NDC 51346-520 Provence Intensive Ampoule Bb 02 Natural Beige

Titanium Dioxide, Octinoxate, Zinc Oxide

NDC Product Code 51346-520

NDC CODE: 51346-520

Proprietary Name: Provence Intensive Ampoule Bb 02 Natural Beige 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: Titanium Dioxide, Octinoxate, 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.

NDC Code Structure

  • 51346 - Nature Republic Co., Ltd.
    • 51346-520 - Provence Intensive Ampoule Bb 02 Natural Beige

NDC 51346-520-02

Package Description: 1 CONTAINER in 1 CARTON > 50 mL in 1 CONTAINER (51346-520-01)

NDC Product Information

Provence Intensive Ampoule Bb 02 Natural Beige with NDC 51346-520 is a a human over the counter drug product labeled by Nature Republic Co., Ltd.. The generic name of Provence Intensive Ampoule Bb 02 Natural Beige is titanium dioxide, octinoxate, zinc oxide. 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 Intensive Ampoule Bb 02 Natural Beige 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.

  • TITANIUM DIOXIDE 3.95 g/50mL
  • OCTINOXATE 1.5 g/50mL
  • ZINC OXIDE .95 g/50mL

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)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: 12-20-2016 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 - 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.

Provence Intensive Ampoule Bb 02 Natural Beige Product Label Images

Provence Intensive Ampoule Bb 02 Natural Beige 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: TITANIUM DIOXIDE 7.9%, ETHYLHEXYL METHOXYCINNAMATE 3.0%, ZINC OXIDE 1.9%

Inactive Ingredient

INACTIVE INGREDIENTS:WATER, CYCLOPENTASILOXANE, TALC, GLYCERIN, PEG-10 DIMETHICONE, NIACINAMIDE, DIPROPYLENE GLYCOL, ISOEICOSANE, CAPRYLYL METHICONE, TRIDECYL TRIMELLITATE, CYCLOMETHICONE, IRON OXIDES(CI 77492), DISTEARDIMONIUM HECTORITE, TRIETHYLHEXANOIN, HEXYL LAURATE, MAGNESIUM SULFATE, C12-14 PARETH-3, PHENOXYETHANOL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ACRYLATES/DIMETHICONE COPOLYMER, IRON OXIDES(CI 77491), METHICONE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, SILICA, PALMITIC ACID, IRON OXIDES(CI 77499), ETHYLHEXYLGLYCERIN, TOCOPHERYL ACETATE, FRAGRANCE, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, DIMETHICONE, ADENOSINE, SODIUM HYALURONATE, ALCOHOL, HYDROLYZED HYALURONIC ACID, PANAX GINSENG ROOT EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER WATER, BUTYLENE GLYCOL, ROYAL JELLY, FICUS CARICA (FIG) FRUIT EXTRACT, MALPIGHIA EMARGINATA (ACEROLA) FRUIT EXTRACT, SALMON EGG EXTRACT, CARICA PAPAYA (PAPAYA) FRUIT, CORNUS OFFICINALIS FRUIT EXTRACT, LIPPIA CITRIODORA LEAF EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, SODIUM BENZOATE, CITRIC ACID, SILK AMINO ACIDS, PROPOLIS EXTRACT, OENOTHERA BIENNIS (EVENING PRIMROSE) OIL, SQUALANE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL

Purpose

Purpose: Sunscreen

Warnings

WARNINGS:1. For external use only.2. Avoid contact with eyes and mouth.3. Discontinue use if signs of irritation or rashes appear.4. Keep out of reach of children.5. Replace the cap after use.

Description

Indications & usage: The BB cream provides natural coverage with UV protection.Dosage & administration: Apply an appropriate amount to the entire face.

* Please review the disclaimer below.