NDC 62839-6201 Nu Skin Sunright Lip Balm Broad Spectrum Spf 15

Octinoxate, Avobenzone, And Octocrylene

NDC Product Code 62839-6201

NDC CODE: 62839-6201

Proprietary Name: Nu Skin Sunright Lip Balm Broad Spectrum Spf 15 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, Avobenzone, And Octocrylene 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

  • 62839 - Nse Products, Inc.
    • 62839-6201 - Nu Skin Sunright Lip Balm Broad Spectrum Spf 15

NDC 62839-6201-1

Package Description: 1 TUBE in 1 POUCH > 15 mL in 1 TUBE

NDC Product Information

Nu Skin Sunright Lip Balm Broad Spectrum Spf 15 with NDC 62839-6201 is a a human over the counter drug product labeled by Nse Products, Inc.. The generic name of Nu Skin Sunright Lip Balm Broad Spectrum Spf 15 is octinoxate, avobenzone, and octocrylene. The product's dosage form is stick and is administered via topical form.

Labeler Name: Nse Products, Inc.

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

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.

Nu Skin Sunright Lip Balm Broad Spectrum Spf 15 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 75 mg/mL
  • AVOBENZONE 30 mg/mL
  • OCTOCRYLENE 27.9 mg/mL

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.

  • CASTOR OIL (UNII: D5340Y2I9G)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • CERESIN (UNII: Q1LS2UJO3A)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • ETHYL VANILLIN (UNII: YC9ST449YJ)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • WATER (UNII: 059QF0KO0R)
  • CHLORELLA VULGARIS (UNII: RYQ4R60M02)

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: 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: 07-01-2014 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 Sunright Lip Balm Broad Spectrum Spf 15 Product Label Images

Nu Skin Sunright Lip Balm Broad Spectrum Spf 15 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 Ingredient

Avobenzone 3.0 %, Octinoxate 7.5%, Octocrylene 2.79%

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 - 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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • 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.Reapply at least every two hours.Use a water resistant sunscreen if swimming or sweating.Children under 6 months: Ask a doctor.

Inactive Ingredients

Ricinus Communis (Castor) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Beeswax, Euphorbia Cerifera (Candelilla) Wax, Ozokerite, Polyethylene, Caprylic/Capric Triglyceride, Octyldodecyl Neopentanoate, Flavor (Aroma), Glycine Soja (Soybean) Oil, Ethyl Vanillin, Chlorella Vulgaris Extract, Tocopherol, Tocopheryl Acetate, Zea Mays (Corn) Starch, Silica, Water (Aqua), Ethylhexylglycerin, Phenoxyethanol.

Other Information

  • Protect this product from excessive heat and direct sun.

Questions?

1-888-742-7626

* Please review the disclaimer below.