NDC 51346-465 Provence Air Skin Fit Oi L Control Bb Cushion 01 Light Beige

Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate

NDC Product Code 51346-465

NDC CODE: 51346-465

Proprietary Name: Provence Air Skin Fit Oi L Control Bb Cushion 01 Light 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: Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate 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

  • 51346 - Nature Republic Co., Ltd.
    • 51346-465 - Provence Air Skin Fit Oi L Control Bb Cushion 01 Light Beige

NDC 51346-465-02

Package Description: 1 CONTAINER in 1 CARTON > 13 g in 1 CONTAINER (51346-465-01)

NDC Product Information

Provence Air Skin Fit Oi L Control Bb Cushion 01 Light Beige with NDC 51346-465 is a a human over the counter drug product labeled by Nature Republic Co., Ltd.. The generic name of Provence Air Skin Fit Oi L Control Bb Cushion 01 Light Beige is zinc oxide, titanium dioxide, octinoxate, octisalate. The product's dosage form is powder and is administered via topical form.

Labeler Name: Nature Republic Co., Ltd.

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

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 Oi L Control Bb Cushion 01 Light 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.

  • ZINC OXIDE 1.24 g/13g
  • TITANIUM DIOXIDE 1.24 g/13g
  • OCTINOXATE .91 g/13g
  • OCTISALATE .58 g/13g

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: 04-01-2017 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.

Provence Air Skin Fit Oi L Control Bb Cushion 01 Light Beige Product Label Images

Provence Air Skin Fit Oi L Control Bb Cushion 01 Light 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 ingredients: ZINC OXIDE 9.60%, TITANIUM DIOXIDE 9.58%, ETHYLHEXYL METHOXYCINNAMATE 7.00%, ETHYLHEXYL SALICYLATE 4.50%

Inactive Ingredient

Inactive ingredients: WATER, CYCLOPENTASILOXANE, CAPRYLYL METHICONE, GLYCERIN, ISODODECANE, PHENYL TRIMETHICONE, DIPROPYLENE GLYCOL, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, NIACINAMIDE, COCO-CAPRYLATE/CAPRATE, TALC, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, SORBITAN SESQUIOLEATE, CAMELLIA SINENSIS LEAF EXTRACT, ALOE BARBADENSIS LEAF JUICE, CHRYSANTHEMUM MORIFOLIUM FLOWER EXTRACT, NELUMBO NUCIFERA FLOWER EXTRACT, ALTHAEA OFFICINALIS LEAF/ROOT EXTRACT, OCIMUM BASILICUM (BASIL) FLOWER/LEAF EXTRACT, HOUTTUYNIA CORDATA EXTRACT, ANTHEMIS NOBILIS FLOWER EXTRACT, FOENICULUM VULGARE (FENNEL) LEAF EXTRACT, CENTELLA ASIATICA EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT, SYRINGA VULGARIS (LILAC) EXTRACT, LILIUM CANDIDUM FLOWER EXTRACT, ROSA HYBRID FLOWER EXTRACT, MAGNESIUM SULFATE, ALUMINUM HYDROXIDE, PEG-10 DIMETHICONE, STEARIC ACID, DISTEARDIMONIUM HECTORITE, TRIETHOXYCAPRYLYLSILANE, PALMITIC ACID, SILICA, ETHYLHEXYLGLYCERIN, TOCOPHERYL ACETATE, DIMETHICONE, AMINOPROPYL DIMETHICONE, POLYMETHYLSILSESQUIOXANE, ADENOSINE, ALUMINA, BHT, FRAGRANCE, PHENOXYETHANOL, IRON OXIDES(CI 77492), IRON OXIDES(CI 77491), IRON OXIDES(CI 77499)

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

Indications & Usage: - The oil control cushion helps remove excessive sebum, and provides high coverage.Dosage & Administration: - Take an adequate amount by gently pressing the sponge with the puff, and apply gently to the face.

* Please review the disclaimer below.