NDC 76230-727 Everyday Facial Moisturizer And Sunscreen Spf 20

Zinc Oxide

NDC Product Code 76230-727

NDC 76230-727-09

Package Description: 1 BOTTLE in 1 PACKAGE > 75 mL in 1 BOTTLE

NDC Product Information

Everyday Facial Moisturizer And Sunscreen Spf 20 with NDC 76230-727 is a a human over the counter drug product labeled by 714 Essentials Ltd. The generic name of Everyday Facial Moisturizer And Sunscreen Spf 20 is zinc oxide. The product's dosage form is cream and is administered via topical form.

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.

Everyday Facial Moisturizer And Sunscreen Spf 20 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)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CHLORPHENESIN (UNII: I670DAL4SZ)

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: 714 Essentials Ltd
Labeler Code: 76230
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: 06-09-2011 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.

Everyday Facial Moisturizer And Sunscreen Spf 20 Product Label Images

Everyday Facial Moisturizer And Sunscreen Spf 20 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

ACTIVE INGREDIENT: Zinc Oxide 16.32%

Purpose

Sunscreen

Indications & Usage

USE: Provides broad spectrum protection against UVA (cause of cancer and aging) and UVB (sunburn) rays. Recommended for all skin types. Its powerful anti-inflammatory and antioxident properties (green tea, algae, and Vitamin E) guard against free radical damage. No ghostly residue. PABA free. Oil free.

Warning:

For external us only. Do not get into eyes.

Dosage & Administration

DIRECTIONS: Apply daily before sun exposure Re-apply after swimming.

Other Ingredients:

Water, Cyclopentasiloxane, PEG-10 Dimethicone, Dimethicone, Butylene Glycol, Caprylyl Methicone, Isononyl Isononanoate, Dipropylene Glycol, Sodium Chloride, Hydrogenated Polyisobutene, Disteardimonium Hectorite, Dimethiconol, Sodium Hyaluronate, Sodium PCA, Algae Extract, Camellia Sinensis Leaf Extract, Dipotassium Glycyrrhizate, Panthenol, Tocopheryl Acetate, Methicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Fragrance.

* Please review the disclaimer below.