NDC 68745-2136 Vitalumiere Aqua Ultra-light Skin Perfecting Sunscreen Makeup Broad Spectrum Spf 15, 42 Beige Rose

Titanium Dioxide

NDC Product Code 68745-2136

NDC CODE: 68745-2136

Proprietary Name: Vitalumiere Aqua Ultra-light Skin Perfecting Sunscreen Makeup Broad Spectrum Spf 15, 42 Beige Rose 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 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

NDC 68745-2136-1

Package Description: 1 BOTTLE, PUMP in 1 CARTON > 30 mL in 1 BOTTLE, PUMP

NDC 68745-2136-2

Package Description: 1 BOTTLE in 1 CARTON > 20 mL in 1 BOTTLE

NDC Product Information

Vitalumiere Aqua Ultra-light Skin Perfecting Sunscreen Makeup Broad Spectrum Spf 15, 42 Beige Rose with NDC 68745-2136 is a a human over the counter drug product labeled by Chanel Parfums Beaute. The generic name of Vitalumiere Aqua Ultra-light Skin Perfecting Sunscreen Makeup Broad Spectrum Spf 15, 42 Beige Rose is titanium dioxide. The product's dosage form is emulsion and is administered via topical form.

Labeler Name: Chanel Parfums Beaute

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.

Vitalumiere Aqua Ultra-light Skin Perfecting Sunscreen Makeup Broad Spectrum Spf 15, 42 Beige Rose 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 64 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)
  • METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ALCOHOL (UNII: 3K9958V90M)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
  • ISODODECANE (UNII: A8289P68Y2)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • TALC (UNII: 7SEV7J4R1U)
  • DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
  • NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • LAUROYL LYSINE (UNII: 113171Q70B)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • LAMINARIA DIGITATA (UNII: 15E7C67EE8)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ULTRAMARINE BLUE (UNII: I39WR998BI)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • MICA (UNII: V8A1AW0880)
  • WATER (UNII: 059QF0KO0R)
  • METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ALCOHOL (UNII: 3K9958V90M)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
  • ISODODECANE (UNII: A8289P68Y2)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • TALC (UNII: 7SEV7J4R1U)
  • DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
  • NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • LAUROYL LYSINE (UNII: 113171Q70B)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • LAMINARIA DIGITATA (UNII: 15E7C67EE8)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ULTRAMARINE BLUE (UNII: I39WR998BI)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • MICA (UNII: V8A1AW0880)
  • WATER (UNII: 059QF0KO0R)
  • METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ALCOHOL (UNII: 3K9958V90M)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
  • ISODODECANE (UNII: A8289P68Y2)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • TALC (UNII: 7SEV7J4R1U)
  • DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
  • NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • LAUROYL LYSINE (UNII: 113171Q70B)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • LAMINARIA DIGITATA (UNII: 15E7C67EE8)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ULTRAMARINE BLUE (UNII: I39WR998BI)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • MICA (UNII: V8A1AW0880)
  • WATER (UNII: 059QF0KO0R)
  • METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ALCOHOL (UNII: 3K9958V90M)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
  • ISODODECANE (UNII: A8289P68Y2)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • TALC (UNII: 7SEV7J4R1U)
  • DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
  • NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • LAUROYL LYSINE (UNII: 113171Q70B)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • LAMINARIA DIGITATA (UNII: 15E7C67EE8)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ULTRAMARINE BLUE (UNII: I39WR998BI)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • MICA (UNII: V8A1AW0880)

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: Chanel Parfums Beaute
Labeler Code: 68745
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: 05-22-2021 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: 12-31-2022 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.

Vitalumiere Aqua Ultra-light Skin Perfecting Sunscreen Makeup Broad Spectrum Spf 15, 42 Beige Rose 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

Other

Drug Facts

Active Ingredient

Titanium dioxide 6.4%

Purpose

Sunscreen

Uses

  • Helps prevent sunburnif used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if skin rash occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • For sunscreen use:apply liberally 15 minutes before sun exposureuse a water resistant sunscreen if swimming or sweatingreapply at least every 2 hoursSun 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 value 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-sleeved shirts, pants, hats, and sunglassesChildren 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 • methyl trimethicone • dimethicone • alcohol • silica • triethylhexanoin • butylene glycol • synthetic fluorphlogopite • isododecane • ricinus communis (castor) seed oil • acrylates/polytrimethylsiloxymethacrylate copolymer • talc • dimethicone/PEG-10/15 crosspolymer • nelumbo nucifera root water • PEG-10 dimethicone • stearic acid • alumina • potassium sorbate • fragrance • magnesium sulfate • caprylyl glycol • lauroyl lysine • triethoxycaprylylsilane • sodium hyaluronate • aluminum hydroxide • dipropylene glycol • tocopheryl acetate • pentylene glycol • laminaria digitata extract • tocopherol (may contain) ultramarines • iron oxides • titanium dioxide • mica IL57a-i

* Please review the disclaimer below.