Label: LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (CLAIRE 1) - BEIGE- octinoxate and titanium dioxide liquid
LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (CLAIRE 2) - BEIGE- octinoxate and titanium dioxide liquid
LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (CLAIRE 3) - BEIGE- octinoxate and titanium dioxide liquid
LBEL NATURAL FINISH .......tanium dioxide) liquid
LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 8C) - BROWN- octinoxate and titanium dioxide liquid
LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 10) - BROWN- octinoxate and titanium dioxide liquid
LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (DORE 6) - BEIGE- octinoxate and titanium dioxide liquid

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    13537-241-01, 13537-241-02, 13537-241-03, 13537-241-04, view more
    13537-241-05, 13537-241-06, 13537-241-07, 13537-241-08, 13537-242-01, 13537-242-02, 13537-242-03, 13537-242-04, 13537-242-05, 13537-242-06, 13537-242-07, 13537-242-08, 13537-243-01, 13537-243-02, 13537-243-03, 13537-243-04, 13537-243-05, 13537-243-06, 13537-243-07, 13537-243-08, 13537-244-01, 13537-244-02, 13537-244-03, 13537-244-04, 13537-244-05, 13537-244-06, 13537-244-07, 13537-244-08, 13537-245-01, 13537-245-02, 13537-245-03, 13537-245-04, 13537-245-05, 13537-245-06, 13537-245-07, 13537-245-08, 13537-246-01, 13537-246-02, 13537-246-03, 13537-246-04, 13537-246-05, 13537-246-06, 13537-246-07, 13537-246-08, 13537-247-01, 13537-247-02, 13537-247-03, 13537-247-04, 13537-247-05, 13537-247-06, 13537-247-07, 13537-247-08, 13537-248-01, 13537-248-02, 13537-248-03, 13537-248-04, 13537-248-05, 13537-248-06, 13537-248-07, 13537-248-08, 13537-249-01, 13537-249-02, 13537-249-03, 13537-249-04, 13537-249-05, 13537-249-06, 13537-249-07, 13537-249-08, 13537-251-01, 13537-251-02, 13537-251-03, 13537-251-04, 13537-251-05, 13537-251-06, 13537-251-07, 13537-251-08, 13537-252-01, 13537-252-02, 13537-252-03, 13537-252-04, 13537-252-05, 13537-252-06, 13537-252-07, 13537-252-08, 13537-253-01, 13537-253-02, 13537-253-03, 13537-253-04, 13537-253-05, 13537-253-06, 13537-253-07, 13537-253-08, 13537-254-01, 13537-254-02, 13537-254-03, 13537-254-04, 13537-254-05, 13537-254-06, 13537-254-07, 13537-254-08, 13537-255-01, 13537-255-02, 13537-255-03, 13537-255-04, 13537-255-05, 13537-255-06, 13537-255-07, 13537-255-08, 13537-256-01, 13537-256-02, 13537-256-03, 13537-256-04, 13537-256-05, 13537-256-06, 13537-256-07, 13537-256-08, 13537-299-01, 13537-299-02, 13537-299-03, 13537-299-04, 13537-299-05, 13537-299-06, 13537-299-07, 13537-299-08
  • Packager: Ventura Corporation LTD
  • Category: HUMAN OTC DRUG LABEL

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 19, 2013

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Octinoxate 6.5 %Sunscreen
    Titanium Dioxide 1.6%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

    Water, cyclopentasiloxane, cyclohexasiloxane, propylene glycol dicaprylate/dicaprate, peg/ppg-18/18 dimethicone, trimethylsiloxysilicate, dimethicone/vinyl dimethicone crosspolymer, xylitylglucoside, octyldodecanol, oleth-5, polymethyl methacrylate, anhydroxylitol, glycerin, linoleic acid, peg/ppg-19/19 dimethicone, microcrystalline wax, c12-15 alkyl benzoate, xylitol, diazolidinyl urea, alumina, petrolatum, tocopheryl acetate, triethoxycaprylylsilane, phospholipids, ribes nigrum (black currant) seed oil, silica, methylparaben, propylparaben, fragrance, copernicia cerifera (carnauba) wax, tribehenin, cholesterol, methicone, bht, menthoxypropanediol, euphorbia cerifera (candelilla) wax, beeswax, cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, glycosphingolipids, ceramide 2, decyl glucoside, linolenic acid, peg-10 rapeseed sterol, palmitoyl oligopeptide.

