NDC 73695-020 Xoul 60days Sun

Diethylamino Hydroxybenzoyl Hexyl Benzoate, Ethylhexyl Triazone

NDC Product Code 73695-020

NDC 73695-020-02

Package Description: 3 CONTAINER in 1 CARTON > 20 mL in 1 CONTAINER (73695-020-01)

NDC Product Information

Xoul 60days Sun with NDC 73695-020 is a a human over the counter drug product labeled by Crossj. The generic name of Xoul 60days Sun is diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl triazone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Crossj

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.

Xoul 60days Sun 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.

  • DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE .6 g/20mL
  • ETHYLHEXYL TRIAZONE .4 g/20mL

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)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)

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: Crossj
Labeler Code: 73695
Marketing Category: UNAPPROVED DRUG OTHER - 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.

Xoul 60days Sun Product Label Images

Xoul 60days Sun 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: Diethylamino Hydroxybenzoyl Hexyl Benzoate 3.0%, Ethylhexyl Triazone 2.0%

Inactive Ingredient

Inactive ingredients:Water, Dicaprylyl Carbonate, Dibutyl Adipate, Butylene Glycol, Hydrogenated Polyisobutene, Glycerin, 1,2-Hexanediol, Niacinamide, Polyglyceryl-3 Methylglucose Distearate, Silica, Cetearyl Olivate, Cetearyl Alcohol, Sorbitan Olivate, Glyceryl Stearate SE, Methyl Glucose Sesquistearate, Sorbitan Stearate, Citrus Aurantium Dulcis (Orange) Oil, Disodium EDTA, Cinnamomum Camphora (Camphor) Bark Oil, Adenosine, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Sodium Hyaluronate, Elettaria Cardamomum Seed Oil, Lavandula Hybrida Oil, Pelargonium Graveolens Flower Oil, Ethylhexylglycerin, Tocopherol, Acetyl Hexapeptide-8, Copper Tripeptide-1, Palmitoyl Pentapeptide-4

Purpose

Purpose: Sunscreen

Warnings

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

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Uses

Uses: XOUL 60 days sun cream complements sun cream’s weakness, which weakens UV protection effects after opening product. Protect your skin with fresh suncream every time!

Directions

Directions: Put a desired amount of sun cream on your face or body in the last step of skin care. You can carry them wherever you go and put occasionally whenever you need it.

* Please review the disclaimer below.