NDC 70630-0014 Coconut Lip Balm Spf15

Octisalate, Homosalate, Octocrylene, Avobenzone

  1. Labeler Index
  2. Bali Body Pty Ltd
  3. NDC: 70630-0014 Coconut Lip Balm Spf15

NDC Product Code 70630-0014

NDC CODE: 70630-0014

Proprietary Name: Coconut Lip Balm Spf15 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, Homosalate, Octocrylene, Avobenzone 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

  • 70630 - Bali Body Pty Ltd

NDC 70630-0014-1

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

NDC Product Information

Coconut Lip Balm Spf15 with NDC 70630-0014 is a a human over the counter drug product labeled by Bali Body Pty Ltd. The generic name of Coconut Lip Balm Spf15 is octisalate, homosalate, octocrylene, avobenzone. The product's dosage form is lipstick and is administered via topical form.

Labeler Name: Bali Body Pty Ltd

Dosage Form: Lipstick - A waxy solid, usually colored cosmetic, in stick form for the lips.

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.

Coconut Lip Balm Spf15 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 28 mg/mL
  • HOMOSALATE 28 mg/mL
  • OCTOCRYLENE 28 mg/mL
  • AVOBENZONE 20 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)
  • HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • WATER (UNII: 059QF0KO0R)
  • JOJOBA OIL (UNII: 724GKU717M)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • VANILLA PLANIFOLIA OIL (UNII: 0A3F415158)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • DAUCUS CAROTA SUBSP. SATIVUS SEED (UNII: 9M6AAX381U)
  • CHAMOMILE (UNII: FGL3685T2X)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • STEVIOSIDE (UNII: 0YON5MXJ9P)
  • POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • ALCOHOL (UNII: 3K9958V90M)
  • ANNATTO (UNII: 6PQP1V1B6O)

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: Bali Body Pty Ltd
Labeler Code: 70630
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: 01-01-2021 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.

Coconut Lip Balm Spf15 Product Label Images

Coconut Lip Balm Spf15 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

Directions:

Apply to clean lips for long lasting hydration and a dewy glow

Warnings:

For external use only. Keep out of direct sunlight or other sources of strong light. Product to be stored beteen 5-28°C. Discontinues use if irritation occurs. Subtle variations in appearance and texture of this product in no way affect its integrity.

Keep Out Of Reach Of Children.

Please refer to balibodyco.com for further sun-safety instructions.

Use:

Helps prevent sunburn, If used with other sun protection measures decreases the risk of skin cancer.

Active Ingredients:

Octisalate 2.8%


Homosalate 2.8%


Octocrylene 2.8%


Avobenzone 2%

Purpose:

Sunsreen

Inactive Ingredients:

Ricinus Communis (Castor) Seed Oil, Hydrogenated Soybean Oil, Cocos Nucifera (Coconut) Oil, Theobroma Cacao (Cocoa) Seed Butter, Euphorbia Cerifera (candelilla) Wax, Water (Aqua), Simmondsia Chinesis (Jojoba) Seed Oil, Glycine Soja (Soybean) Oil, Vanilla Planifolia Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Daucus Carota Sativa (Carrot) Seed Extract, Chamomilla Recutita (Matricaria) Flower Extract, Tocopherol, Xanthan Gum, Flavor (Aroma), Stevioside, Polyglyceryl-3 Diisostearate, Potassium Sorbate, Citric Acid, Sodium Hydroxide, Alcohol, Annatto(CI 75120)

* Please review the disclaimer below.