NDC 71014-010 Foundation Broad Spectrum Spf 35 Cooly Beige Vertra

Titanium Dioxide

NDC Product Code 71014-010

NDC CODE: 71014-010

Proprietary Name: Foundation Broad Spectrum Spf 35 Cooly Beige Vertra 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

  • 71014 - Eai-jr286, Inc.
    • 71014-010 - Foundation Broad Spectrum Spf 35 Cooly Beige

NDC 71014-010-02

Package Description: 1 CYLINDER in 1 BOX > 11 g in 1 CYLINDER (71014-010-01)

NDC Product Information

Foundation Broad Spectrum Spf 35 Cooly Beige Vertra with NDC 71014-010 is a a human over the counter drug product labeled by Eai-jr286, Inc.. The generic name of Foundation Broad Spectrum Spf 35 Cooly Beige Vertra is titanium dioxide. The product's dosage form is stick and is administered via topical form.

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.

Foundation Broad Spectrum Spf 35 Cooly Beige Vertra 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.


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)
  • HEXYLDECYL ISOSTEARATE (UNII: 3V20TC06U5)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • MICA (UNII: V8A1AW0880)
  • CERESIN (UNII: Q1LS2UJO3A)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
  • 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: Eai-jr286, Inc.
Labeler Code: 71014
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: 10-07-2016 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Foundation Broad Spectrum Spf 35 Cooly Beige Vertra 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

Active Ingredients                     PurposeTitanium Dioxide 23%           Sunscreen

Otc - Purpose

  • Useshelps prevent sunburnif used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sunHigher SPF gives more sunburn protectionRetains 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 chilcren. 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

  • Warnings For external use onlyDo not use on damaged or broken skinWhen using this product  keep out of eyesRinse with water to remove

Dosage & Administration

  • Directionsapply liberally and evenly 15 minutes before sun exposureapply to all skin exposed to sun use a water resistant sunscreen if swimming or sweating reapply: after 80 minutes of swimming or sweating immediately after towel dryingat leasty every 2 hoursSun 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 15 or higher and other sun protection measures including:limit time in the sun, especially from 10 a.m. - 2 p.m.wear long-sleeve shirts, pants, hats, and sunglasseschildren under 6 months of age: ask a doctor

Inactive Ingredient

Hexyldecyl Isostearate, Mica, Synthetic Wax, Paraffin, Ozokerite, Polyglyceryl-2 Oleate, Aluminum Hydroxide, Stearic Acid, Ethylene/Propylene Copolymer, Tocopheryl, Fragrance, Iron oxides

* Please review the disclaimer below.