    May contain:

    Titanium dioxide, iron oxides , iron oxides, iron oxides.

  • SPL UNCLASSIFIED SECTION

    PR: Distributed by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.

  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Claire 1) - Beige

    EFFET
    PARFAIT

    natural finish
    moisturizing
    foundation
    SPF 25

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 mL Tube Carton - (Claire 1) - Beige
  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Claire 2) - Beige

    EFFET
    PARFAIT

    natural finish
    moisturizing
    foundation
    SPF 25

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 mL Tube Carton - (Claire 2) - Beige
  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Claire 3) - Beige

    EFFET
    PARFAIT

    natural finish
    moisturizing
    foundation
    SPF 25

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 mL Tube Carton - (Claire 3) - Beige
  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Claire 4) - Beige

    EFFET
    PARFAIT

    natural finish
    moisturizing
    foundation
    SPF 25

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 mL Tube Carton - (Claire 4) - Beige
  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Medium 5) - Brown

    EFFET
    PARFAIT

    natural finish
    moisturizing
    foundation
    SPF 25

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 mL Tube Carton - (Medium 5) - Brown
  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Medium 6) - Brown

    EFFET
    PARFAIT

    natural finish
    moisturizing
    foundation
    SPF 25

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 mL Tube Carton - (Medium 6) - Brown
  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Medium 7) - Brown

    EFFET
    PARFAIT

    natural finish
    moisturizing
    foundation
    SPF 25

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 mL Tube Carton - (Medium 7) - Brown
  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Obscure 8) - Brown

    EFFET
    PARFAIT

    natural finish
    moisturizing
    foundation
    SPF 25

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 mL Tube Carton - (Obscure 8) - Brown
  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Obscure 9) - Brown

    EFFET
    PARFAIT

    natural finish
    moisturizing
    foundation
    SPF 25

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 mL Tube Carton - (Obscure 9) - Brown
  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Medium 6A) - Brown

    EFFET
    PARFAIT

    natural finish
    moisturizing
    foundation
    SPF 25

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 mL Tube Carton - (Medium 6A) - Brown
  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Medium 6B) - Brown

    EFFET
    PARFAIT

    natural finish
    moisturizing
    foundation
    SPF 25

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 mL Tube Carton - (Medium 6B) - Brown
  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Obscure 8A) - Brown

    EFFET
    PARFAIT

    natural finish
    moisturizing
    foundation
    SPF 25

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 mL Tube Carton - (Obscure 8A) - Brown
  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Obscure 8B) - Brown

    EFFET
    PARFAIT

    natural finish
    moisturizing
    foundation
    SPF 25

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 mL Tube Carton - (Obscure 8B) - Brown
  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Obscure 8C) - Brown

    EFFET
    PARFAIT

    natural finish
    moisturizing
    foundation
    SPF 25

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 mL Tube Carton - (Obscure 8C) - Brown
  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Obscure 10) - Brown

    EFFET
    PARFAIT

    natural finish
    moisturizing
    foundation
    SPF 25

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 mL Tube Carton - (Obscure 10) - Brown
  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Dore 6) - Beige

