NDC 70803-250 Active Argan 365 Spf 30 Broad Spectrum Activated Argan Complex

Zinc Oxide

NDC Product Code 70803-250

NDC Code: 70803-250

Proprietary Name: Active Argan 365 Spf 30 Broad Spectrum Activated Argan Complex 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: Zinc Oxide 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

  • 70803 - Siborg Llc
    • 70803-250 - Active Argan 365 Spf 30 Broad Spectrum Activated Argan Complex

NDC 70803-250-01

Package Description: 1 BOTTLE in 1 BOX > 50 mL in 1 BOTTLE

NDC Product Information

Active Argan 365 Spf 30 Broad Spectrum Activated Argan Complex with NDC 70803-250 is a a human over the counter drug product labeled by Siborg Llc. The generic name of Active Argan 365 Spf 30 Broad Spectrum Activated Argan Complex is zinc oxide. The product's dosage form is oil and is administered via topical form.

Labeler Name: Siborg Llc

Dosage Form: Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.

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.

Active Argan 365 Spf 30 Broad Spectrum Activated Argan Complex 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 220 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.

  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
  • COCO-CAPRYLATE (UNII: 4828G836N6)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)
  • HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
  • TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
  • MICA (UNII: V8A1AW0880)
  • WATER (UNII: 059QF0KO0R)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: Siborg Llc
Labeler Code: 70803
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: 03-16-2019 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.

Active Argan 365 Spf 30 Broad Spectrum Activated Argan Complex Product Label Images

Active Argan 365 Spf 30 Broad Spectrum Activated Argan Complex 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

Zinc oxide 22%

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

Warnings

For external use only

Do Not Use

On damaged or broken skin

When Using This Product

Keep out of eyes. Rinse 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 and evenly 15 minutes before sun exposureReapply at least every 2 hoursUse a water resistant sunscreen if swimming or sweatingSun 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 sunglassesChildren under 6 months of age: Ask a doctor

Other Information

Dicaprylyl carbonate, isononyl isononanoate, coco-caprylate, C12-15 alkyl benzoate, ethylhexyl palmitate, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, magnesium stearate, argania spinosa kernel oil, tocopherol, caesalpinia spinosa fruit pod extract, helianthus annuus (sunflower) sprout extract, sodium hyaluronate, tocopheryl acetate, maltodextrin, phenethyl alcohol, polyhydroxystearic acid, trihydroxystearin, mica, aqua (water), ethylhexylglycerin, sodium benzoate, iron oxides (CI 77499), titanium dioxide (CI 77891)

* Please review the disclaimer below.

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