NDC 57691-325 Vitamin E Moisture-protect Lip Care Spf 15

Octisalate, Avobenzone, And Octocrylene

NDC Product Code 57691-325

NDC CODE: 57691-325

Proprietary Name: Vitamin E Moisture-protect Lip Care 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: Octisalate, 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

  • 57691 - Buth-na-bodhaige, Inc.,
    • 57691-325 - Vitamin E Moisture-protect Lip Care Spf 15

NDC 57691-325-42

Package Description: 4.2 g in 1 CONTAINER

NDC Product Information

Vitamin E Moisture-protect Lip Care Spf 15 with NDC 57691-325 is a a human over the counter drug product labeled by Buth-na-bodhaige, Inc.,. The generic name of Vitamin E Moisture-protect Lip Care Spf 15 is octisalate, avobenzone, and octocrylene. The product's dosage form is stick and is administered via topical form.

Labeler Name: Buth-na-bodhaige, 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.

Vitamin E Moisture-protect Lip Care 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.

  • OCTISALATE .05 g/g
  • AVOBENZONE .02 g/g
  • OCTOCRYLENE .03 g/g

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)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
  • WHEAT GERM OIL (UNII: 14C97E680P)
  • VANILLA (UNII: Q74T35078H)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • ECHINACEA PURPUREA (UNII: QI7G114Y98)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • SOYBEAN OIL (UNII: 241ATL177A)

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.
  • 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: Buth-na-bodhaige, Inc.,
Labeler Code: 57691
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: 10-31-2020 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.

Vitamin E Moisture-protect Lip Care Spf 15 Product Label Images

Vitamin E Moisture-protect Lip Care 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

Otc - Purpose

Active IngredientsPurposeAvobenzone (2.0% w/w)SunscreenOctisalate (5.0% w/w)SunscreenOctocrylene (3.0% w/w)Sunscreen

Uses

  • Helps prevent sunburn.

Warnings

  • For external use only

Otc - Do Not Use

  • Do not useon damaged or broken skin.

Otc - When Using

  • When using this productkeep out of eyes. Rinse with water to remove.

Otc - Stop Use

  • Stop use and ask a doctor ifrash 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 exposure.Sun 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 value of 15 or higher and other sun protection measures including: limit time in sun especially from 10 a.m. – 2 p.m.wear long-sleeved shirts, pants, hats and sunglasses.reapply this product at least every 2 hours.use water resistant sunscreen if swimming or sweating.children under 6 months of age: ask a doctor.

Other Information

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

Inactive Ingredients

Ricinus Communis (Castor) Seed Oil, Olea Europaea (Olive) Fruit Oil, Beeswax, Hydrogenated Coconut Oil, Euphorbia Cerifera (Candelilla) Wax, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Ammonium Glycyrrhizate, Triticum Vulgare (Wheat) Germ Oil, Vanilla Planifolia Fruit Extract, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Tocopherol, Glycine Soja (Soybean) Oil.

* Please review the disclaimer below.