NDC 72839-029 Spf 30 Sunscreen Canisun

Avobenzone 3%, Homosalate 8%, Octisalate 5%, Octocrylene 3%

NDC Product Code 72839-029

NDC Code: 72839-029

Proprietary Name: Spf 30 Sunscreen Canisun 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 3%, Homosalate 8%, Octisalate 5%, Octocrylene 3% 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

  • 72839 - Derma Care Research Labs, Llc
    • 72839-029 - Spf 30 Sunscreen

NDC 72839-029-03

Package Description: 89 mL in 1 TUBE

NDC Product Information

Spf 30 Sunscreen Canisun with NDC 72839-029 is a a human over the counter drug product labeled by Derma Care Research Labs, Llc. The generic name of Spf 30 Sunscreen Canisun is avobenzone 3%, homosalate 8%, octisalate 5%, octocrylene 3%. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Derma Care Research Labs, Llc

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Spf 30 Sunscreen Canisun 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 5 g/100mL
  • AVOBENZONE 3 g/100mL
  • HOMOSALATE 8 g/100mL
  • OCTOCRYLENE 3 g/100mL

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.

  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • CANNABIDIOL (UNII: 19GBJ60SN5)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
  • ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • TRIDECETH-6 (UNII: 3T5PCR2H0C)
  • TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
  • VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • MONOSODIUM DL-GLUTAMATE (UNII: LX3YQ006AP)
  • STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
  • GLYCOLIC ACID (UNII: 0WT12SX38S)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • N-ACETYLGLUCOSAMINE (UNII: V956696549)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • BANANA (UNII: 4AJZ4765R9)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SQUALANE (UNII: GW89575KF9)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • CURDLAN (UNII: 6930DL209R)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
  • EDETIC ACID (UNII: 9G34HU7RV0)

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: Derma Care Research Labs, Llc
Labeler Code: 72839
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: 06-14-2019 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: 12-31-2020 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.

Spf 30 Sunscreen Canisun Product Label Images

Spf 30 Sunscreen Canisun 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%, Octisalate 5%, Octocrylene 3%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

Warnings

For external use only.
Do not use on damaged or broken skin.
When using this product keep out of eyes. Rinse eyes with water to remove.
Stop use and ask a doctor if rash occurs.

Keep Out Of Reach Of Children.

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

Directions

  • Apply liberally 15 minutes before sun exposure. Reapply:after 80 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hoursSun protection measures: spending time n the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measure including:
  • Limit time in the sun, especially from 10 am to 2 pmwear long-sleeved shirts, pants, hats, and sunglasses.Children under 6 months: ask a doctor.

Inactive Ingredients

1,2 Hexanediol, Acetyl Glucosamine, Behenyl Alcohol, Beta-Glucan, BHT, Butyloctyl Salicylate, Cannabidiol, Caprylyl Methicone, Diethylhexyl 2,6-Naphthalate, Dimethicone, Dimethyl Capramide, Disodium EDTA, Ethylhexyl Stearate, Ethylhexylglycerin, Fragrance, Glycerin, Glyceryl Stearate, Glycolic Acid, Hydrated Silica, Hydrogenated Lecithin, Levan (Fructan), Musa Sapientum (Banana) Fruit Extract, PEG-100 Stearate, Phenoxyethanol, Sodium Hyaluronate, Sodium Polyacrylate, Sodium Polyglutamate, Squalane, Styrene/Acrylates Copolymer, Trideceth-6, Trimethylsiloxysilicate, VP/Hexadecene Copolymer, Water, Xanthan Gum.

* Please review the disclaimer below.

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