NDC 51346-523 Provence Air Skin Fit One Day Lasting Foundation N45 Tan Brown

Octinoxate, Zinc Oxide, Titanium Dioxide

NDC Product Code 51346-523

NDC Code: 51346-523

Proprietary Name: Provence Air Skin Fit One Day Lasting Foundation N45 Tan Brown 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: Octinoxate, Zinc Oxide, Titanium Dioxide 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

  • 51346 - Nature Republic Co., Ltd.
    • 51346-523 - Provence Air Skin Fit One Day Lasting Foundation N45 Tan Brown

NDC 51346-523-02

Package Description: 1 CONTAINER in 1 CARTON > 30 mL in 1 CONTAINER (51346-523-01)

NDC Product Information

Provence Air Skin Fit One Day Lasting Foundation N45 Tan Brown with NDC 51346-523 is a a human over the counter drug product labeled by Nature Republic Co., Ltd.. The generic name of Provence Air Skin Fit One Day Lasting Foundation N45 Tan Brown is octinoxate, zinc oxide, titanium dioxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Nature Republic Co., Ltd.

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.

Provence Air Skin Fit One Day Lasting Foundation N45 Tan Brown 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.

  • OCTINOXATE 1.5 g/30mL
  • ZINC OXIDE 1.47 g/30mL
  • TITANIUM DIOXIDE 1.03 g/30mL

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)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)

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: Nature Republic Co., Ltd.
Labeler Code: 51346
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: 06-01-2019 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.

Provence Air Skin Fit One Day Lasting Foundation N45 Tan Brown Product Label Images

Provence Air Skin Fit One Day Lasting Foundation N45 Tan Brown 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

Active Ingredient: ETHYLHEXYL METHOXYCINNAMATE 5%, ZINC OXIDE 4.9%, TITANIUM DIOXIDE 3.46%

Inactive Ingredient

Inactive ingredients: WATER, CYCLOPENTASILOXANE, PHENYL TRIMETHICONE, ETHYLHEXYL PALMITATE, IRON OXIDES (CI 77492), BUTYLENE GLYCOL, ISODODECANE, POLYGLYCERYL-2 DIISOSTEARATE, ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATECOPOLYMER, PENTYLENE GLYCOL, IRON OXIDES (CI 77491), IRON OXIDES (CI 77499), GLYCERIN, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, MAGNESIUM STEARATE, PHENOXYETHANOL, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, PEG-30 DIPOLYHYDROXYSTEARATE, SYNTHETIC FLUORPHLOGOPITE, BIS-PEG/PPG-14/14 DIMETHICONE, BEESWAX, TRIETHOXYCAPRYLYLSILANE, ALUMINUM HYDROXIDE, STEARIC ACID, PROPYLENE CARBONATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DIMETHICONE, ETHYLHEXYLGLYCERIN, FRAGRANCE(PARFUM), DISODIUM EDTA, 1,2-HEXANEDIOL, HIBISCUS SABDARIFFA FLOWER EXTRACT, ROSA CANINA FRUIT EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT, LIPPIA CITRIODORA LEAF EXTRACT, MELISSA OFFICINALIS EXTRACT, MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT, ROSA DAMASCENA FLOWER EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, SALVIA OFFICINALIS (SAGE) LEAF EXTRACT, THYMUS VULGARIS (THYME) LEAF EXTRACT, TILIA EUROPAEA FLOWER EXTRACT

Purpose

Purpose: Sunscreen

Warnings

WARNINGS:For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children. Replace the cap after use.

Description

Uses: The long-lasting foundation provides 24-hour closely adhering cover.Directions: Fully shake the container before use. Gently apply an appropriate amount on the face in the direction of skin texture with your hand or the applicator. Lightly pat as a finishing touch.

* Please review the disclaimer below.

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