NDC 57627-113 Flawless Effect Liquid Foundation Spf 15 Merle Norman

Octinoxate, Oxybenzone

NDC Product Code 57627-113

NDC CODE: 57627-113

Proprietary Name: Flawless Effect Liquid Foundation Spf 15 Merle Norman 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, Oxybenzone 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

  • 57627 - Merle Norman
    • 57627-113 - Flawless Effect Liquid Foundation Spf 15

NDC 57627-113-02

Package Description: 1 BOTTLE in 1 CARTON > 30 g in 1 BOTTLE (57627-113-01)

NDC Product Information

Flawless Effect Liquid Foundation Spf 15 Merle Norman with NDC 57627-113 is a a human over the counter drug product labeled by Merle Norman. The generic name of Flawless Effect Liquid Foundation Spf 15 Merle Norman is octinoxate, oxybenzone. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Merle Norman

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.

Flawless Effect Liquid Foundation Spf 15 Merle Norman 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.

  • OXYBENZONE .9 g/30g
  • OCTINOXATE 2.25 g/30g

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.

  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • MICA (UNII: V8A1AW0880)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
  • FERROUS OXIDE (UNII: G7036X8B5H)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • GLYCERYL 1-OLEATE (UNII: D3AEF6S35P)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
  • DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
  • GINKGO (UNII: 19FUJ2C58T)
  • CHAMOMILE (UNII: FGL3685T2X)
  • TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

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: Merle Norman
Labeler Code: 57627
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: 04-25-2011 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.

Flawless Effect Liquid Foundation Spf 15 Merle Norman Product Label Images

Flawless Effect Liquid Foundation Spf 15 Merle Norman 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 IngredientsOctinoxate 7.50%Oxybenzone 3.00%

Otc - Purpose

Uses · 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

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

Stop use and ask a doctor if rash occurs

Warnings

Warnings· For external use only· Do not use on damaged or broken skin· When using this product keep out of eyes. Rinse with water to remove.

Dosage & Administration

DirectionsFor Sunscreen Use:· Apply liberally 15 minutes before sun exposure· Use a water resistant sunscreen if swimming or sweating· Reapply at least every 2 hours· Sun Protection Measures. Spending time in the sun increases your risk of skincancer and early skin aging. To decrease this risk, regularly use a sunscreenwith broad spectrum SPF of 15 or higher and other sun protection measuresincluding:· limit time in the sun, especially from 10 a.m. - 2 p.m.· wear long-sleeve shirts, pants, hats, and sunglasses· Children under 6 months: Ask a doctor

Inactive Ingredient

Water(aqua), cyclopentasiloxane , mica, titanium dioxide, diisostearyl malate, ethylhexyl palmitate, glycerin, pentylene glycol, peg-30 dipolyhydroxystearate, iron oxides, propylene glycol, cyclohexasiloxane, aluminum starch octenylsuccinate, disteardimonium hectorite, hdi/ppg/polycaprolactone crosspolymer, glyceryl oleate, glyceryl stearate, myristyl myristate, polyglyceryl-3 beeswax, lecithin, disodium stearoyl glutamate, Butylene Glycol,  sodium hyaluronate, camellia oleifera leaf extract, ginkgo biloba leaf extract, chamomilla recutita (matricaria) flower extract, tetrahexyldecyl ascorbate, tocopheryl acetate, aluminum hydroxide (Cl 77002), silica, alcohol denat., BHT, phenoxyethanol, methylparaben, propylparaben

* Please review the disclaimer below.