NDC 70884-409 Tropic Sport Mineral Sunscreen Spf 30

Titanium Dioxide, Zinc Oxide

NDC Product Code 70884-409

NDC Code: 70884-409

Proprietary Name: Tropic Sport Mineral Sunscreen Spf 30 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: Titanium Dioxide, 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

  • 70884 - X3em Brands Llc
    • 70884-409 - Tropic Sport Mineral Sunscreen

NDC 70884-409-03

Package Description: 88 mg in 1 BOTTLE, PLASTIC

NDC Product Information

Tropic Sport Mineral Sunscreen Spf 30 with NDC 70884-409 is a a human over the counter drug product labeled by X3em Brands Llc. The generic name of Tropic Sport Mineral Sunscreen Spf 30 is titanium dioxide, zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: X3em Brands 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.

Tropic Sport Mineral Sunscreen Spf 30 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.

  • TITANIUM DIOXIDE 4.5 mg/100mg
  • ZINC OXIDE 8.6 mg/100mg

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.

  • CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • STEARETH-2 (UNII: V56DFE46J5)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • STEARETH-21 (UNII: 53J3F32P58)
  • PODOCARPUS ELATUS FRUIT (UNII: R4N1M6CZCY)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)
  • MACADAMIA OIL (UNII: 515610SU8C)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • WATER (UNII: 059QF0KO0R)

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: X3em Brands Llc
Labeler Code: 70884
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: 04-08-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 04-08-2020 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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.

Tropic Sport Mineral Sunscreen Spf 30 Product Label Images

Tropic Sport Mineral Sunscreen Spf 30 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

Otc - Active Ingredient

Titanium Dioxide, 4.5%Zinc Oxide, 8.6%

Otc - Purpose

Sunscreen

Indications & Usage

Uses  helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Directions  apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating • immediately after towel drying • at 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 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

Warnings

For external use only

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove

Otc - Stop Use

Stop use and ask a doctor if rash occur

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

Use In Specific Populations

 children under 6 months of age: Ask a doctor

Other Safety Information

Other information  protect the product in this container from excessive heat and direct sun

Inactive Ingredient

Inactive ingredients: Water/Aqua/Eau, Caprylic/Capric Triglyceride, Glycerin, Cetearyl Alcohol, Steareth-2, VP/Hexadecene Copolymer, Steareth-21, Dimethicone, Polyhydroxystearic Acid, Aloe Barbadensis Leaf Extract, Camellia Oleifera Leaf Extract, Pleiogynium Timoriense Fruit Extract, Podocarpus Elatus Fruit Extract, Terminalia Ferdinandiana Fruit Extract, Adansonia Digitata Seed Oil, Astrocaryum Tucuma Seed Butter, Macadamia Ternifolia Seed Oil, Dipotassium Glycyrrhizate, Alumina, Stearic Acid, Sodium Stearoyl Glutamate, Triethoxycaprylylsilane, Propanediol, Caprylhydroxamic Acid, Xanthan Gum, Caprylyl Glycol, Fragrance (Parfum).

Otc - Questions

Questions or comments? Call 1-844-484-2096 or www.tropicsport.com

* Please review the disclaimer below.

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