Label: LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 1/BEIGE- octinoxate and zinc oxide liquid
LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 2/BEIGE- octinoxate and zinc oxide liquid
LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 3/BEIGE- octinoxate and zinc oxide liquid
LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 4/BEIGE- octinoxate and zinc oxide liquid
LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 5/BEIGE- octinoxate and zinc oxide liquid
LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 6/BEIGE- octinoxate and zinc oxide liquid
LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 7/BEIGE- octinoxate and zinc oxide liquid
LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 8/BEIGE- octinoxate and zinc oxide liquid
LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30 CLAIRE 9/BROWN- octinoxate and zinc oxide liquid

  • Contains inactivated NDC Code(s)
    NDC Code(s):     14783-213-01, 14783-213-02, 14783-214-01, 14783-214-02, view more
    14783-215-01, 14783-215-02, 14783-216-01, 14783-216-02, 14783-217-01, 14783-217-02, 14783-218-01, 14783-218-02, 14783-219-01, 14783-219-02, 14783-220-01, 14783-220-02, 14783-221-01, 14783-221-02
  • Packager: Ventura International LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 20, 2018

If you are a consumer or patient please visit this version.

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    OCTINOXATE 7.50 %Sunscreen
    ZINC 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.

    • 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

    • Apply liberally and evenly 15 minutes before sun exposure.
    • Reapply at least every 2 hours
    • Use 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.

  • SPL UNCLASSIFIED SECTION

    Dist. by Ventura Int Ltd. DBA Belcorp USA, Miami, FL 33126.

  • PRINCIPAL DISPLAY PANEL - 9 g Container Box - Claire 1/Beige

    L'BEL
    CLARITÉ
    Clarifying effect foundation SPF 30

    Net Wt. 0.31 oz. e (9 g)

    Principal Display Panel - 9 g Container Box - Claire 1/Beige
  • PRINCIPAL DISPLAY PANEL - 9 g Container Box - Claire 2/Beige

    L'BEL
    CLARITÉ
    Clarifying effect foundation SPF 30

    Net Wt. 0.31 oz. e (9 g)

    Principal Display Panel - 9 g Container Box - Claire 2/Beige
  • PRINCIPAL DISPLAY PANEL - 9 g Container Box - Claire 3/Beige

    L'BEL
    CLARITÉ
    Clarifying effect foundation SPF 30

    Net Wt. 0.31 oz. e (9 g)

    Principal Display Panel - 9 g Container Box - Claire 3/Beige
  • PRINCIPAL DISPLAY PANEL - 9 g Container Box - Claire 4/Beige

    L'BEL
    CLARITÉ
    Clarifying effect foundation SPF 30

    Net Wt. 0.31 oz. e (9 g)

    Principal Display Panel - 9 g Container Box - Claire 4/Beige
  • PRINCIPAL DISPLAY PANEL - 9 g Container Box - Claire 5/Beige

    L'BEL
    CLARITÉ
    Clarifying effect foundation SPF 30

    Net Wt. 0.31 oz. e (9 g)

    Principal Display Panel - 9 g Container Box - Claire 5/Beige
  • PRINCIPAL DISPLAY PANEL - 9 g Container Box - Claire 6/Beige

    L'BEL
    CLARITÉ
    Clarifying effect foundation SPF 30

    Net Wt. 0.31 oz. e (9 g)

    Principal Display Panel - 9 g Container Box - Claire 6/Beige
  • PRINCIPAL DISPLAY PANEL - 9 g Container Box - Claire 7/Beige

    L'BEL
    CLARITÉ
    Clarifying effect foundation SPF 30

    Net Wt. 0.31 oz. e (9 g)

    Principal Display Panel - 9 g Container Box - Claire 7/Beige
  • PRINCIPAL DISPLAY PANEL - 9 g Container Box - Claire 8/Beige

    L'BEL
    CLARITÉ
    Clarifying effect foundation SPF 30

    Net Wt. 0.31 oz. e (9 g)

    Principal Display Panel - 9 g Container Box - Claire 8/Beige
  • PRINCIPAL DISPLAY PANEL - 9 g Container Box - Claire 9/Brown

    L'BEL
    CLARITÉ
    Clarifying effect foundation SPF 30

    Net Wt. 0.31 oz. e (9 g)

    Principal Display Panel - 9 g Container Box - Claire 9/Brown
  • INGREDIENTS AND APPEARANCE
    LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30   CLAIRE 1/BEIGE
    octinoxate and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-213
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.0784 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-213-021 in 1 BOX12/26/2018
    1NDC:14783-213-019 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/26/2018
    LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30   CLAIRE 2/BEIGE
    octinoxate and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-214
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.0784 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-214-021 in 1 BOX12/26/2018
    1NDC:14783-214-019 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/26/2018
    LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30   CLAIRE 3/BEIGE
    octinoxate and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-215
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.0784 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-215-021 in 1 BOX12/26/2018
    1NDC:14783-215-019 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/26/2018
    LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30   CLAIRE 4/BEIGE
    octinoxate and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-217
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.0784 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-217-021 in 1 BOX12/26/2018
    1NDC:14783-217-019 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/26/2018
    LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30   CLAIRE 5/BEIGE
    octinoxate and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-218
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.0784 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-218-021 in 1 BOX12/26/2018
    1NDC:14783-218-019 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/26/2018
    LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30   CLAIRE 6/BEIGE
    octinoxate and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-219
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.0784 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-219-021 in 1 BOX12/26/2018
    1NDC:14783-219-019 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/26/2018
    LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30   CLAIRE 7/BEIGE
    octinoxate and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-220
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.0784 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-220-021 in 1 BOX12/26/2018
    1NDC:14783-220-019 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/26/2018
    LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30   CLAIRE 8/BEIGE
    octinoxate and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-221
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.0784 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-221-021 in 1 BOX12/26/2018
    1NDC:14783-221-019 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/26/2018
    LBEL CLARITE CLARIFYING EFFECT FOUNDATION SPF 30   CLAIRE 9/BROWN
    octinoxate and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-216
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.0784 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-216-021 in 1 BOX12/26/2018
    1NDC:14783-216-019 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/26/2018
    Labeler - Ventura International LTD (603192787)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(14783-213, 14783-214, 14783-215, 14783-217, 14783-218, 14783-219, 14783-220, 14783-221, 14783-216)
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