NDC 73759-020 Dal Cara Tone Up Sun Base

Octinoxate, Octisalate, Octocrylene, Ensulizole, Titanium Dioxide

NDC Product Code 73759-020

NDC 73759-020-02

Package Description: 1 CONTAINER in 1 CARTON > 40 g in 1 CONTAINER (73759-020-01)

NDC Product Information

Dal Cara Tone Up Sun Base with NDC 73759-020 is a a human over the counter drug product labeled by E&b. The generic name of Dal Cara Tone Up Sun Base is octinoxate, octisalate, octocrylene, ensulizole, titanium dioxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: E&b

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.

Dal Cara Tone Up Sun Base 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 2.8 g/40g
  • OCTISALATE 2 g/40g
  • OCTOCRYLENE 1.2 g/40g
  • ENSULIZOLE 1.2 g/40g
  • TITANIUM DIOXIDE .98 g/40g

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)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)

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: E&b
Labeler Code: 73759
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: 03-01-2020 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.

Dal Cara Tone Up Sun Base Product Label Images

Dal Cara Tone Up Sun Base 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%Ethylhexyl Salicylate 5.0%Octocrylene 3.0%Phenylbenzimidazole Sulfonic Acid 3.0%Titanium Dioxide 2.46%

Purpose

Purpose: Sunscreen

Warnings

Warnings:1)After or while using the cosmetic product, if redness, swelling, itchiness, or any other similar symptom or discomfort arises upon contact with direct sunline, please consult a healthcare provider before using any further2)Avoid using on wounded areas3)Important notes for storage and handlinga) Store at places where children cannot reachb) Store at places with no direct sunlight4)Avoid contact with eye

Description

Uses:Physical sunscreen and chemical sunscreen combined to ensure UVprotection and smooth textureDirections:Apply appropriate amount onto face and patQuestions:+8215224401

Inactive Ingredient

Inactive ingredients:Water, Propanediol, Pentylene Glycol, Ethylhexyl Isononanoate, Niacinamide, Potassium Cetyl Phosphate, Triethanolamine, Cyclopentasiloxane, Cetearyl Alcohol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Glycerin, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, Glyceryl Stearate, Dimethicone, PEG-100 Stearate, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Lavandula Angustifolia (Lavender) Oil, Sophora Japonica Fruit Extract, Sorbitan Isostearate, Stearic Acid, Caprylyl Glycol, Decyl Glucoside, Allantoin, Pullulan, Carbomer, Xanthan Gum, Ethylhexylglycerin, Hydrogenated Lecithin, Adenosine, Disodium EDTA, Triethoxycaprylylsilane, Propylene Glycol, Bacillus/Soybean Ferment Extract, Butylene Glycol, 1,2-Hexanediol, Alteromonas Ferment Extract

* Please review the disclaimer below.