NDC 73330-0001 Plushmallow Sunstick

Octocrylene, Homosalate, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane

NDC Product Code 73330-0001

NDC Code: 73330-0001

Proprietary Name: Plushmallow Sunstick 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: Octocrylene, Homosalate, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane 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

  • 73330 - Cosnine Inc

NDC 73330-0001-1

Package Description: 19 g in 1 PACKAGE

NDC Product Information

Plushmallow Sunstick with NDC 73330-0001 is a a human over the counter drug product labeled by Cosnine Inc. The generic name of Plushmallow Sunstick is octocrylene, homosalate, ethylhexyl salicylate, butyl methoxydibenzoylmethane. The product's dosage form is stick and is administered via topical form.

Labeler Name: Cosnine Inc

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

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.

Plushmallow Sunstick 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.

  • OCTOCRYLENE 9.5 g/100g
  • AVOBENZONE 3 g/100g
  • HOMOSALATE 9.5 g/100g
  • OCTISALATE 4.5 g/100g

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.

  • DIMETHICONE (UNII: 92RU3N3Y1O)

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: Cosnine Inc
Labeler Code: 73330
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 08-31-2019 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: 12-31-2020 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.

Plushmallow Sunstick Product Label Images

Plushmallow Sunstick 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

Octocrylene, Homosalate, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane

Inactive Ingredient

Dimethicone

Polyethylene

Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

Ozokerite

Acrylates Copolymer

Silica

Neopentyl Glycol Diheptanoate

Butyloctyl Salicylate

Cetyl Ethylhexanoate

HDI/Trimethylol Hexyllactone Crosspolymer

Polymethyl Methacrylate

Cetyl Alcohol

Tocopheryl Acetate

Caprylic/Capric Triglyceride

Citrus Aurantium Dulcis (Orange) Peel Oil

Geranium Maculatum Oil

Lavandula Angustifolia (Lavender) Oil

Citrus Aurantium Bergamia (Bergamot) Fruit Oil

Cymbopogon Martini Oil

Anthemis Nobilis Flower Oil

Otc - Purpose

Protects the skin from harmful UV rays (SPF50+ PA++++)

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Evenly apply a moderate amount

on areas exposed to sunlight during the last step of

your skincare routine. Carry it with you at all times

to frequently apply to necessary areas (face, body).

Warnings

1. While using this product , if there

is any abnormal symptoms or side effect such as red spot,

swelling or itching, please consult with dermatologist.

2. Do not use in areas with wounds 3. Instructions for sto

-rage and usage. (i) Keep out of reach of infants and chil

-dren (ii) Store it in a place away from direct sunlight

Dosage & Administration

For external use only

* Please review the disclaimer below.