NDC 72805-091 Mychelle Dermaceuticals Sun Shield Spf 50 Light/medium Protect

Zinc Oxide

NDC Product Code 72805-091

NDC 72805-091-31

Package Description: 1 BOTTLE, DROPPER in 1 BOX > 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Mychelle Dermaceuticals Sun Shield Spf 50 Light/medium Protect with NDC 72805-091 is a a human over the counter drug product labeled by French Transit, Ltd.. The generic name of Mychelle Dermaceuticals Sun Shield Spf 50 Light/medium Protect is zinc oxide. The product's dosage form is liquid and is administered via topical form.

Labeler Name: French Transit, Ltd.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Mychelle Dermaceuticals Sun Shield Spf 50 Light/medium Protect 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.

  • ZINC OXIDE 16.1 g/100mL

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)
  • AGAVE TEQUILANA LEAF (UNII: 05545M0E3M)
  • BENTONITE (UNII: A3N5ZCN45C)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
  • MALTOSE, UNSPECIFIED FORM (UNII: XJ6S9RV06F)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • SODIUM GLUCONATE (UNII: R6Q3791S76)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • TRIHYDROXYSTEARIN (UNII: 06YD7896S3)

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: French Transit, Ltd.
Labeler Code: 72805
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: 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.

Mychelle Dermaceuticals Sun Shield Spf 50 Light/medium Protect Product Label Images

Mychelle Dermaceuticals Sun Shield Spf 50 Light/medium Protect 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

Other

DRUG FACTS

Active Ingredient

Zinc Oxide 16.1%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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 and irritation develops and lasts.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • SHAKE WELL BEFORE USE.For daily use, apply to clean, dry skin and allow to absorb completely before applying makeup.Apply liberally and evenly 15 minutes before sun exposure.Use a water resistant sunscreen if swimming or sweating.Reapply at least every 2 hours.Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. – 2 p.m.Wear long-sleeve shirts, pants, hats and sunglasses.Children under 6 months: Ask a doctor.

Inactive Ingredients

Agave Tequilana Leaf Extract, Bentonite, Butyloctyl Salicylate, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Coco-Glucoside, Diheptyl Succinate, Glycerin, Hydrolyzed Wheat Protein / PVP Crosspolymer, Iron Oxides, Jojoba Esters, Maltose, Octyldodecanol, Sodium Gluconate, Tocopherol, Trihydroxystearin, Water

Other Information

  • Protect this product from excessive heat and direct sun.May stain some fabrics.

* Please review the disclaimer below.