NDC 67015-2035 Haute Protection High Protection Tinted Compact Broad Spectrum Spf 50 Honey

Titanium Dioxide, Zinc Oxide

NDC Product Code 67015-2035

NDC Code: 67015-2035

Proprietary Name: Haute Protection High Protection Tinted Compact Broad Spectrum Spf 50 Honey 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

  • 67015 - Pierre Fabre Usa Inc.
    • 67015-2035 - Haute Protection High Protection Tinted Compact Broad Spectrum Spf 50 Honey

NDC 67015-2035-1

Package Description: 1 CONTAINER in 1 CARTON > 10 g in 1 CONTAINER (67015-2035-0)

NDC Product Information

Haute Protection High Protection Tinted Compact Broad Spectrum Spf 50 Honey with NDC 67015-2035 is a a human over the counter drug product labeled by Pierre Fabre Usa Inc.. The generic name of Haute Protection High Protection Tinted Compact Broad Spectrum Spf 50 Honey is titanium dioxide, zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Pierre Fabre Usa 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.

Haute Protection High Protection Tinted Compact Broad Spectrum Spf 50 Honey 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 4.9 g/100g
  • TITANIUM DIOXIDE 13.7 g/100g

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)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K)
  • HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • TRIBEHENIN (UNII: 8OC9U7TQZ0)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
  • SQUALANE (UNII: GW89575KF9)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • TALC (UNII: 7SEV7J4R1U)
  • ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
  • ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

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: Pierre Fabre Usa Inc.
Labeler Code: 67015
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: 06-03-2019 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.

Haute Protection High Protection Tinted Compact Broad Spectrum Spf 50 Honey Product Label Images

Haute Protection High Protection Tinted Compact Broad Spectrum Spf 50 Honey 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 13.7 %

ZINC OXIDE 4.9 %

Purpose

Sunscreen

Uses

  • Tinted compact SPF 50 helps prevent sunburn.If used as directed with other sun protection measures ( see
  • Directions for use), decreases the risk if skin cancer and early skin aging caused by the sun.

Warnings

For external use onlyDo not use on damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove.
Stop use and consult a health care practitioner if rash occurs.

Keep Out Of Reach Of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions For Use

  • Apply liberally/generously and evenly15 minutes before sun exposure.Reapply:after 40 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hours.Children under 6 months: Consult a health care practitioner.Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other skin protection measures including:
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.wear long-sleeve shirts, pants, hats and sunglasses.

Inactive Ingredients

DIMETHICONE, HYDROGENATED POLYISOBUTENE, PHENYL TRIMETHICONE, ISODECYL NEOPENTANOATE, SQUALANE, TALC, ETHYLHEXYL HYDROXYSTEARATE, POLYETHYLENE, POLYMETHYL METHACRYLATE, SILICA, WATER/EAU, POLYGLYCERLYL-3 DIISOSTEARATE, ALUMINA, STEARIC ACID, BEESWAX, BHT, CAPRYLIC/CAPRIC TRIGLYCERIDE, MICROCRYSTALLINE WAX, PHENOXYETHANOL, TOCOPHEROL, TOCOPHERYL GLUCOSIDE, TRIBEHENIN, TRIETHOXYCAPRYLYLSILANE, TITANIUM DIOXIDE (CI77891), IRON OXIDES (CI77491), (CI77492), (CI77499)

Other Information

Protect this product from excessive heat and direct sun.

Haute Protection High Protection Tinted Compact Broad Spectrum Spf 50 Beige 10G (67015-2035-0)

HAUTEPROTECTIONHIGH PROTECTIONFragrance-freeSPF 50 UVB UVA Broad spectrumWater-resistant40 minutesHoneyTinted compactFor intolerant skinPARIS10g e/NET WT. 0.3 OZ.- NPN 80085664

* Please review the disclaimer below.

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