NDC 22700-129 Covergirl Outlast Stay Fabulous 3in1 Foundation Broad Spectrum Spf 20 - 820 Creamy Natural

Ensulizole

NDC Product Code 22700-129

NDC CODE: 22700-129

Proprietary Name: Covergirl Outlast Stay Fabulous 3in1 Foundation Broad Spectrum Spf 20 - 820 Creamy Natural 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: Ensulizole 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

  • 22700 - Noxell
    • 22700-129 - Covergirl Outlast Stay Fabulous 3in1 Foundation

NDC 22700-129-30

Package Description: 30 mL in 1 BOTTLE, PUMP

NDC Product Information

Covergirl Outlast Stay Fabulous 3in1 Foundation Broad Spectrum Spf 20 - 820 Creamy Natural with NDC 22700-129 is a a human over the counter drug product labeled by Noxell. The generic name of Covergirl Outlast Stay Fabulous 3in1 Foundation Broad Spectrum Spf 20 - 820 Creamy Natural is ensulizole. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Noxell

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Covergirl Outlast Stay Fabulous 3in1 Foundation Broad Spectrum Spf 20 - 820 Creamy 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.

  • ENSULIZOLE .03 mg/mL

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)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TALC (UNII: 7SEV7J4R1U)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
  • ARACHIDYL BEHENATE (UNII: 9G00Q0O2NS)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
  • ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
  • BEHENIC ACID (UNII: H390488X0A)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TALC (UNII: 7SEV7J4R1U)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
  • ARACHIDYL BEHENATE (UNII: 9G00Q0O2NS)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
  • ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
  • BEHENIC ACID (UNII: H390488X0A)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TALC (UNII: 7SEV7J4R1U)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
  • ARACHIDYL BEHENATE (UNII: 9G00Q0O2NS)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
  • ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
  • BEHENIC ACID (UNII: H390488X0A)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: Noxell
Labeler Code: 22700
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: 06-25-2012 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 - 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.

Covergirl Outlast Stay Fabulous 3in1 Foundation Broad Spectrum Spf 20 - 820 Creamy 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

Other

Drug Facts

PROCTER & GAMBLE, DISTR., HUNT VALLEY, MD 21030 USA

Active Ingredient

Ensulizole 3%

Purpose

Sunscreen

Uses

  • Helps 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 sun

Warnings

  • For external use only

Otc - Do Not Use

  • Do not use on damaged or broken skin

Otc - When Using

  • When using this product keep out of eyes. Rinse with water to remove

Otc - Stop Use

  • Stop use and ask a doctor if rash occurs

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

Directions

  • Apply liberally 15 minutes before sun exposurereapply at least every 2 hoursuse water resistant sunscreen if swimming or sweatingSun 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 time in sun, especially from 10 a.m. – 2 p.m.wear long-sleeved shirts, pants, hats, and sunglasseschildren under 6 months: ask a doctor

Other Information

  • Protect this product from excessive heat and direct sun

Inactive Ingredients

Water, cyclopentasiloxane, propylene glycol, talc, dimethicone, aluminum starch octenylsuccinate, sodium chloride, peg/ppg-18/18 dimethicone, pvp, benzyl alcohol, phenoxyethanol, sodium hydroxide, ethylene/methacrylate copolymer, trihydroxystearin, arachidyl behenate, methicone, silica, synthetic wax, sodium benzoate, hexyl laurate, polyglyceryl-4 isostearate, cetyl peg/ppg-10/1 dimethicone, isopropyl titanium triisostearate, ethylene brassylate, behenic acid, polyethylene, iron oxides, titanium dioxide.

Questions?

Call 1-800-426-8374

* Please review the disclaimer below.