NDC 43596-0134 Lbel Clarite Clarifying Effect Foundation Spf 30 Claire 9/brown

Octinoxate And Zinc Oxide

NDC Product Code 43596-0134

NDC 43596-0134-2

Package Description: 1 CONTAINER in 1 BOX > 9 g in 1 CONTAINER (43596-0134-1)

NDC Product Information

Lbel Clarite Clarifying Effect Foundation Spf 30 Claire 9/brown with NDC 43596-0134 is a a human over the counter drug product labeled by Ventura Corporation Ltd. The generic name of Lbel Clarite Clarifying Effect Foundation Spf 30 Claire 9/brown is octinoxate and zinc oxide. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Ventura Corporation Ltd

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.

Lbel Clarite Clarifying Effect Foundation Spf 30 Claire 9/brown 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 .075 g/g
  • ZINC OXIDE .0784 g/g

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.

  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • MICA (UNII: V8A1AW0880)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • KOJIC DIPALMITATE (UNII: 13N249RWTM)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • LICORICE (UNII: 61ZBX54883)
  • DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
  • HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
  • .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
  • ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • MICA (UNII: V8A1AW0880)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • KOJIC DIPALMITATE (UNII: 13N249RWTM)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • LICORICE (UNII: 61ZBX54883)
  • DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
  • HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
  • .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
  • ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • MICA (UNII: V8A1AW0880)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • KOJIC DIPALMITATE (UNII: 13N249RWTM)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • LICORICE (UNII: 61ZBX54883)
  • DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
  • HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
  • .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
  • ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • MICA (UNII: V8A1AW0880)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • KOJIC DIPALMITATE (UNII: 13N249RWTM)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • LICORICE (UNII: 61ZBX54883)
  • DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
  • HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
  • .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
  • ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • MICA (UNII: V8A1AW0880)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • KOJIC DIPALMITATE (UNII: 13N249RWTM)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • LICORICE (UNII: 61ZBX54883)
  • DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
  • HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
  • .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
  • ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • MICA (UNII: V8A1AW0880)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • KOJIC DIPALMITATE (UNII: 13N249RWTM)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • LICORICE (UNII: 61ZBX54883)
  • DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
  • HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
  • .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
  • ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • MICA (UNII: V8A1AW0880)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • KOJIC DIPALMITATE (UNII: 13N249RWTM)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • LICORICE (UNII: 61ZBX54883)
  • DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
  • HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
  • .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
  • ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • MICA (UNII: V8A1AW0880)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • KOJIC DIPALMITATE (UNII: 13N249RWTM)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • LICORICE (UNII: 61ZBX54883)
  • DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
  • HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
  • .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
  • ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • MICA (UNII: V8A1AW0880)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • KOJIC DIPALMITATE (UNII: 13N249RWTM)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • LICORICE (UNII: 61ZBX54883)
  • DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
  • HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
  • .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
  • ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • 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: Ventura Corporation Ltd
Labeler Code: 43596
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 09-26-2018 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 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.

Lbel Clarite Clarifying Effect Foundation Spf 30 Claire 9/brown 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

Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926.

Otc - Purpose

Active IngredientsPurposeOCTINOXATE 7.50 %SunscreenZINC OXIDE 7.84 %Sunscreen

Uses

  • Helps prevent sunburn.

Warnings

  • Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.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 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

  • Apply liberally and evenly 15 minutes before sun exposure.Reapply at least every 2 hoursUse a water resistant sunscreen if swimming or sweating.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

Dimethicone, mica, zea mays (corn) starch, ozokerite, polyethylene, silica dimethyl silylate, peg/ppg-18/18 dimethicone, copernicia cerifera (carnauba) wax, kojic dipalmitate, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, hexyl laurate, phenoxyethanol, triethoxycaprylylsilane, caprylyl glycol, chlorphenesin, fragrante, glycyrrhiza glabra (licorice) root extract, trimethylsiloxysilicate, dimethylmethoxy chromanyl palmitato, citronellol, butylphenyl methylpropional, hydroxycitronellal, hexyl cinnamal, d-limonene, hydroxyisohexyl 3-cyclohexene carboxaldehyde, alpha-isomethyl ionone.May Contain: titanium dioxide, iron oxides.

* Please review the disclaimer below.