Label: LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 1) - BEIGE- zinc oxide liquid
LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 2) - BEIGE- zinc oxide liquid
LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 3) - BEIGE- zinc oxide liquid
LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 4) - BEIGE- zinc oxide liquid
LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (MEDIUM 5) - BROWN- zinc oxide liquid
LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (MEDIUM 6) - BROWN- zinc oxide liquid
LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (MEDIUM 7) - BROWN- zinc oxide liquid
LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (OBSCURE 8) - BROWN- zinc oxide liquid
LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (OBSCURE 9) - BROWN- zinc oxide liquid

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    14783-266-01, 14783-266-02, 14783-266-03, 14783-266-04, view more
    14783-267-05, 14783-267-06, 14783-267-07, 14783-267-08, 14783-268-09, 14783-268-10, 14783-268-11, 14783-268-12, 14783-269-13, 14783-269-14, 14783-269-15, 14783-269-16, 14783-270-17, 14783-270-18, 14783-270-19, 14783-270-20, 14783-271-21, 14783-271-22, 14783-271-23, 14783-271-24, 14783-272-25, 14783-272-26, 14783-272-27, 14783-272-28, 14783-273-29, 14783-273-30, 14783-273-31, 14783-273-32, 14783-274-33, 14783-274-34, 14783-274-35, 14783-274-36
  • 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 18, 2013

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Zinc oxide 1.6%

  • Purpose

    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

    • 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
    • Apply to the forehead, nose, chin and both cheeks. Blend with Circular motion and spread softly without stretching the skin
  • Other information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients

    Water, cyclopentasiloxane, trimethylsiloxysilicate, dimethicone, polymethyl methacrylate, peg/ppg-18/18 dimethicone, cyclohexasiloxane, methyl methacrylate crosspolymer, sodium chloride, bis-hydroxyethoxypropyl dimethicone, bis-peg-18 methyl ether dimethyl silane, peg/ppg-19/19 dimethicone, glycerin, oleth-5, phenyl trimethicone, hydrolyzed soy protein, propylene glycol, silica silylate, mica, methylparaben, triethoxycaprylylsilane, propylparaben, tocopheryl acetate, phenoxyethanol, fragrance, butylparaben, ethylparaben, silica, isobutylparaben.

  • May contain

    Titanium dioxide, iron oxides, iron oxides, iron oxides, bismuth oxychloride.

  • SPL UNCLASSIFIED SECTION

    Distributed by Ventura International Ltd. DBA Belcorp USA, San Francisco, CA 94111

  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - (Claire 1) - Beige

    EFFET
    PARFAIT

    maximum comfort
    and long-lasting
    foundation
    SPF 10

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 ml Bottle Box - (Claire 1) - Beige
  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - (Claire 2) - Beige

    EFFET
    PARFAIT

    maximum comfort
    and long-lasting
    foundation
    SPF 10

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 ml Bottle Box - (Claire 2) - Beige
  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - (Claire 3) - Beige

    EFFET
    PARFAIT

    maximum comfort
    and long-lasting
    foundation
    SPF 10

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 ml Bottle Box - (Claire 3) - Beige
  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - (Claire 4) - Beige

    EFFET
    PARFAIT

    maximum comfort
    and long-lasting
    foundation
    SPF 10

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 ml Bottle Box - (Claire 4) - Beige
  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - (Medium 5) - Brown

    EFFET
    PARFAIT

    maximum comfort
    and long-lasting
    foundation
    SPF 10

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 ml Bottle Box - (Medium 5) - Brown
  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - (Medium 6) - Brown

    EFFET
    PARFAIT

    maximum comfort
    and long-lasting
    foundation
    SPF 10

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 ml Bottle Box - (Medium 6) - Brown
  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - (Medium 7) - Brown

    EFFET
    PARFAIT

    maximum comfort
    and long-lasting
    foundation
    SPF 10

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 ml Bottle Box - (Medium 7) - Brown
  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - (Obscure 8) - Brown

    EFFET
    PARFAIT

    maximum comfort
    and long-lasting
    foundation
    SPF 10

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 ml Bottle Box - (Obscure 8) - Brown
  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - (Obscure 9) - Brown

