NDC 72805-021 Mychelle Dermaceuticals Replenishing Solar Defense Body Spf 50 Protect

Zinc Oxide

  1. Labeler Index
  2. French Transit, Ltd.
  3. NDC: 72805-021 Mychelle Dermaceuticals Replenishing Solar Defense Body Spf 50 Protect

NDC Product Code 72805-021

NDC CODE: 72805-021

Proprietary Name: Mychelle Dermaceuticals Replenishing Solar Defense Body Spf 50 Protect 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: Zinc Oxide 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
  • This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.

NDC Code Structure

  • 72805 - French Transit, Ltd.
    • 72805-021 - Mychelle Dermaceuticals Replenishing Solar Defense Body Spf 50

NDC 72805-021-68

Package Description: 177 mL in 1 TUBE

NDC Product Information

Mychelle Dermaceuticals Replenishing Solar Defense Body Spf 50 Protect with NDC 72805-021 is a a human over the counter drug product labeled by French Transit, Ltd.. The generic name of Mychelle Dermaceuticals Replenishing Solar Defense Body Spf 50 Protect is zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: French Transit, Ltd.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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 Replenishing Solar Defense Body Spf 50 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 21 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)
  • ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
  • ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • KARUM SEED OIL (UNII: 62160PU6FJ)
  • SODIUM GLUCONATE (UNII: R6Q3791S76)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)
  • VANILLIN (UNII: CHI530446X)

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 Replenishing Solar Defense Body Spf 50 Protect Product Label Images

Mychelle Dermaceuticals Replenishing Solar Defense Body Spf 50 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 21%

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.Apply liberally and evenly 15 minutes before sun exposure.Reapply: After 80 minutes of swimming or sweating.Immediately after towel dryingAt least every 2 hoursSun 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

Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea Butter), Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/ Sebacic Acid Copolymer, Caprylyl Glycol , Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Glycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyhydroxystearic Acid, Pongamia Glabra Seed Oil, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Undaria Pinnatifida Extract, Vanillin, Water

Other Information

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

* Please review the disclaimer below.