NDC 69978-0081 Tieso Rapido Plus

Homosalate, Ethylhexyl Salicylate, Titanium Dioxide, Benzalkonium Chloride

NDC Product Code 69978-0081

NDC CODE: 69978-0081

Proprietary Name: Tieso Rapido Plus 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: Homosalate, Ethylhexyl Salicylate, Titanium Dioxide, Benzalkonium Chloride 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

  • 69978 - Atec Co., Ltd.

NDC 69978-0081-1

Package Description: 1 BOTTLE, SPRAY in 1 BOX > 80 mL in 1 BOTTLE, SPRAY

NDC Product Information

Tieso Rapido Plus with NDC 69978-0081 is a a human over the counter drug product labeled by Atec Co., Ltd.. The generic name of Tieso Rapido Plus is homosalate, ethylhexyl salicylate, titanium dioxide, benzalkonium chloride. The product's dosage form is spray and is administered via topical form.

Labeler Name: Atec Co., Ltd.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Tieso Rapido Plus 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.

  • HOMOSALATE 4 g/80mL
  • BENZALKONIUM CHLORIDE .032 g/80mL
  • TITANIUM DIOXIDE 1.68 g/80mL
  • OCTISALATE 3.6 g/80mL

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.

  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • LEPIDIUM MEYENII ROOT (UNII: HP7119212T)
  • WATER (UNII: 059QF0KO0R)
  • CYCLOMETHICONE (UNII: NMQ347994Z)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • DIOSCOREA JAPONICA ROOT (UNII: I43FCF3356)
  • VIOLA MANDSHURICA FLOWER (UNII: 46MR945M6X)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • ENSULIZOLE (UNII: 9YQ9DI1W42)
  • C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
  • DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • LAMINARIA JAPONICA (UNII: WE98HW412B)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • BEMOTRIZINOL (UNII: PWZ1720CBH)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ULMUS DAVIDIANA ROOT (UNII: URQ79U8261)

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.
  • 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: Atec Co., Ltd.
Labeler Code: 69978
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: 10-22-2020 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.

Tieso Rapido Plus Product Label Images

Tieso Rapido Plus 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

Active ingredients PurposesHomosalate 5.00 % .......................................... sunscreen

Ethylhexyl Salicylate 4.5% .................................sunscreen

Titanium Dioxide 2.1 % ......................................sunscreen

Benzalkonium Chloride 0.04 % .......................antibacterial

Inactive Ingredient

Inactive ingredients Water, Dicaprylyl Carbonate, Alcohol, Cyclomethicone, Phenylbenzimidazole Sulfonic Acid, Lepidium Meyenii Root Extract, Glycerin, 1,2-Hexanediol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Diethylamino Hydroxybenzoyl Hexyl Benzoate, C13-16 Isoparaffin, PEG-10 Dimethicone, Sodium Chloride, Heptyl Undecylenate, Sodium Hydroxide, Aloe Barbadensis Leaf Extract, Dioscorea Japonica Root Extract, Laminaria Japonica Extract, Ulmus Davidiana Root Extract, Viola Mandshurica Flower Extract, Stearic acid, Aluminum Hydroxide, Butylene Glycol, Disodium EDTA, Fragrance

* Please review the disclaimer below.