NDC 79950-003 Bondi Sands Fragrance Free Spf 50 Sunscreen

Avobenzone, Homosalate, Octisalate, Octocrylene

NDC Product Code 79950-003

NDC CODE: 79950-003

Proprietary Name: Bondi Sands Fragrance Free 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, Octisalate, 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.
    • 79950-003 - Bondi Sands Fragrance Free Spf 50 Sunscreen

NDC 79950-003-01

Package Description: 160 g in 1 CAN

NDC Product Information

Bondi Sands Fragrance Free Spf 50 Sunscreen with NDC 79950-003 is a a human over the counter drug product labeled by Bondi Sands (usa) Inc.. The generic name of Bondi Sands Fragrance Free Spf 50 Sunscreen is avobenzone, homosalate, octisalate, octocrylene. The product's dosage form is aerosol, spray and is administered via topical form.

Labeler Name: Bondi Sands (usa) Inc.

Dosage Form: Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.

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 Fragrance Free 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 18 mg/g
  • OCTISALATE 30 mg/g
  • OCTOCRYLENE 60 mg/g
  • HOMOSALATE 90 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.

  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • DIMETHYL ETHER (UNII: AM13FS69BX)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • PEG-15 COCAMINE (UNII: 8L6LB12TSJ)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SACCHARIDE ISOMERATE (UNII: W8K377W98I)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • COCO-GLYCERIDES (UNII: ISE9I7DNUG)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • PEG-40 STEARATE (UNII: ECU18C66Q7)
  • WATER (UNII: 059QF0KO0R)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • CETYL DIMETHICONE 45 (UNII: IK315POC44)
  • CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)

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 Fragrance Free Spf 50 Sunscreen Product Label Images

Bondi Sands Fragrance Free 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 1.8%, Homosalate 9%, Octisalate 3%, Octocrylene 6%

Purpose

Sunscreen

Uses

  • Helps prevent sunburnIf used as directed with other sun protection measures (
  • See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Retains SPF after 80 minutes of activity in the water.

Warnings

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.

When Using This Product

Keep out of eyes. Rinse with water to remove

Stop Use And Ask A Doctor

If rash occurs

Directions

  • Apply liberally 15 minutes before sun exposure.Reapply:after 80 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hours.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

  • Avoid spraying in eyes.Contents under pressure.Do not puncture or incinerate.Do not store at temperature above 120 °F.Use only as directed.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

Dimethyl Ether, Water/Aqua/Eau, Beeswax/Cera Alba/Cire d'abeille, Cetyl Dimethicone, C12-15 Alkyl Benzoate, Cocoglycerides, PEG-15 Cocamine, Glycerin, PEG-40 Stearate, Phenoxyethanol, Saccharide Isomerate, Caprylyl Glycol, Disodium EDTA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Caprylhydroxamic Acid, Tocopheryl Acetate, Aloe Barbadensis Extract, Citric Acid, Sodium Citrate, Potassium Sorbate, Sodium Benzoate.

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 tanBROAD SPECTRUMSPF 50VERY WATER RESISTANT 80 MINUTESFRAGRANCE FREESUNSCREEN SPRAYREEF FRIENDLY72HR HYDRATIONSUITABLE FOR SENSITIVE SKINAustralian MadeNet wt. 5.64 OZ. (160g)

* Please review the disclaimer below.