    EFFET
    PARFAIT

    maximum comfort
    and long-lasting
    foundation
    SPF 10

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 ml Bottle Box - (Obscure 9) - Brown
  • INGREDIENTS AND APPEARANCE
    LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10   (CLAIRE 1) - BEIGE
    zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-266
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    dimethicone (UNII: 92RU3N3Y1O)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    sodium chloride (UNII: 451W47IQ8X)  
    bis-peg-18 methyl ether dimethyl silane (UNII: OEB4R3WW9C)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    glycerin (UNII: PDC6A3C0OX)  
    oleth-5 (UNII: 1GH33785AY)  
    phenyl trimethicone (UNII: DR0K5NOJ4R)  
    propylene glycol (UNII: 6DC9Q167V3)  
    mica (UNII: V8A1AW0880)  
    methylparaben (UNII: A2I8C7HI9T)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    propylparaben (UNII: Z8IX2SC1OH)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    bismuth oxychloride (UNII: 4ZR792I587)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-266-021 in 1 BOX
    1NDC:14783-266-0130 mL in 1 BOTTLE, PLASTIC
    2NDC:14783-266-041 in 1 BOX
    2NDC:14783-266-033 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10   (CLAIRE 2) - BEIGE
    zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-267
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    dimethicone (UNII: 92RU3N3Y1O)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    sodium chloride (UNII: 451W47IQ8X)  
    bis-peg-18 methyl ether dimethyl silane (UNII: OEB4R3WW9C)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    glycerin (UNII: PDC6A3C0OX)  
    oleth-5 (UNII: 1GH33785AY)  
    phenyl trimethicone (UNII: DR0K5NOJ4R)  
    propylene glycol (UNII: 6DC9Q167V3)  
    mica (UNII: V8A1AW0880)  
    methylparaben (UNII: A2I8C7HI9T)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    propylparaben (UNII: Z8IX2SC1OH)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    bismuth oxychloride (UNII: 4ZR792I587)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-267-061 in 1 BOX
    1NDC:14783-267-0530 mL in 1 BOTTLE, PLASTIC
    2NDC:14783-267-081 in 1 BOX
    2NDC:14783-267-073 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10   (CLAIRE 3) - BEIGE
    zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-268
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    dimethicone (UNII: 92RU3N3Y1O)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    sodium chloride (UNII: 451W47IQ8X)  
    bis-peg-18 methyl ether dimethyl silane (UNII: OEB4R3WW9C)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    glycerin (UNII: PDC6A3C0OX)  
    oleth-5 (UNII: 1GH33785AY)  
    phenyl trimethicone (UNII: DR0K5NOJ4R)  
    propylene glycol (UNII: 6DC9Q167V3)  
    mica (UNII: V8A1AW0880)  
    methylparaben (UNII: A2I8C7HI9T)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    propylparaben (UNII: Z8IX2SC1OH)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    bismuth oxychloride (UNII: 4ZR792I587)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-268-101 in 1 BOX
    1NDC:14783-268-0930 mL in 1 BOTTLE, PLASTIC
    2NDC:14783-268-121 in 1 BOX
    2NDC:14783-268-113 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10   (CLAIRE 4) - BEIGE
    zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-269
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    dimethicone (UNII: 92RU3N3Y1O)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    sodium chloride (UNII: 451W47IQ8X)  
    bis-peg-18 methyl ether dimethyl silane (UNII: OEB4R3WW9C)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    glycerin (UNII: PDC6A3C0OX)  
    oleth-5 (UNII: 1GH33785AY)  
    phenyl trimethicone (UNII: DR0K5NOJ4R)  
    propylene glycol (UNII: 6DC9Q167V3)  
    mica (UNII: V8A1AW0880)  
    methylparaben (UNII: A2I8C7HI9T)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    propylparaben (UNII: Z8IX2SC1OH)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    bismuth oxychloride (UNII: 4ZR792I587)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-269-141 in 1 BOX
    1NDC:14783-269-1330 mL in 1 BOTTLE, PLASTIC
    2NDC:14783-269-161 in 1 BOX
    2NDC:14783-269-153 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10   (MEDIUM 5) - BROWN
    zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-270
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    dimethicone (UNII: 92RU3N3Y1O)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    sodium chloride (UNII: 451W47IQ8X)  
    bis-peg-18 methyl ether dimethyl silane (UNII: OEB4R3WW9C)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    glycerin (UNII: PDC6A3C0OX)  
    oleth-5 (UNII: 1GH33785AY)  
    phenyl trimethicone (UNII: DR0K5NOJ4R)  