    EFFET
    PARFAIT

    natural finish
    moisturizing
    foundation
    SPF 25

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 mL Tube Carton - (Dore 6) - Beige
  • INGREDIENTS AND APPEARANCE
    LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (CLAIRE 1) - BEIGE
    octinoxate and titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-241
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    xylitylglucoside (UNII: O0IEZ166FB)  
    octyldodecanol (UNII: 461N1O614Y)  
    oleth-5 (UNII: 1GH33785AY)  
    anhydroxylitol (UNII: 8XWR7NN42F)  
    glycerin (UNII: PDC6A3C0OX)  
    linoleic acid (UNII: 9KJL21T0QJ)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
    xylitol (UNII: VCQ006KQ1E)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    aluminum oxide (UNII: LMI26O6933)  
    petrolatum (UNII: 4T6H12BN9U)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    ribes nigrum seed oil (UNII: GKE1188837)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    carnauba wax (UNII: R12CBM0EIZ)  
    tribehenin (UNII: 8OC9U7TQZ0)  
    cholesterol (UNII: 97C5T2UQ7J)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    ceramide 2 (UNII: C04977SRJ5)  
    decyl glucoside (UNII: Z17H97EA6Y)  
    linolenic acid (UNII: 0RBV727H71)  
    peg-10 rapeseed sterol (UNII: 258O76T85M)  
    palmitoyl oligopeptide (UNII: HO4ZT5S86C)  
    ferric oxide red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-241-021 in 1 BOX
    1NDC:13537-241-0130 mL in 1 BOTTLE, PLASTIC
    2NDC:13537-241-041 in 1 BOX
    2NDC:13537-241-0327 mL in 1 BOTTLE, PLASTIC
    3NDC:13537-241-061 in 1 BOX
    3NDC:13537-241-054.5 mL in 1 BOTTLE, PLASTIC
    4NDC:13537-241-081 in 1 BOX
    4NDC:13537-241-073 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (CLAIRE 2) - BEIGE
    octinoxate and titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-242
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    xylitylglucoside (UNII: O0IEZ166FB)  
    octyldodecanol (UNII: 461N1O614Y)  
    oleth-5 (UNII: 1GH33785AY)  
    anhydroxylitol (UNII: 8XWR7NN42F)  
    glycerin (UNII: PDC6A3C0OX)  
    linoleic acid (UNII: 9KJL21T0QJ)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
    xylitol (UNII: VCQ006KQ1E)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    aluminum oxide (UNII: LMI26O6933)  
    petrolatum (UNII: 4T6H12BN9U)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    ribes nigrum seed oil (UNII: GKE1188837)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    carnauba wax (UNII: R12CBM0EIZ)  
    tribehenin (UNII: 8OC9U7TQZ0)  
    cholesterol (UNII: 97C5T2UQ7J)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    ceramide 2 (UNII: C04977SRJ5)  
    decyl glucoside (UNII: Z17H97EA6Y)  
    linolenic acid (UNII: 0RBV727H71)  
    peg-10 rapeseed sterol (UNII: 258O76T85M)  
    palmitoyl oligopeptide (UNII: HO4ZT5S86C)  
    ferric oxide red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-242-021 in 1 BOX
    1NDC:13537-242-0130 mL in 1 BOTTLE, PLASTIC
    2NDC:13537-242-041 in 1 BOX
    2NDC:13537-242-0327 mL in 1 BOTTLE, PLASTIC
    3NDC:13537-242-061 in 1 BOX
    3NDC:13537-242-054.5 mL in 1 BOTTLE, PLASTIC
    4NDC:13537-242-081 in 1 BOX
    4NDC:13537-242-073 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (CLAIRE 3) - BEIGE
    octinoxate and titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-243
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    xylitylglucoside (UNII: O0IEZ166FB)  
    octyldodecanol (UNII: 461N1O614Y)  
    oleth-5 (UNII: 1GH33785AY)  
    anhydroxylitol (UNII: 8XWR7NN42F)  
    glycerin (UNII: PDC6A3C0OX)  
    linoleic acid (UNII: 9KJL21T0QJ)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
    xylitol (UNII: VCQ006KQ1E)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    aluminum oxide (UNII: LMI26O6933)  
    petrolatum (UNII: 4T6H12BN9U)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    ribes nigrum seed oil (UNII: GKE1188837)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    carnauba wax (UNII: R12CBM0EIZ)  
    tribehenin (UNII: 8OC9U7TQZ0)  
    cholesterol (UNII: 97C5T2UQ7J)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    ceramide 2 (UNII: C04977SRJ5)  
