NDC 79950-002 Bondi Sands Toasted Coconut Lip Balm With Spf 50 Sunscreen

Avobenzone, Homosalate, Octocrylene

NDC Product Code 79950-002

NDC CODE: 79950-002

Proprietary Name: Bondi Sands Toasted Coconut Lip Balm With Spf 50 Sunscreen 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: Avobenzone, Homosalate, 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

  • 79950 - Bondi Sands (usa) Inc.
    • 79950-002 - Bondi Sands Toasted Coconut Lip Balm With Spf 50 Sunscreen

NDC 79950-002-01

Package Description: 1 TUBE, WITH APPLICATOR in 1 CARTON > 10 g in 1 TUBE, WITH APPLICATOR

NDC Product Information

Bondi Sands Toasted Coconut Lip Balm With Spf 50 Sunscreen with NDC 79950-002 is a a human over the counter drug product labeled by Bondi Sands (usa) Inc.. The generic name of Bondi Sands Toasted Coconut Lip Balm With Spf 50 Sunscreen is avobenzone, homosalate, octocrylene. The product's dosage form is lipstick and is administered via topical form.

Labeler Name: Bondi Sands (usa) Inc.

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.

Bondi Sands Toasted Coconut Lip Balm With Spf 50 Sunscreen 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.

  • AVOBENZONE 30 mg/g
  • OCTOCRYLENE 40 mg/g
  • HOMOSALATE 80 mg/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.

  • HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • COCO-GLYCERIDES (UNII: ISE9I7DNUG)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • JOJOBA OIL (UNII: 724GKU717M)
  • TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
  • PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
  • SACCHARIN (UNII: FST467XS7D)
  • ANISYL ALCOHOL (UNII: 7N6XGV3U49)
  • YELLOW WAX (UNII: 2ZA36H0S2V)

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: Bondi Sands (usa) Inc.
Labeler Code: 79950
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.

Bondi Sands Toasted Coconut Lip Balm With Spf 50 Sunscreen Product Label Images

Bondi Sands Toasted Coconut Lip Balm With Spf 50 Sunscreen 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 Ingredients

Avobenzone 3%, Homosalate 8%, Octocrylene 4%

Purpose

Sunscreen

Uses

  • Helps prevent sunburnHigher SPF gives more sunburn protection

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or ealy skin aging.For external use only.

Do Not Use

On damaged or broken skin.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use And Ask A Doctor

If rash or irritation develops and lasts.

Directions

  • Apply liberally 15 minutes before sun exposure.Reapply at least every 2 hours.Use a water resistant sunscreen if swimming or sweating.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.Children under 6 months: Ask a doctor.

Other Information

  • Protect the product in this container from excessive heat and direct sun.You may report a serious adverse reaction to 888-266-0772; Monday – Friday, 9 am – 5 pm.

Inactive Ingredients

Ricinus Communis (Castor) Seed Oil, Octyldodecanol, Synthetic Beeswax, Microcrystalline Wax/Cera Microcristallina/Cire microcrystalline, Hydrogenated Polydecene, Cetyl Palmitate, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Cocoglycerides, Simmondsia Chinensis (Jojoba) Seed Oil, Flavor/Aroma, Triacontanyl PVP, PEG-30 Dipolyhydroxystearate, Tocopheryl Acetate, Saccharin, Anise Alcohol.

Questions?

888-266-0772 or visit bondisands.com

Company Information

Made in Australia.Distributed by Bondi Sands USAWilmingon, 19808, DE.bondisands.com

Product Packaging

Bondi sandsThe Australian tanLIP BALMwithSPF 50TOASTED COCONUTSUNSCREENLIP CAREAustralian MadeNet wt. 0.35 OZ. (10g)

* Please review the disclaimer below.