NDC 67597-001 Nudist Lip Butter Afterglow

Zinc Oxide

NDC Product Code 67597-001

NDC 67597-001-01

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 2 g in 1 BOTTLE, PLASTIC

NDC Product Information

Nudist Lip Butter Afterglow with NDC 67597-001 is a a human over the counter drug product labeled by Royal Cosmetics Corporation. The generic name of Nudist Lip Butter Afterglow is zinc oxide. The product's dosage form is stick and is administered via topical form.

Labeler Name: Royal Cosmetics Corporation

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.

Nudist Lip Butter Afterglow 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.

  • ZINC OXIDE 10 g/100g

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.

  • ACACIA DECURRENS FLOWER (UNII: 8PHF3LSM61)
  • TRIBEHENIN (UNII: 8OC9U7TQZ0)
  • JOJOBA OIL (UNII: 724GKU717M)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • LINOLEIC ACID (UNII: 9KJL21T0QJ)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • SUCCINIC ACID (UNII: AB6MNQ6J6L)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • RASPBERRY SEED OIL (UNII: 9S8867952A)
  • CARROT SEED OIL (UNII: 595AO13F11)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • MENTHA SPICATA OIL (UNII: C3M81465G5)
  • VANILLA BEAN (UNII: Q74T35078H)

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: Royal Cosmetics Corporation
Labeler Code: 67597
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: 02-14-2020 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’.

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Nudist Lip Butter Afterglow Product Label Images

Nudist Lip Butter Afterglow 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

Active Ingredient

Zinc Oxide 10%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.

Warnings

  • For external use only.Do not use on damaged or broken skin.Stop use and ask doctor if skin rash occurs.When using this product keep out of eyes. Rinse with water to remove.  Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

Apply liberally to the lips. 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 the sun, especially from 10 a.m. – 2 p.m.• Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

Castor Isostearate Succinate, Acacia Decurrens/Jojoba/Sunflower Seed Wax/Polyglyceryl-Esters, Tribehenin, Oleic/Linoleic/LonolenicPolyglycarides, Euphorbia Cerifera (Candelila) Wax*, Simmondsia Chinensis (Jojoba) Oil*, Helianthus Annuus (Sunflower) Seed Oil*,Rubus Idaeus (Red Raspberry) Seed Oil*, Daucus Carota Sativa (Carrot) Seed Oil*, Mixed Tocopherols, Camellia Sinensis Leaf Extract*,Mentha Spicata (Spearmint)*, Vanilla Planifolia Fruit*. [± Iron Oxide (CI 77491, 77492, 77499), D & C Red 33 (CI 17200), D&C Red No. (CI15850), Manganese Violet (CI 77742), Mica (CI 77019)*ORGANIC INGREDIENTS

Other Information

Protect this product from excessive heat and direct sun. This is a water reisstant product.

Questions?

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