NDC 13734-160 Nars Afterglow Lip Balm Clean Cut

Octinoxate

NDC Product Code 13734-160

NDC Code: 13734-160

Proprietary Name: Nars Afterglow Lip Balm Clean Cut Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.


Code Structure
  • 13734 - Nars Cosmetics
    • 13734-160 - Nars Afterglow Lip Balm Clean Cut

NDC 13734-160-20

Package Description: 1 CARTRIDGE in 1 CARTON > 3 g in 1 CARTRIDGE

NDC Product Information

Nars Afterglow Lip Balm Clean Cut with NDC 13734-160 is a a human over the counter drug product labeled by Nars Cosmetics. The generic name of Nars Afterglow Lip Balm Clean Cut is octinoxate. The product's dosage form is stick and is administered via topical form.

Labeler Name: Nars Cosmetics

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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 Afterglow Lip Balm Clean Cut Active Ingredient(s)

Additional informationCallout TooltipWhat 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 222 mg/3g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
  • TRIISOSTEARIN (UNII: 71503RH8KG)
  • SQUALANE (UNII: GW89575KF9)
  • BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
  • DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • TRIMETHYLOLPROPANE TRIETHYLHEXANOATE (UNII: B952ZGW1IL)
  • LAURYL PIDOLATE (UNII: 29C5O2BJYA)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • JOJOBA OIL (UNII: 724GKU717M)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • METHICONE (20 CST) (UNII: 6777U11MKT)
  • TETRADECENE (UNII: FW23481S7S)
  • STANNIC OXIDE (UNII: KM7N50LOS6)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-01-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Afterglow Lip Balm Clean Cut Product Label Images

Nars Afterglow Lip Balm Clean Cut 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

Octinoxate 7.4%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.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 exposureuse a water resistant sunscreen if swimming or sweatingreapply at least every 2 hours children under 6 months: Ask a doctor

Inactive Ingredients

Hydrogenated Polyisobutene ∙ Triisostearin ∙ Squalane ∙ Bis-Diglyceryl Polyacyladipate-2 ∙ Diphenylsiloxy Phenyl Trimethicone ∙ Polyethylene ∙ Microcrystalline Wax ∙ Diisostearyl Malate ∙ Cocos Nucifera (Coconut) Oil ∙ Tocopherol ∙ Gardenia Taitensis Flower Extract ∙ Tocopheryl Acetate ∙ Simmondsia Chinensis (Jojoba) Seed Oil ∙ Punica Granatum Flower Extract ∙ Polysilicone-2 ∙ Glyceryl Diisostearate ∙ Simethicone ∙ Trimethylolpropane Triethylhexanoate ∙ Lauryl PCA ∙ Methicone ∙ Tetradecene ∙ Tin Oxide ∙ BHT ∙ Silica ∙ Aluminum Hydroxide ∙ Phenoxyethanol ∙ Titanium Dioxide ∙ Iron Oxides ∙ Red 7 Lake ∙

Other Information

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

* Please review the disclaimer below.

Previous Code
13734-159
Next Code
13811-606