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 .......nium 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
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Contains inactivated NDC Code(s)
NDC Code(s): 14783-241-01, 14783-241-02, 14783-241-03, 14783-241-04, view more14783-241-05, 14783-241-06, 14783-241-07, 14783-241-08, 14783-242-01, 14783-242-02, 14783-242-03, 14783-242-04, 14783-242-05, 14783-242-06, 14783-242-07, 14783-242-08, 14783-243-01, 14783-243-02, 14783-243-03, 14783-243-04, 14783-243-05, 14783-243-06, 14783-243-07, 14783-243-08, 14783-244-01, 14783-244-02, 14783-244-03, 14783-244-04, 14783-244-05, 14783-244-06, 14783-244-07, 14783-244-08, 14783-245-01, 14783-245-02, 14783-245-03, 14783-245-04, 14783-245-05, 14783-245-06, 14783-245-07, 14783-245-08, 14783-246-01, 14783-246-02, 14783-246-03, 14783-246-04, 14783-246-05, 14783-246-06, 14783-246-07, 14783-246-08, 14783-247-01, 14783-247-02, 14783-247-03, 14783-247-04, 14783-247-05, 14783-247-06, 14783-247-07, 14783-247-08, 14783-248-01, 14783-248-02, 14783-248-03, 14783-248-04, 14783-248-05, 14783-248-06, 14783-248-07, 14783-248-08, 14783-249-01, 14783-249-02, 14783-249-03, 14783-249-04, 14783-249-05, 14783-249-06, 14783-249-07, 14783-249-08, 14783-250-01, 14783-250-02, 14783-250-03, 14783-250-04, 14783-250-05, 14783-250-06, 14783-250-07, 14783-250-08, 14783-251-01, 14783-251-02, 14783-251-03, 14783-251-04, 14783-251-05, 14783-251-06, 14783-251-07, 14783-251-08, 14783-252-01, 14783-252-02, 14783-252-03, 14783-252-04, 14783-252-05, 14783-252-06, 14783-252-07, 14783-252-08, 14783-253-01, 14783-253-02, 14783-253-03, 14783-253-04, 14783-253-05, 14783-253-06, 14783-253-07, 14783-253-08, 14783-254-01, 14783-254-02, 14783-254-03, 14783-254-04, 14783-254-05, 14783-254-06, 14783-254-07, 14783-254-08, 14783-255-01, 14783-255-02, 14783-255-03, 14783-255-04, 14783-255-05, 14783-255-06, 14783-255-07, 14783-255-08, 14783-256-01, 14783-256-02, 14783-256-03, 14783-256-04, 14783-256-05, 14783-256-06, 14783-256-07, 14783-256-08 - 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, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
-
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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Claire 1) Beige
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Claire 2) Beige
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Claire 3) Beige
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Claire 4) Beige
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Medium 5) Brown
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Medium 6) Brown
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Medium 7) Brown
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Obscure 8) Brown
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Obscure 9) Brown
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Medium 6A) Brown
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Medium 6B) Brown
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Obscure 8A) Brown
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Obscure 8B) Brown
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Obscure 8C) Brown
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Obscure 10) Brown
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Dore 6) Beige
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INGREDIENTS AND APPEARANCE
LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 Â (CLAIRE 1) - BEIGE
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-241 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.065 g  in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.016 g  in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-241-02 1 in 1 BOX 1 NDC:14783-241-01 30 mL in 1 BOTTLE, PLASTIC 2 NDC:14783-241-04 1 in 1 BOX 2 NDC:14783-241-03 27 mL in 1 BOTTLE, PLASTIC 3 NDC:14783-241-06 1 in 1 BOX 3 NDC:14783-241-05 4.5 mL in 1 BOTTLE, PLASTIC 4 NDC:14783-241-08 1 in 1 BOX 4 NDC:14783-241-07 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2013 LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (CLAIRE 2) - BEIGE
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-242 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.065 g  in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.016 g  in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-242-02 1 in 1 BOX 1 NDC:14783-242-01 30 mL in 1 BOTTLE, PLASTIC 2 NDC:14783-242-04 1 in 1 BOX 2 NDC:14783-242-03 27 mL in 1 BOTTLE, PLASTIC 3 NDC:14783-242-06 1 in 1 BOX 3 NDC:14783-242-05 4.5 mL in 1 BOTTLE, PLASTIC 4 NDC:14783-242-08 1 in 1 BOX 4 NDC:14783-242-07 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2013 LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (CLAIRE 3) - BEIGE
