NDC 68745-2129 Ultra Le Teint Velvet Blurring Smooth-effect Foundation Velvet Matte Finish Broad Spectrum Spf 15 Sunscreen Bd121
Octinoxate And Titanium Dioxide
NDC Product Code 68745-2129
Proprietary Name: Ultra Le Teint Velvet Blurring Smooth-effect Foundation Velvet Matte Finish Broad Spectrum Spf 15 Sunscreen Bd121 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 And 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
- 68745 - Chanel Parfums Beaute
- 68745-2129 - Ultra Le Teint Velvet
NDC 68745-2129-1
Package Description: 1 BOTTLE in 1 CARTON > 30 mL in 1 BOTTLE
NDC 68745-2129-2
Package Description: 1 BOTTLE in 1 CARTON > 20 mL in 1 BOTTLE
NDC Product Information
Ultra Le Teint Velvet Blurring Smooth-effect Foundation Velvet Matte Finish Broad Spectrum Spf 15 Sunscreen Bd121 with NDC 68745-2129 is a a human over the counter drug product labeled by Chanel Parfums Beaute. The generic name of Ultra Le Teint Velvet Blurring Smooth-effect Foundation Velvet Matte Finish Broad Spectrum Spf 15 Sunscreen Bd121 is octinoxate and titanium dioxide. The product's dosage form is liquid and is administered via topical form.
Labeler Name: Chanel Parfums Beaute
Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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.
Ultra Le Teint Velvet Blurring Smooth-effect Foundation Velvet Matte Finish Broad Spectrum Spf 15 Sunscreen Bd121 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.
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)
- HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
- DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
- ALCOHOL (UNII: 3K9958V90M)
- METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
- POWDERED CELLULOSE (UNII: SMD1X3XO9M)
- PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
- ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
- PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)
- STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
- ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
- SODIUM CHLORIDE (UNII: 451W47IQ8X)
- STEARIC ACID (UNII: 4ELV7Z65AP)
- DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
- PHENOXYETHANOL (UNII: HIE492ZZ3T)
- PROPYLENE CARBONATE (UNII: 8D08K3S51E)
- TALC (UNII: 7SEV7J4R1U)
- SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
- BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
- LYSINE (UNII: K3Z4F929H6)
- MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
- BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
- TOCOPHEROL (UNII: R0ZB2556P8)
- HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
- TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
- HYDRATED SILICA (UNII: Y6O7T4G8P9)
- FERRIC OXIDE RED (UNII: 1K09F3G675)
- FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
- FERROSOFERRIC OXIDE (UNII: XM0M87F357)
- WATER (UNII: 059QF0KO0R)
- ISODODECANE (UNII: A8289P68Y2)
- DIMETHICONE (UNII: 92RU3N3Y1O)
- HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
- DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
- ALCOHOL (UNII: 3K9958V90M)
- METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
- POWDERED CELLULOSE (UNII: SMD1X3XO9M)
- PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
- ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
- PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)
- STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
- ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
- SODIUM CHLORIDE (UNII: 451W47IQ8X)
- STEARIC ACID (UNII: 4ELV7Z65AP)
- DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
- PHENOXYETHANOL (UNII: HIE492ZZ3T)
- PROPYLENE CARBONATE (UNII: 8D08K3S51E)
- TALC (UNII: 7SEV7J4R1U)
- SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
- BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
- LYSINE (UNII: K3Z4F929H6)
- MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
- BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
- TOCOPHEROL (UNII: R0ZB2556P8)
- HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
- TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
- HYDRATED SILICA (UNII: Y6O7T4G8P9)
- 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.
- 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: 08-15-2019 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.
Ultra Le Teint Velvet Blurring Smooth-effect Foundation Velvet Matte Finish Broad Spectrum Spf 15 Sunscreen Bd121 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
- Otc - Purpose
- Uses
- Warnings
- Otc - Do Not Use
- Otc - When Using
- Otc - Stop Use
- Otc - Keep Out Of Reach Of Children
- Directions
- Other Information
- Inactive Ingredients
Other
Drug Facts
Otc - Purpose
Active ingredientsPurposeOctinoxate 5%SunscreenTitanium dioxide 4.2%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 • isododecane • dimethicone • hydrogenated polyisobutene • dicaprylyl carbonate • alcohol • methyl methacrylate crosspolymer • cellulose • PEG-9 polydimethylsiloxyethyl dimethicone • isodecyl neopentanoate • propylene glycol dicaprylate • stearalkonium hectorite • aluminum hydroxide • sodium chloride • stearic acid • dimethicone/bis-isobutyl PPG-20 crosspolymer • phenoxyethanol • propylene carbonate • fragrance • talc • sodium lauroyl glutamate • biosaccharide gum-1 • lysine • trimethylsiloxysilicate/dimethiconol crosspolymer • magnesium chloride • BHT • tocopherol • hydrogenated lecithin • triethoxycaprylylsilane • hydrated silica (may contain) ultramarines • iron oxides • titanium dioxide • micail28a-i
* Please review the disclaimer below.