NDC 13734-157 Nars Smooth And Protect Primer

Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone

NDC Product Code 13734-157

NDC Code: 13734-157

Proprietary Name: Nars Smooth And Protect Primer 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: Avobenzone, Homosalate, Octisalate, Octocrylene, And 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

  • 13734 - Nars Cosmetics
    • 13734-157 - Nars Smooth And Protect Primer

NDC 13734-157-60

Package Description: 1 TUBE in 1 CARTON > 30 mL in 1 TUBE

NDC 13734-157-61

Package Description: 1 mL in 1 PACKET

NDC Product Information

Nars Smooth And Protect Primer with NDC 13734-157 is a a human over the counter drug product labeled by Nars Cosmetics. The generic name of Nars Smooth And Protect Primer is avobenzone, homosalate, octisalate, octocrylene, and oxybenzone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Nars Cosmetics

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Nars Smooth And Protect Primer 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.

  • AVOBENZONE 741.7 mg/30mL
  • HOMOSALATE 2967 mg/30mL
  • OCTISALATE 1483.5 mg/30mL
  • OCTOCRYLENE 1483.5 mg/30mL
  • OXYBENZONE 1483.5 mg/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.

  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
  • HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
  • HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
  • VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • WATER (UNII: 059QF0KO0R)
  • LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
  • DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • MICA (UNII: V8A1AW0880)
  • EDETATE TRISODIUM (UNII: 420IP921MB)
  • STANNIC OXIDE (UNII: KM7N50LOS6)

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: Nars Cosmetics
Labeler Code: 13734
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: 12-01-2016 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: 12-31-2019 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.

Nars Smooth And Protect Primer Product Label Images

Nars Smooth And Protect Primer 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

Active Ingredients

Avobenzone 2.5%Homosalate 10%Octisalate 5%Octocrylene 5%Oxybenzone 5%

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

  • For sunscreen use:apply liberally 15 minutes before sun exposureuse a water resistant sunscreen if swimming or sweatingreapply at least 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 of 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: Ask a doctor

Inactive Ingredients

Dimethicone ∙ Methyl Trimethicone ∙ Dimethicone/Vinyl Dimethicone Crosspolymer ∙ Dimethicone Crosspolymer ∙ Disteardimonium Hectorite ∙ Polymethylsilsesquioxane ∙ Silica ∙ Trimethylsiloxysilicate ∙ HDI/Trimethylol Hexyllactone Crosspolymer ∙ PEG-10 Dimethicone ∙ PEG/PPG-19/19 Dimethicone ∙ Hydrogenated Polyisobutene ∙ Tocopherol ∙ Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer ∙ VP/Eicosene Copolymer ∙ Dipropylene Glycol ∙ Water ∙ Lavandula Angustifolia (Lavender) Extract ∙ Dimethylmethoxy Chromanol ∙ Trisodium EDTA ∙ Tin Oxide ∙ Mica ∙ Titanium Dioxide ∙

Other Information

  • Protect this product in this container from excessive heat and direct sun

* Please review the disclaimer below.

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