NDC 60905-0042 Givenchy Blurring Foundation Balm Bare Skin Perfector - Broad Spectrum Spf 15 Nude Sand

Octinoxate, Titanium Dioxide

NDC Product Code 60905-0042

NDC CODE: 60905-0042

Proprietary Name: Givenchy Blurring Foundation Balm Bare Skin Perfector - Broad Spectrum Spf 15 Nude Sand 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, 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

  • 60905 - Lvmh Fragrance Brands
    • 60905-0042 - Givenchy Blurring Foundation Balm Bare Skin Perfector - Broad Spectrum Spf 15 Nude Sand

NDC 60905-0042-1

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

NDC 60905-0042-2

Package Description: 10 mL in 1 TUBE

NDC Product Information

Givenchy Blurring Foundation Balm Bare Skin Perfector - Broad Spectrum Spf 15 Nude Sand with NDC 60905-0042 is a a human over the counter drug product labeled by Lvmh Fragrance Brands. The generic name of Givenchy Blurring Foundation Balm Bare Skin Perfector - Broad Spectrum Spf 15 Nude Sand is octinoxate, titanium dioxide. The product's dosage form is emulsion and is administered via topical form.

Labeler Name: Lvmh Fragrance Brands

Dosage Form: Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)

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.

Givenchy Blurring Foundation Balm Bare Skin Perfector - Broad Spectrum Spf 15 Nude Sand 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 39.96 mg/mL
  • TITANIUM DIOXIDE 21.9 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)
  • PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • ALCOHOL (UNII: 3K9958V90M)
  • SACCHARIDE ISOMERATE (UNII: W8K377W98I)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • TROMETHAMINE (UNII: 023C2WHX2V)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
  • DIAMOND (UNII: 6GRV67N0U2)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • GERANIOL (UNII: L837108USY)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)

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: Lvmh Fragrance Brands
Labeler Code: 60905
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: 03-25-2015 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.

Givenchy Blurring Foundation Balm Bare Skin Perfector - Broad Spectrum Spf 15 Nude Sand Product Label Images

Givenchy Blurring Foundation Balm Bare Skin Perfector - Broad Spectrum Spf 15 Nude Sand 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

Octinoxate 3.996%Titanium Dioxide 2.19%

Purpose

Sunscreen

Use

■ Helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin


cancer and early skin aging caused by the sun.

Do Not Use

On damaged or broken skin.

When Using This Product

Keep out of eyes.  Rinse with water to remove.

Stop Use And Ask A Doctor

If rash occurs.

Keep Out Of Reach Of Children.

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

Directions

■ Apply liberally 15 minutes before sun exposure.


■ Reapply at least every 2 hours.


■ Use a water resistant sunscreen if swimming or sweating.


■ 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 sun protection measures including:


    ■ limit time in the sun, especially from 10 a.m. – 2 p.m.


    ■ wear long-sleeve shirts, pants, hats, and sunglasses


■ Children under 6 months of age: ask a doctor.

Other Information

■ Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Water, Cyclopentasiloxane, Butylene Glycol, PEG-9 Polydimethylsiloxyethyl Dimethicone, Phenyl Trimethicone, Alcohol, Saccharide Isomerate, Polymethylsilsesquioxane, Acrylates/Dimethicone Copolymer, Phenoxyethanol, Sorbitan Sesquioleate, Aluminum Hydroxide, Dimethicone, Sodium Myristoyl Glutamate, Stearic Acid, Disteardimonium Hectorite, Tocopheryl Acetate, Pentylene Glycol, Jasminum Officinale (Jasmine) Flower Extract, Fragrance, Propylene Carbonate, Tromethamine, Citric Acid, Sodium Citrate, Butylphenyl Methylpropional, Diamond Powder,


BHT, Geraniol, Tocopherol, Titanium Dioxide, Iron Oxides.

* Please review the disclaimer below.