NDC 62839-2734 Nu Skin Tri-phasic White System

Avobenzone, Octinoxate, And Octisalate

NDC Product Code 62839-2734

NDC 62839-2734-1

Package Description: 1 KIT in 1 CARTON * 125 mL in 1 BOTTLE, PLASTIC * 30 mL in 1 BOTTLE, PUMP * 30 mL in 1 JAR * 100 mL in 1 TUBE * 75 mL in 1 BOTTLE, PLASTIC (62839-0273-1)

NDC Product Information

Nu Skin Tri-phasic White System with NDC 62839-2734 is a a human over the counter drug product labeled by Nse Products, Inc.. The generic name of Nu Skin Tri-phasic White System is avobenzone, octinoxate, and octisalate. The product's dosage form is kit and is administered via form.

Labeler Name: Nse Products, Inc.

Dosage Form: Kit - A packaged collection of related material.

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.

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 (UNII: NMQ347994Z)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SQUALANE (UNII: GW89575KF9)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALLANTOIN (UNII: 344S277G0Z)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Nse Products, Inc.
Labeler Code: 62839
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 04-01-2013 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.

Nu Skin Tri-phasic White System Product Label Images

Nu Skin Tri-phasic White System 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

Nu Skin® Tri-Phasic White® Day Milk Lotion Broad Spectrum SPF 15Drug Facts

Active Ingredient

Avobenzone (2.4%), Octinoxate (7.4%), Octisalate (3.0%)

Purpose

Sunscreen

Use

  • Helps prevent sunburn. Higher SPF gives more sunburn protection.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.

Warnings

  • For external use only.

Otc - Do Not Use

  • Do not use on damaged or broken skin.

Otc - Stop Use

  • Stop use and ask a doctor if rash occurs.

Otc - When Using

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

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

  • Use in the morning after applying Tri-Phasic White® Essence. Apply liberally to face and neck.Sunprotection 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-sleeved shirts, pants, hats, and sunglasses.Apply liberally 15 minutes before sun exposure.Use a water resistant sunscreen if swimming or sweating.Reapply at least every 2 hours.Children under 6 months: Ask a doctor.

Inactive Ingredients

Water (Aqua), Cyclomethicone, Butylene Glycol, Bis-PEG/PPG-16/16 PEG/PPG-16/16 Dimethicone, Octyldodecyl Neopentanoate, Glycerin, Squalane, Hexapeptide-2, Caprylic/ Capric Triglyceride, Phenyl Trimethicone, Tocopheryl Acetate, Allantoin, Phospholipids, Xanthan Gum, Dimethiconol, Dextran, Polyphosphorylcholine Glycol Acrylate, Polysorbate 80, PEG-8, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 60, Aminomethyl Propanol, Disodium EDTA, Fragrance (Parfum), Phenoxyethanol, Chlorphenesin, Methylparaben, Benzoic Acid.

Other Information

  • Protect this product from excessive heat and direct sun.

Questions?

1-888-742-7626

* Please review the disclaimer below.