    decyl glucoside (UNII: Z17H97EA6Y)  
    linolenic acid (UNII: 0RBV727H71)  
    peg-10 rapeseed sterol (UNII: 258O76T85M)  
    palmitoyl oligopeptide (UNII: HO4ZT5S86C)  
    ferric oxide red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-243-021 in 1 BOX
    1NDC:13537-243-0130 mL in 1 BOTTLE, PLASTIC
    2NDC:13537-243-041 in 1 BOX
    2NDC:13537-243-0327 mL in 1 BOTTLE, PLASTIC
    3NDC:13537-243-061 in 1 BOX
    3NDC:13537-243-054.5 mL in 1 BOTTLE, PLASTIC
    4NDC:13537-243-081 in 1 BOX
    4NDC:13537-243-073 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (CLAIRE 4) - BEIGE
    octinoxate and titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-244
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    xylitylglucoside (UNII: O0IEZ166FB)  
    octyldodecanol (UNII: 461N1O614Y)  
    oleth-5 (UNII: 1GH33785AY)  
    anhydroxylitol (UNII: 8XWR7NN42F)  
    glycerin (UNII: PDC6A3C0OX)  
    linoleic acid (UNII: 9KJL21T0QJ)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
    xylitol (UNII: VCQ006KQ1E)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    aluminum oxide (UNII: LMI26O6933)  
    petrolatum (UNII: 4T6H12BN9U)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    ribes nigrum seed oil (UNII: GKE1188837)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    carnauba wax (UNII: R12CBM0EIZ)  
    tribehenin (UNII: 8OC9U7TQZ0)  
    cholesterol (UNII: 97C5T2UQ7J)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    ceramide 2 (UNII: C04977SRJ5)  
    decyl glucoside (UNII: Z17H97EA6Y)  
    linolenic acid (UNII: 0RBV727H71)  
    peg-10 rapeseed sterol (UNII: 258O76T85M)  
    palmitoyl oligopeptide (UNII: HO4ZT5S86C)  
    ferric oxide red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-244-021 in 1 BOX
    1NDC:13537-244-0130 mL in 1 BOTTLE, PLASTIC
    2NDC:13537-244-041 in 1 BOX
    2NDC:13537-244-0327 mL in 1 BOTTLE, PLASTIC
    3NDC:13537-244-061 in 1 BOX
    3NDC:13537-244-054.5 mL in 1 BOTTLE, PLASTIC
    4NDC:13537-244-081 in 1 BOX
    4NDC:13537-244-073 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (MEDIUM 5) - BROWN
    octinoxate and titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-245
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    xylitylglucoside (UNII: O0IEZ166FB)  
    octyldodecanol (UNII: 461N1O614Y)  
    oleth-5 (UNII: 1GH33785AY)  
    anhydroxylitol (UNII: 8XWR7NN42F)  
    glycerin (UNII: PDC6A3C0OX)  
    linoleic acid (UNII: 9KJL21T0QJ)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
    xylitol (UNII: VCQ006KQ1E)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    aluminum oxide (UNII: LMI26O6933)  
    petrolatum (UNII: 4T6H12BN9U)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    ribes nigrum seed oil (UNII: GKE1188837)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    carnauba wax (UNII: R12CBM0EIZ)  
    tribehenin (UNII: 8OC9U7TQZ0)  
    cholesterol (UNII: 97C5T2UQ7J)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    ceramide 2 (UNII: C04977SRJ5)  
    decyl glucoside (UNII: Z17H97EA6Y)  
    linolenic acid (UNII: 0RBV727H71)  
    peg-10 rapeseed sterol (UNII: 258O76T85M)  
    palmitoyl oligopeptide (UNII: HO4ZT5S86C)  
    ferric oxide red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-245-021 in 1 BOX
    1NDC:13537-245-0130 mL in 1 BOTTLE, PLASTIC
    2NDC:13537-245-041 in 1 BOX
    2NDC:13537-245-0327 mL in 1 BOTTLE, PLASTIC
    3NDC:13537-245-061 in 1 BOX
    3NDC:13537-245-054.5 mL in 1 BOTTLE, PLASTIC
    4NDC:13537-245-081 in 1 BOX
    4NDC:13537-245-073 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (MEDIUM 6) - BROWN
    octinoxate and titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-246
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    xylitylglucoside (UNII: O0IEZ166FB)  
    octyldodecanol (UNII: 461N1O614Y)  
    oleth-5 (UNII: 1GH33785AY)  
    anhydroxylitol (UNII: 8XWR7NN42F)  
    glycerin (UNII: PDC6A3C0OX)  
    linoleic acid (UNII: 9KJL21T0QJ)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
    xylitol (UNII: VCQ006KQ1E)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    aluminum oxide (UNII: LMI26O6933)  
