NDC 51386-702 Napoleon Perdis Advanced Mineral Makeup Broad Spectrum Spf 15 Look 2

Titanium Dioxide, Zinc Oxide

NDC Product Code 51386-702

NDC CODE: 51386-702

Proprietary Name: Napoleon Perdis Advanced Mineral Makeup Broad Spectrum Spf 15 Look 2 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, 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

  • 51386 - Napoleon Perdis Cosmetics, Inc
    • 51386-702 - Napoleon Perdis Advanced Mineral Makeup Broad Spectrum Spf 15 Look 2

NDC 51386-702-00

Package Description: 1 TUBE in 1 CARTON > 30 mL in 1 TUBE

NDC Product Information

Napoleon Perdis Advanced Mineral Makeup Broad Spectrum Spf 15 Look 2 with NDC 51386-702 is a a human over the counter drug product labeled by Napoleon Perdis Cosmetics, Inc. The generic name of Napoleon Perdis Advanced Mineral Makeup Broad Spectrum Spf 15 Look 2 is titanium dioxide, zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Napoleon Perdis Cosmetics, Inc

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.

Napoleon Perdis Advanced Mineral Makeup Broad Spectrum Spf 15 Look 2 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 60 mg/mL
  • ZINC OXIDE 30 mg/mL

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)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
  • HEXAMETHYLENE DIISOCYANATE (UNII: 0I70A3I1UF)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • SQUALANE (UNII: GW89575KF9)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • PHYTANTRIOL (UNII: 8LVI07A72W)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
  • OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
  • ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
  • ASIAN GINSENG (UNII: CUQ3A77YXI)
  • PURSLANE (UNII: M6S840WXG5)
  • CENTELLA ASIATICA (UNII: 7M867G6T1U)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • .GAMMA.-AMINOBUTYRIC ACID (UNII: 2ACZ6IPC6I)
  • BARIUM SULFATE (UNII: 25BB7EKE2E)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • ZINC CHLORIDE (UNII: 86Q357L16B)
  • LYSINE (UNII: K3Z4F929H6)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • MICA (UNII: V8A1AW0880)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)

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: Napoleon Perdis Cosmetics, Inc
Labeler Code: 51386
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: 12-12-2013 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.

Napoleon Perdis Advanced Mineral Makeup Broad Spectrum Spf 15 Look 2 Product Label Images

Napoleon Perdis Advanced Mineral Makeup Broad Spectrum Spf 15 Look 2 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 Ingredients

Titanium Dioxide 6.0%


Zinc Oxide 3.0%

Purpose

Sunscreen

Uses

Helps prevent sunburn. Higher SPF gives more sunburn protection.

Warnings

For external use only.

When Using This Product:

Keep out of eyes. Rinse with water to remove.

Stop Use And See A Doctor If

Rash or irritation develops and lasts.

Directions

Apply evenly before sun exposure. Children under 6 months of age: ask a doctor. Reapply as needed or after towel drying, swimming or sweating.

Other Information

Moderate sun protection product. Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive Ingredients:

WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, POLYGLYCERYL-4 ISOSTEARATE, CETYL PEG/PPG-10/1 DIMETHICONE, STEARIC ACID, ALUMINUM HYDROXIDE, HEXYL LAURATE, DIMETHICONE CROSSPOLYMER, SQUALANE, PROPYLENE CARBONATE, PHYTANTRIOL, RETINYL PALMITATE, TOCOPHERYL ACETATE, TOCOPHEROL, TETRAHEXYLDECYL ASCORBATE, OLEANOLIC ACID, ENANTIA CHLORANTHA BARK EXTRACT, PANAX GINSENG ROOT EXTRACT, PORTULACA OLERACEA EXTRACT, CENTELLA ASIATICA EXTRACT, SODIUM HYALURONATE, POLYDODECANAMIDEAMINIUM TRIAZADIPHENYLETHENE SULFONATE, POLYVINYLALCOHOL CROSSPOLYMER, POLYSILICONE-11, PENTAERYTHRITYL TETRAISOSTEARATE, SILICA DIMETHYL SILYLATE, SODIUM CHONDROITIN SULFATE, ATELOCOLLAGEN, AMINOBUTYRIC ACID, BARIUM SULFATE, SODIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, ZINC CHLORIDE, LYSINE, DISODIUM EDTA, SODIUM DEHYDROACETATE, TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, CAPRYLYL GLYCOL, HEXYLENE GLYCOL, SODIUM BENZOATE, MAY CONTAIN: MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499).

* Please review the disclaimer below.