NDC 49967-040 Vichy Laboratories Capital Soleil Uva Uvb 60 Titanium Dioxide 100% Mineral 15 Mineral Rich Water Ultra Lightweight

Titanium Dioxide

NDC Product Code 49967-040

NDC CODE: 49967-040

Proprietary Name: Vichy Laboratories Capital Soleil Uva Uvb 60 Titanium Dioxide 100% Mineral 15 Mineral Rich Water Ultra Lightweight 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

  • 49967 - L'oreal Usa Products Inc
    • 49967-040 - Vichy Laboratories Capital Soleil Uva Uvb 60 Titanium Dioxide 100% Mineral 15 Mineral Rich Water Ultra Lightweight

NDC 49967-040-01

Package Description: 1 BOTTLE in 1 CARTON > 45 mL in 1 BOTTLE

NDC Product Information

Vichy Laboratories Capital Soleil Uva Uvb 60 Titanium Dioxide 100% Mineral 15 Mineral Rich Water Ultra Lightweight with NDC 49967-040 is a a human over the counter drug product labeled by L'oreal Usa Products Inc. The generic name of Vichy Laboratories Capital Soleil Uva Uvb 60 Titanium Dioxide 100% Mineral 15 Mineral Rich Water Ultra Lightweight is titanium dioxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: L'oreal Usa Products Inc

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Vichy Laboratories Capital Soleil Uva Uvb 60 Titanium Dioxide 100% Mineral 15 Mineral Rich Water Ultra Lightweight 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 148 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)
  • ISODODECANE (UNII: A8289P68Y2)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • UNDECANE (UNII: JV0QT00NUE)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • NYLON-12 (UNII: 446U8J075B)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • PHENETHYL BENZOATE (UNII: 0C143929GK)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • TRIDECANE (UNII: A3LZF0L939)
  • DICAPRYLYL ETHER (UNII: 77JZM5516Z)
  • TALC (UNII: 7SEV7J4R1U)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • ALUMINUM STEARATE (UNII: U6XF9NP8HM)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • BENZYL BENZOATE (UNII: N863NB338G)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • PEG-8 LAURATE (UNII: 762O8IWA10)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
  • TOCOPHEROL (UNII: R0ZB2556P8)

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.
  • 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: L'oreal Usa Products Inc
Labeler Code: 49967
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: 01-01-2020 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.

Vichy Laboratories Capital Soleil Uva Uvb 60 Titanium Dioxide 100% Mineral 15 Mineral Rich Water Ultra Lightweight Product Label Images

Vichy Laboratories Capital Soleil Uva Uvb 60 Titanium Dioxide 100% Mineral 15 Mineral Rich Water Ultra Lightweight 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 14.8%

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 sun

Warnings

For external use only

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 a Poison Control Center right away.

Directions

  • For sunscreen use:Shake well before useapply liberally 15 minutes before sun exposurereapply:   after 80 minutes of swimming of sweating   immediately after towel drying   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 sunstore at 68-77°F (20-25°C)

Inactive Ingredients

Water, isododecane, dimethicone, c12-15 alkyl benzoate, undecane, styrene/acrylates copolymer, caprylyl methicone, nylon-12, butyloctyl salicylate, phenethyl benzoate, dicaprylyl carbonate, silica, triethylhexanoin, isohexadecane, tridecane, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum hydroxide, stearic acid, PEG-9 polydimethylsiloxyethyl dimethicone, pentylene glycol, alumina, aluminum stearate, benzoic acid, benzyl benzoate, caprylyl glycol, dipropylene glycol, disodium stearoyl glutamate, disteardimonium hectorite, helianthus annuus (sunflower) seed oil, iron oxides, magnesium sulfate, PEG-8 laurate, phenoxyethanol, polyhydroxystearic acid, propylene carbonate, sodium citrate, sodium dodecylbenzenesulfonate, tocopherol

* Please review the disclaimer below.