Signature Foundation Sunscreen Face Stick Spf 35 Coolangatta Beige with NDC 66990-1025 is a a human over the counter drug product labeled by Toshiki Pigment Co., Ltd.. The generic name of Vertra Mick Fanning Signature Foundation Sunscreen Face Stick Spf 35 Coolangatta Beige is titanium dioxide. The product's dosage form is stick and is administered via topical form.

Labeler Name: Toshiki Pigment Co., Ltd.

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

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.

Vertra Mick Fanning Signature Foundation Sunscreen Face Stick Spf 35 Coolangatta Beige 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 23 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.

  • MICA (UNII: V8A1AW0880)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • HEXYLDECYL ISOSTEARATE (UNII: 3V20TC06U5)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • CERESIN (UNII: Q1LS2UJO3A)
  • STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
  • POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM)
  • TOCOPHEROL (UNII: R0ZB2556P8)

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: Toshiki Pigment Co., Ltd.
Labeler Code: 66990
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 01-27-2021 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 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.

Vertra Mick Fanning Signature Foundation Sunscreen Face Stick Spf 35 Coolangatta Beige Product Label Images

Vertra Mick Fanning Signature Foundation Sunscreen Face Stick Spf 35 Coolangatta Beige 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

Ttianium Dioxide 23% ..............Sunscreen

Otc - Purpose

  • Helps prevent sunburn.If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.Higher SPF gives more sunburn protection.Retains SPF after 80 minutes activity in the water, sweating or perspiring.Provides high protection against sunburn.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children: If product is swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

  • Stop use and ask a doctor if:Rash or irritation develops and lasts.

Warnings

  • Do not use:On damaged or broken skinWhen using this product:Keep out of eyes. Rinse with water to remove.For external use only.

Dosage & Administration

  • Apply liberally and generously 15 minutes before sun exposure and at least every 2 hours.Children under 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 a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:Limit your time in the sun, especially from 10 a.m. - 2 p.m.Wear long-sleeved shirts, pants, hats, and sunglassesReapply:After 80 minutes of swimming or sweatingImmediately after towel dryingAt least every 2 hours

Inactive Ingredient

Hexyldecyl Isostearate, Aluminum Hydroxide, Mica, Iron Oxides, Stearic Acid, Paraffin, Ozokerite, Synthetic Wax, Ethylene/Propylene Copolymer, Polyglyceryl-2 Oleate, Tocopherol, Stearyl Glycyrrhetinate, Fragrance

Storage And Handling

  • Protect this product in this contianer from excessive heat and direct sun.

* Please review the disclaimer below.