    propylene glycol (UNII: 6DC9Q167V3)  
    mica (UNII: V8A1AW0880)  
    methylparaben (UNII: A2I8C7HI9T)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    propylparaben (UNII: Z8IX2SC1OH)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    bismuth oxychloride (UNII: 4ZR792I587)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-270-181 in 1 BOX
    1NDC:14783-270-1730 mL in 1 BOTTLE, PLASTIC
    2NDC:14783-270-201 in 1 BOX
    2NDC:14783-270-193 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10   (MEDIUM 6) - BROWN
    zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-271
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    dimethicone (UNII: 92RU3N3Y1O)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    sodium chloride (UNII: 451W47IQ8X)  
    bis-peg-18 methyl ether dimethyl silane (UNII: OEB4R3WW9C)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    glycerin (UNII: PDC6A3C0OX)  
    oleth-5 (UNII: 1GH33785AY)  
    phenyl trimethicone (UNII: DR0K5NOJ4R)  
    propylene glycol (UNII: 6DC9Q167V3)  
    mica (UNII: V8A1AW0880)  
    methylparaben (UNII: A2I8C7HI9T)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    propylparaben (UNII: Z8IX2SC1OH)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    bismuth oxychloride (UNII: 4ZR792I587)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-271-221 in 1 BOX
    1NDC:14783-271-2130 mL in 1 BOTTLE, PLASTIC
    2NDC:14783-271-241 in 1 BOX
    2NDC:14783-271-233 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10   (MEDIUM 7) - BROWN
    zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-272
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    dimethicone (UNII: 92RU3N3Y1O)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    sodium chloride (UNII: 451W47IQ8X)  
    bis-peg-18 methyl ether dimethyl silane (UNII: OEB4R3WW9C)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    glycerin (UNII: PDC6A3C0OX)  
    oleth-5 (UNII: 1GH33785AY)  
    phenyl trimethicone (UNII: DR0K5NOJ4R)  
    propylene glycol (UNII: 6DC9Q167V3)  
    mica (UNII: V8A1AW0880)  
    methylparaben (UNII: A2I8C7HI9T)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    propylparaben (UNII: Z8IX2SC1OH)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    bismuth oxychloride (UNII: 4ZR792I587)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-272-261 in 1 BOX
    1NDC:14783-272-2530 mL in 1 BOTTLE, PLASTIC
    2NDC:14783-272-281 in 1 BOX
    2NDC:14783-272-273 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10   (OBSCURE 8) - BROWN
    zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-273
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    dimethicone (UNII: 92RU3N3Y1O)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    sodium chloride (UNII: 451W47IQ8X)  
    bis-peg-18 methyl ether dimethyl silane (UNII: OEB4R3WW9C)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    glycerin (UNII: PDC6A3C0OX)  
    oleth-5 (UNII: 1GH33785AY)  
    phenyl trimethicone (UNII: DR0K5NOJ4R)  
    propylene glycol (UNII: 6DC9Q167V3)  
    mica (UNII: V8A1AW0880)  
    methylparaben (UNII: A2I8C7HI9T)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    propylparaben (UNII: Z8IX2SC1OH)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    bismuth oxychloride (UNII: 4ZR792I587)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-273-301 in 1 BOX
    1NDC:14783-273-2930 mL in 1 BOTTLE, PLASTIC
    2NDC:14783-273-321 in 1 BOX
    2NDC:14783-273-313 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10   (OBSCURE 9) - BROWN
    zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-274
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    dimethicone (UNII: 92RU3N3Y1O)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    sodium chloride (UNII: 451W47IQ8X)  
    bis-peg-18 methyl ether dimethyl silane (UNII: OEB4R3WW9C)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    glycerin (UNII: PDC6A3C0OX)  
    oleth-5 (UNII: 1GH33785AY)  
    phenyl trimethicone (UNII: DR0K5NOJ4R)  
    propylene glycol (UNII: 6DC9Q167V3)  
    mica (UNII: V8A1AW0880)  
    methylparaben (UNII: A2I8C7HI9T)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    propylparaben (UNII: Z8IX2SC1OH)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    bismuth oxychloride (UNII: 4ZR792I587)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-274-341 in 1 BOX
    1NDC:14783-274-3330 mL in 1 BOTTLE, PLASTIC
    2NDC:14783-274-361 in 1 BOX
    2NDC:14783-274-353 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    Labeler - Ventura International LTD (603192787)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(14783-266, 14783-267, 14783-268, 14783-269, 14783-270, 14783-271, 14783-272, 14783-273, 14783-274)