NDC 73020-070 Papa Recipe Bombee Moist Sun Essence

Octinoxate, Homosalate, Octisalate, Titanium Dioxide

NDC Product Code 73020-070

NDC CODE: 73020-070

Proprietary Name: Papa Recipe Bombee Moist Sun Essence 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: Octinoxate, Homosalate, Octisalate, Titanium Dioxide 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

  • 73020 - Costory Co., Ltd
    • 73020-070 - Papa Recipe Bombee Moist Sun Essence

NDC 73020-070-02

Package Description: 1 CONTAINER in 1 CARTON > 50 mL in 1 CONTAINER (73020-070-01)

NDC Product Information

Papa Recipe Bombee Moist Sun Essence with NDC 73020-070 is a a human over the counter drug product labeled by Costory Co., Ltd. The generic name of Papa Recipe Bombee Moist Sun Essence is octinoxate, homosalate, octisalate, titanium dioxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Costory Co., Ltd

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Papa Recipe Bombee Moist Sun Essence 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.

  • OCTINOXATE 3.5 g/50mL
  • HOMOSALATE 1.5 g/50mL
  • OCTISALATE 1.5 g/50mL
  • TITANIUM DIOXIDE .74 g/50mL

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.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

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: Costory Co., Ltd
Labeler Code: 73020
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: 02-01-2020 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.

Papa Recipe Bombee Moist Sun Essence Product Label Images

Papa Recipe Bombee Moist Sun Essence 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 Ingredient

Active ingredients:Ethylhexyl Methoxycinnamate 7.0%, Homosalate 3.0%, Ethylhexyl Salicylate 3.0%, Titanium Dioxide 1.49%

Inactive Ingredient

Inactive ingredients:Water, Alcohol, Pentylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Caprylyl Methicone, 1,2-Hexanediol, Glycerin, Isononyl Isononanoate, Ethylhexyl Triazone, Polyglyceryl-3 Methylglucose Distearate, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cyclopentasiloxane, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Stearic Acid, Isohexadecane, Xanthan Gum, Tocopheryl Acetate, Sorbitan Isostearate, Ethylhexylglycerin, Allantoin, Limonene, Polysorbate 80, Sorbitan Oleate, Butylene Glycol, Citrus Limon (Lemon) Peel Oil, Sodium Hyaluronate, Rosa Damascena Flower Extract, Nelumbo Nucifera Flower Extract, Carthamus Tinctorius (Safflower) Flower Extract, Camellia Japonica Flower Extract, Citral, Honey Extract, Propolis Extract, Royal Jelly Extract, Sophora Japonica Fruit Extract, Ethyl Hexanediol, Lavandula Angustifolia (Lavender) Flower Extract, Viola Tricolor Extract, Centaurea Cyanus Flower Extract, Pancratium Maritimum Extract, Caprylyl Glycol

Purpose

Purpose: Sunscreen

Warnings

Warnings:For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. If any adverse reaction occurs, stop using the product and consult with dermatologist if symptoms persist. Do not use on deep puncture wounds, animal bites or serious burns. Replace the cap after use. Keep out of reach of children. Keep out of direct sunlight.

Description

Uses■ Helps prevent skin from excessive exposure to UV rays■ Helps moisturize and refresh your skin that is easy to be dehydrated under the sun for long hours■ Provides a gentle application without greasy or sticky feelingDirections■ For face, apply a dime-sized amount liberally and gently over your entire skin before sun exposure after your ritual daily moisturization.■ For body, apply liberally and uniformly to any exposed areas of your body before sun exposure or long-hour outdoor activities to ensure sun protection.

* Please review the disclaimer below.