    petrolatum (UNII: 4T6H12BN9U)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    ribes nigrum seed oil (UNII: GKE1188837)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    carnauba wax (UNII: R12CBM0EIZ)  
    tribehenin (UNII: 8OC9U7TQZ0)  
    cholesterol (UNII: 97C5T2UQ7J)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    ceramide 2 (UNII: C04977SRJ5)  
    decyl glucoside (UNII: Z17H97EA6Y)  
    linolenic acid (UNII: 0RBV727H71)  
    peg-10 rapeseed sterol (UNII: 258O76T85M)  
    palmitoyl oligopeptide (UNII: HO4ZT5S86C)  
    ferric oxide red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-246-021 in 1 BOX
    1NDC:13537-246-0130 mL in 1 BOTTLE, PLASTIC
    2NDC:13537-246-041 in 1 BOX
    2NDC:13537-246-0327 mL in 1 BOTTLE, PLASTIC
    3NDC:13537-246-061 in 1 BOX
    3NDC:13537-246-054.5 mL in 1 BOTTLE, PLASTIC
    4NDC:13537-246-081 in 1 BOX
    4NDC:13537-246-073 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (MEDIUM 7) - BROWN
    octinoxate and titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-247
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    xylitylglucoside (UNII: O0IEZ166FB)  
    octyldodecanol (UNII: 461N1O614Y)  
    oleth-5 (UNII: 1GH33785AY)  
    anhydroxylitol (UNII: 8XWR7NN42F)  
    glycerin (UNII: PDC6A3C0OX)  
    linoleic acid (UNII: 9KJL21T0QJ)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
    xylitol (UNII: VCQ006KQ1E)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    aluminum oxide (UNII: LMI26O6933)  
    petrolatum (UNII: 4T6H12BN9U)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    ribes nigrum seed oil (UNII: GKE1188837)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    carnauba wax (UNII: R12CBM0EIZ)  
    tribehenin (UNII: 8OC9U7TQZ0)  
    cholesterol (UNII: 97C5T2UQ7J)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    ceramide 2 (UNII: C04977SRJ5)  
    decyl glucoside (UNII: Z17H97EA6Y)  
    linolenic acid (UNII: 0RBV727H71)  
    peg-10 rapeseed sterol (UNII: 258O76T85M)  
    palmitoyl oligopeptide (UNII: HO4ZT5S86C)  
    ferric oxide red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-247-021 in 1 BOX
    1NDC:13537-247-0130 mL in 1 BOTTLE, PLASTIC
    2NDC:13537-247-041 in 1 BOX
    2NDC:13537-247-0327 mL in 1 BOTTLE, PLASTIC
    3NDC:13537-247-061 in 1 BOX
    3NDC:13537-247-054.5 mL in 1 BOTTLE, PLASTIC
    4NDC:13537-247-081 in 1 BOX
    4NDC:13537-247-073 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (OBSCURE 8) - BROWN
    octinoxate and titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-248
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    xylitylglucoside (UNII: O0IEZ166FB)  
    octyldodecanol (UNII: 461N1O614Y)  
    oleth-5 (UNII: 1GH33785AY)  
    anhydroxylitol (UNII: 8XWR7NN42F)  
    glycerin (UNII: PDC6A3C0OX)  
    linoleic acid (UNII: 9KJL21T0QJ)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
    xylitol (UNII: VCQ006KQ1E)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    aluminum oxide (UNII: LMI26O6933)  
    petrolatum (UNII: 4T6H12BN9U)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    ribes nigrum seed oil (UNII: GKE1188837)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    carnauba wax (UNII: R12CBM0EIZ)  
    tribehenin (UNII: 8OC9U7TQZ0)  
    cholesterol (UNII: 97C5T2UQ7J)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    ceramide 2 (UNII: C04977SRJ5)  
    decyl glucoside (UNII: Z17H97EA6Y)  
    linolenic acid (UNII: 0RBV727H71)  
    peg-10 rapeseed sterol (UNII: 258O76T85M)  
    palmitoyl oligopeptide (UNII: HO4ZT5S86C)  
    ferric oxide red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-248-021 in 1 BOX
    1NDC:13537-248-0130 mL in 1 BOTTLE, PLASTIC
    2NDC:13537-248-041 in 1 BOX
    2NDC:13537-248-0327 mL in 1 BOTTLE, PLASTIC
    3NDC:13537-248-061 in 1 BOX
    3NDC:13537-248-054.5 mL in 1 BOTTLE, PLASTIC
    4NDC:13537-248-081 in 1 BOX
    4NDC:13537-248-073 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (OBSCURE 9) - BROWN
    octinoxate and titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-249
