NDC 70477-040 Mongdies Excellent Sun Cushion

Zinc Oxide, Titanium Dioxide

NDC Product Code 70477-040

NDC 70477-040-02

Package Description: 1 CONTAINER in 1 CARTON > 12 g in 1 CONTAINER (70477-040-01)

NDC Product Information

Mongdies Excellent Sun Cushion with NDC 70477-040 is a a human over the counter drug product labeled by 360perspective Inc.. The generic name of Mongdies Excellent Sun Cushion is zinc oxide, titanium dioxide. The product's dosage form is powder and is administered via topical form.

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

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.

Mongdies Excellent Sun Cushion 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.


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)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)

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: 360perspective Inc.
Labeler Code: 70477
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: 09-01-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Mongdies Excellent Sun Cushion Product Label Images

Mongdies Excellent Sun Cushion 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

Zinc Oxide 11.52%Titanium Dioxide 7.03%

Purpose

Sunscreen

Warnings

For external use only. If skin irritation occurs or increases, discontinue use and consult a physician. Keep out of reach of children. Avoid direct sunlight.

Keep Out Of Reach Of Children

Keep out of reach of children.

Uses

An inorganic hypoallergenic cushion type sun screen with moisturizing and skin protection effects.

Directions

Evenly apply to areas when sun protection is required.

Other Information

Avoid direct sunlight.

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Caprylyl Methicone, Butyloctyl Salicylate, Glycerin, Diphenylsiloxy Phenyl Trimethicone, Ethylhexyl Palmitate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Butylene Glycol, Trimethylsiloxysilicate, Polyhydroxystearic Acid, Prunus Amygdalus Amara (Bitter Almond) Kernel Oil, Camellia Sinensis Leaf Extract, Pyrus Malus (Apple) Leaf Extract, Hippophae Rhamnoides Oil, Jasminum Officinale (Jasmine) Flower Water, Vanilla Planifolia Fruit Extract, Saccharomyces/Hippophae Rhamnoides Fruit Ferment Filtrate, Hippophae Rhamnoides Fruit Oil, Glycine Max (Soybean) Seed Extract, Persea Gratissima (Avocado) Oil, Sodium Hyaluronate, Calendula Officinalis Flower Extract, Oenothera Biennis (Evening Primrose) Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Polyglyceryl-2 Dipolyhydroxystearate, Disteardimonium Hectorite, Magnesium Sulfate, Aluminum Hydroxide, Polymethylsilsesquioxane, Hydrogen Dimethicone, Stearic Acid, PVP, Caprylyl Glycol, Glyceryl Caprylate, Caprylic/Capric Triglyceride, Ceramide NP, Panthenol, Beta-Glucan, Tocopherol, 1,2-Hexanediol, Sodium PCA, Ethylhexylglycerin

* Please review the disclaimer below.