NDC 57627-126 Alabaster Perfecting Makeup Spf 25 Merle Norman

Octinoxate, Titanium Dioxide

NDC Product Code 57627-126

NDC CODE: 57627-126

Proprietary Name: Alabaster Perfecting Makeup Spf 25 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, 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

  • 57627 - Merle Norman Cosmetics, Inc
    • 57627-126 - Alabaster Perfecting Makeup Spf 25

NDC 57627-126-01

Package Description: 30 mL in 1 BOTTLE

NDC Product Information

Alabaster Perfecting Makeup Spf 25 Merle Norman with NDC 57627-126 is a a human over the counter drug product labeled by Merle Norman Cosmetics, Inc. The generic name of Alabaster Perfecting Makeup Spf 25 Merle Norman is octinoxate, titanium dioxide. The product's dosage form is emulsion and is administered via topical form.

Labeler Name: Merle Norman Cosmetics, Inc

Dosage Form: Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)

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.

Alabaster Perfecting Makeup Spf 25 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.

  • OCTINOXATE 2.25 g/30mL
  • TITANIUM DIOXIDE 2.13 g/30mL

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)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • ISODODECANE (UNII: A8289P68Y2)
  • CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

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 Cosmetics, Inc
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: 09-07-2012 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 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.

Alabaster Perfecting Makeup Spf 25 Merle Norman Product Label Images

Alabaster Perfecting Makeup Spf 25 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 Ingredients purposeOctinoxate 7.5% SunscreenTitanium Dioxide 7.1% Sunscreen

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 swallowed, get medical help orcontact a Poison Control Center right away.

Indications & Usage

· Stop use and ask a doctor if rash occurs and persists

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

Directions· Apply liberally 15 minutes before sun exposure· Reapply at least every 2 hours· Use a water resistant sunscreen if swimming or sweating· 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

Inactive IngredientsWater (Aqua), Cyclopenta siloxane, Clyclohexasiloxane, Isododecane, Alcohol Denat.,Cetyl PEG/PPG-10/1 Dimethicone, C12-15 Alkyl Benzoate, Acrylates/Dimethicone Copolymer,Silica, Acrylates Copolymer, Sodium Myristoyl Glutamate, Sorbitan Sesquioleate,Polyhydroxystearic Acid, Disteardimonium Hectorite, Caprylyl Glycol, Aluminum Oxide,Stearic Acid, Propylene Glycol, Propylene Carbonate, Tetrasodium EDTA, Methylisothiazolinone,May Contain: Iron Oxides, Titanium Dioxide, Triethoxycaprylylsilane

* Please review the disclaimer below.