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    xylitylglucoside (UNII: O0IEZ166FB)  
    octyldodecanol (UNII: 461N1O614Y)  
    oleth-5 (UNII: 1GH33785AY)  
    anhydroxylitol (UNII: 8XWR7NN42F)  
    glycerin (UNII: PDC6A3C0OX)  
    linoleic acid (UNII: 9KJL21T0QJ)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
    xylitol (UNII: VCQ006KQ1E)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    aluminum oxide (UNII: LMI26O6933)  
    petrolatum (UNII: 4T6H12BN9U)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    ribes nigrum seed oil (UNII: GKE1188837)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    carnauba wax (UNII: R12CBM0EIZ)  
    tribehenin (UNII: 8OC9U7TQZ0)  
    cholesterol (UNII: 97C5T2UQ7J)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    ceramide 2 (UNII: C04977SRJ5)  
    decyl glucoside (UNII: Z17H97EA6Y)  
    linolenic acid (UNII: 0RBV727H71)  
    peg-10 rapeseed sterol (UNII: 258O76T85M)  
    palmitoyl oligopeptide (UNII: HO4ZT5S86C)  
    ferric oxide red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-249-021 in 1 BOX
    1NDC:13537-249-0130 mL in 1 BOTTLE, PLASTIC
    2NDC:13537-249-041 in 1 BOX
    2NDC:13537-249-0327 mL in 1 BOTTLE, PLASTIC
    3NDC:13537-249-061 in 1 BOX
    3NDC:13537-249-054.5 mL in 1 BOTTLE, PLASTIC
    4NDC:13537-249-081 in 1 BOX
    4NDC:13537-249-073 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (MEDIUM 6A) - BROWN
    octinoxate and titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-299
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    xylitylglucoside (UNII: O0IEZ166FB)  
    octyldodecanol (UNII: 461N1O614Y)  
    oleth-5 (UNII: 1GH33785AY)  
    anhydroxylitol (UNII: 8XWR7NN42F)  
    glycerin (UNII: PDC6A3C0OX)  
    linoleic acid (UNII: 9KJL21T0QJ)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
    xylitol (UNII: VCQ006KQ1E)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    aluminum oxide (UNII: LMI26O6933)  
    petrolatum (UNII: 4T6H12BN9U)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    ribes nigrum seed oil (UNII: GKE1188837)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    carnauba wax (UNII: R12CBM0EIZ)  
    tribehenin (UNII: 8OC9U7TQZ0)  
    cholesterol (UNII: 97C5T2UQ7J)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    ceramide 2 (UNII: C04977SRJ5)  
    decyl glucoside (UNII: Z17H97EA6Y)  
    linolenic acid (UNII: 0RBV727H71)  
    peg-10 rapeseed sterol (UNII: 258O76T85M)  
    palmitoyl oligopeptide (UNII: HO4ZT5S86C)  
    ferric oxide red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-299-021 in 1 BOX
    1NDC:13537-299-0130 mL in 1 BOTTLE, PLASTIC
    2NDC:13537-299-041 in 1 BOX
    2NDC:13537-299-0327 mL in 1 BOTTLE, PLASTIC
    3NDC:13537-299-061 in 1 BOX
    3NDC:13537-299-054.5 mL in 1 BOTTLE, PLASTIC
    4NDC:13537-299-081 in 1 BOX
    4NDC:13537-299-073 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (MEDIUM 6B) - BROWN
    octinoxate and titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-251
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    xylitylglucoside (UNII: O0IEZ166FB)  
    octyldodecanol (UNII: 461N1O614Y)  
    oleth-5 (UNII: 1GH33785AY)  
    anhydroxylitol (UNII: 8XWR7NN42F)  
    glycerin (UNII: PDC6A3C0OX)  
    linoleic acid (UNII: 9KJL21T0QJ)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
    xylitol (UNII: VCQ006KQ1E)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    aluminum oxide (UNII: LMI26O6933)  
    petrolatum (UNII: 4T6H12BN9U)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    ribes nigrum seed oil (UNII: GKE1188837)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    carnauba wax (UNII: R12CBM0EIZ)  
    tribehenin (UNII: 8OC9U7TQZ0)  
    cholesterol (UNII: 97C5T2UQ7J)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    ceramide 2 (UNII: C04977SRJ5)  
    decyl glucoside (UNII: Z17H97EA6Y)  
    linolenic acid (UNII: 0RBV727H71)  
    peg-10 rapeseed sterol (UNII: 258O76T85M)  
    palmitoyl oligopeptide (UNII: HO4ZT5S86C)  
    ferric oxide red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-251-021 in 1 BOX
    1NDC:13537-251-0130 mL in 1 BOTTLE, PLASTIC
    2NDC:13537-251-041 in 1 BOX
    2NDC:13537-251-0327 mL in 1 BOTTLE, PLASTIC
    3NDC:13537-251-061 in 1 BOX
    3NDC:13537-251-054.5 mL in 1 BOTTLE, PLASTIC
    4NDC:13537-251-081 in 1 BOX
    4NDC:13537-251-073 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (OBSCURE 8A) - BROWN
    octinoxate and titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-252
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    xylitylglucoside (UNII: O0IEZ166FB)  
    octyldodecanol (UNII: 461N1O614Y)  
    oleth-5 (UNII: 1GH33785AY)  
    anhydroxylitol (UNII: 8XWR7NN42F)  
    glycerin (UNII: PDC6A3C0OX)  
    linoleic acid (UNII: 9KJL21T0QJ)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
    xylitol (UNII: VCQ006KQ1E)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    aluminum oxide (UNII: LMI26O6933)  
    petrolatum (UNII: 4T6H12BN9U)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    ribes nigrum seed oil (UNII: GKE1188837)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    carnauba wax (UNII: R12CBM0EIZ)  
    tribehenin (UNII: 8OC9U7TQZ0)  
    cholesterol (UNII: 97C5T2UQ7J)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    ceramide 2 (UNII: C04977SRJ5)  
    decyl glucoside (UNII: Z17H97EA6Y)  
    linolenic acid (UNII: 0RBV727H71)  
    peg-10 rapeseed sterol (UNII: 258O76T85M)  
    palmitoyl oligopeptide (UNII: HO4ZT5S86C)  
    ferric oxide red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-252-021 in 1 BOX
    1NDC:13537-252-0130 mL in 1 BOTTLE, PLASTIC
    2NDC:13537-252-041 in 1 BOX
    2NDC:13537-252-0327 mL in 1 BOTTLE, PLASTIC
    3NDC:13537-252-061 in 1 BOX
    3NDC:13537-252-054.5 mL in 1 BOTTLE, PLASTIC
    4NDC:13537-252-081 in 1 BOX
    4NDC:13537-252-073 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (OBSCURE 8B) - BROWN
    octinoxate and titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-253
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    xylitylglucoside (UNII: O0IEZ166FB)  
    octyldodecanol (UNII: 461N1O614Y)  
    oleth-5 (UNII: 1GH33785AY)  
    anhydroxylitol (UNII: 8XWR7NN42F)  
    glycerin (UNII: PDC6A3C0OX)  
    linoleic acid (UNII: 9KJL21T0QJ)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
    xylitol (UNII: VCQ006KQ1E)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    aluminum oxide (UNII: LMI26O6933)  
    petrolatum (UNII: 4T6H12BN9U)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    ribes nigrum seed oil (UNII: GKE1188837)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    carnauba wax (UNII: R12CBM0EIZ)  
    tribehenin (UNII: 8OC9U7TQZ0)  
    cholesterol (UNII: 97C5T2UQ7J)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    ceramide 2 (UNII: C04977SRJ5)  
    decyl glucoside (UNII: Z17H97EA6Y)  
    linolenic acid (UNII: 0RBV727H71)  
    peg-10 rapeseed sterol (UNII: 258O76T85M)  
    palmitoyl oligopeptide (UNII: HO4ZT5S86C)  
    ferric oxide red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-253-021 in 1 BOX
    1NDC:13537-253-0130 mL in 1 BOTTLE, PLASTIC
    2NDC:13537-253-041 in 1 BOX
    2NDC:13537-253-0327 mL in 1 BOTTLE, PLASTIC
    3NDC:13537-253-061 in 1 BOX
    3NDC:13537-253-054.5 mL in 1 BOTTLE, PLASTIC
    4NDC:13537-253-081 in 1 BOX
    4NDC:13537-253-073 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (OBSCURE 8C) - BROWN
    octinoxate and titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-254
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    xylitylglucoside (UNII: O0IEZ166FB)  
    octyldodecanol (UNII: 461N1O614Y)  
    oleth-5 (UNII: 1GH33785AY)  
    anhydroxylitol (UNII: 8XWR7NN42F)  
    glycerin (UNII: PDC6A3C0OX)  
    linoleic acid (UNII: 9KJL21T0QJ)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
    xylitol (UNII: VCQ006KQ1E)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    aluminum oxide (UNII: LMI26O6933)  
    petrolatum (UNII: 4T6H12BN9U)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    ribes nigrum seed oil (UNII: GKE1188837)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    carnauba wax (UNII: R12CBM0EIZ)  
    tribehenin (UNII: 8OC9U7TQZ0)  
    cholesterol (UNII: 97C5T2UQ7J)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    ceramide 2 (UNII: C04977SRJ5)  
    decyl glucoside (UNII: Z17H97EA6Y)  
    linolenic acid (UNII: 0RBV727H71)  
    peg-10 rapeseed sterol (UNII: 258O76T85M)  
    palmitoyl oligopeptide (UNII: HO4ZT5S86C)  
    ferric oxide red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-254-021 in 1 BOX
    1NDC:13537-254-0130 mL in 1 BOTTLE, PLASTIC
    2NDC:13537-254-041 in 1 BOX
    2NDC:13537-254-0327 mL in 1 BOTTLE, PLASTIC
    3NDC:13537-254-061 in 1 BOX
    3NDC:13537-254-054.5 mL in 1 BOTTLE, PLASTIC
    4NDC:13537-254-081 in 1 BOX
    4NDC:13537-254-073 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (OBSCURE 10) - BROWN
    octinoxate and titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-255
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    xylitylglucoside (UNII: O0IEZ166FB)  
    octyldodecanol (UNII: 461N1O614Y)  
    oleth-5 (UNII: 1GH33785AY)  
    anhydroxylitol (UNII: 8XWR7NN42F)  
    glycerin (UNII: PDC6A3C0OX)  
    linoleic acid (UNII: 9KJL21T0QJ)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
    xylitol (UNII: VCQ006KQ1E)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    aluminum oxide (UNII: LMI26O6933)  
    petrolatum (UNII: 4T6H12BN9U)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    ribes nigrum seed oil (UNII: GKE1188837)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    carnauba wax (UNII: R12CBM0EIZ)  
    tribehenin (UNII: 8OC9U7TQZ0)  
    cholesterol (UNII: 97C5T2UQ7J)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    ceramide 2 (UNII: C04977SRJ5)  
    decyl glucoside (UNII: Z17H97EA6Y)  
    linolenic acid (UNII: 0RBV727H71)  
    peg-10 rapeseed sterol (UNII: 258O76T85M)  
    palmitoyl oligopeptide (UNII: HO4ZT5S86C)  
    ferric oxide red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-255-021 in 1 BOX
    1NDC:13537-255-0130 mL in 1 BOTTLE, PLASTIC
    2NDC:13537-255-041 in 1 BOX
    2NDC:13537-255-0327 mL in 1 BOTTLE, PLASTIC
    3NDC:13537-255-061 in 1 BOX
    3NDC:13537-255-054.5 mL in 1 BOTTLE, PLASTIC
    4NDC:13537-255-081 in 1 BOX
    4NDC:13537-255-073 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (DORE 6) - BEIGE
    octinoxate and titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-256
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 g  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.016 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    xylitylglucoside (UNII: O0IEZ166FB)  
    octyldodecanol (UNII: 461N1O614Y)  
    oleth-5 (UNII: 1GH33785AY)  
    anhydroxylitol (UNII: 8XWR7NN42F)  
    glycerin (UNII: PDC6A3C0OX)  
    linoleic acid (UNII: 9KJL21T0QJ)  
    peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
    xylitol (UNII: VCQ006KQ1E)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    aluminum oxide (UNII: LMI26O6933)  
    petrolatum (UNII: 4T6H12BN9U)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    ribes nigrum seed oil (UNII: GKE1188837)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    carnauba wax (UNII: R12CBM0EIZ)  
    tribehenin (UNII: 8OC9U7TQZ0)  
    cholesterol (UNII: 97C5T2UQ7J)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)  
    candelilla wax (UNII: WL0328HX19)  
    yellow wax (UNII: 2ZA36H0S2V)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
    ceramide 2 (UNII: C04977SRJ5)  
    decyl glucoside (UNII: Z17H97EA6Y)  
    linolenic acid (UNII: 0RBV727H71)  
    peg-10 rapeseed sterol (UNII: 258O76T85M)  
    palmitoyl oligopeptide (UNII: HO4ZT5S86C)  
    ferric oxide red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-256-021 in 1 BOX
    1NDC:13537-256-0130 mL in 1 BOTTLE, PLASTIC
    2NDC:13537-256-041 in 1 BOX
    2NDC:13537-256-0327 mL in 1 BOTTLE, PLASTIC
    3NDC:13537-256-061 in 1 BOX
    3NDC:13537-256-054.5 mL in 1 BOTTLE, PLASTIC
    4NDC:13537-256-081 in 1 BOX
    4NDC:13537-256-073 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/16/2013
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-241, 13537-242, 13537-243, 13537-244, 13537-245, 13537-246, 13537-247, 13537-248, 13537-249, 13537-299, 13537-251, 13537-252, 13537-253, 13537-254, 13537-255, 13537-256)