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-243 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.065 g  in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.016 g  in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-243-02 1 in 1 BOX 1 NDC:14783-243-01 30 mL in 1 BOTTLE, PLASTIC 2 NDC:14783-243-04 1 in 1 BOX 2 NDC:14783-243-03 27 mL in 1 BOTTLE, PLASTIC 3 NDC:14783-243-06 1 in 1 BOX 3 NDC:14783-243-05 4.5 mL in 1 BOTTLE, PLASTIC 4 NDC:14783-243-08 1 in 1 BOX 4 NDC:14783-243-07 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2013 LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (CLAIRE 4) - BEIGE
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-244 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.065 g  in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.016 g  in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-244-02 1 in 1 BOX 1 NDC:14783-244-01 30 mL in 1 BOTTLE, PLASTIC 2 NDC:14783-244-04 1 in 1 BOX 2 NDC:14783-244-03 27 mL in 1 BOTTLE, PLASTIC 3 NDC:14783-244-06 1 in 1 BOX 3 NDC:14783-244-05 4.5 mL in 1 BOTTLE, PLASTIC 4 NDC:14783-244-08 1 in 1 BOX 4 NDC:14783-244-07 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2013 LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (MEDIUM 5) - BROWN
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-245 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.065 g  in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.016 g  in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-245-02 1 in 1 BOX 1 NDC:14783-245-01 30 mL in 1 BOTTLE, PLASTIC 2 NDC:14783-245-04 1 in 1 BOX 2 NDC:14783-245-03 27 mL in 1 BOTTLE, PLASTIC 3 NDC:14783-245-06 1 in 1 BOX 3 NDC:14783-245-05 4.5 mL in 1 BOTTLE, PLASTIC 4 NDC:14783-245-08 1 in 1 BOX 4 NDC:14783-245-07 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2013 LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (MEDIUM 6) - BROWN
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-246 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.065 g  in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.016 g  in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-246-02 1 in 1 BOX 1 NDC:14783-246-01 30 mL in 1 BOTTLE, PLASTIC 2 NDC:14783-246-04 1 in 1 BOX 2 NDC:14783-246-03 27 mL in 1 BOTTLE, PLASTIC 3 NDC:14783-246-06 1 in 1 BOX 3 NDC:14783-246-05 4.5 mL in 1 BOTTLE, PLASTIC 4 NDC:14783-246-08 1 in 1 BOX 4 NDC:14783-246-07 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2013 LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (MEDIUM 7) - BROWN
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-247 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.065 g  in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.016 g  in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-247-02 1 in 1 BOX 1 NDC:14783-247-01 30 mL in 1 BOTTLE, PLASTIC 2 NDC:14783-247-04 1 in 1 BOX 2 NDC:14783-247-03 27 mL in 1 BOTTLE, PLASTIC 3 NDC:14783-247-06 1 in 1 BOX 3 NDC:14783-247-05 4.5 mL in 1 BOTTLE, PLASTIC 4 NDC:14783-247-08 1 in 1 BOX 4 NDC:14783-247-07 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2013 LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (OBSCURE 8) - BROWN
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-248 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.065 g  in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.016 g  in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-248-02 1 in 1 BOX 1 NDC:14783-248-01 30 mL in 1 BOTTLE, PLASTIC 2 NDC:14783-248-04 1 in 1 BOX 2 NDC:14783-248-03 27 mL in 1 BOTTLE, PLASTIC 3 NDC:14783-248-06 1 in 1 BOX 3 NDC:14783-248-05 4.5 mL in 1 BOTTLE, PLASTIC 4 NDC:14783-248-08 1 in 1 BOX 4 NDC:14783-248-07 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2013 LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (OBSCURE 9) - BROWN
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-249 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.065 g  in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.016 g  in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-249-02 1 in 1 BOX 1 NDC:14783-249-01 30 mL in 1 BOTTLE, PLASTIC 2 NDC:14783-249-04 1 in 1 BOX 2 NDC:14783-249-03 27 mL in 1 BOTTLE, PLASTIC 3 NDC:14783-249-06 1 in 1 BOX 3 NDC:14783-249-05 4.5 mL in 1 BOTTLE, PLASTIC 4 NDC:14783-249-08 1 in 1 BOX 4 NDC:14783-249-07 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2013 LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (MEDIUM 6A) - BROWN
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-250 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.065 g  in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.016 g  in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-250-02 1 in 1 BOX 1 NDC:14783-250-01 30 mL in 1 BOTTLE, PLASTIC 2 NDC:14783-250-04 1 in 1 BOX 2 NDC:14783-250-03 27 mL in 1 BOTTLE, PLASTIC 3 NDC:14783-250-06 1 in 1 BOX 3 NDC:14783-250-05 4.5 mL in 1 BOTTLE, PLASTIC 4 NDC:14783-250-08 1 in 1 BOX 4 NDC:14783-250-07 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2013 LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (MEDIUM 6B) - BROWN
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-251 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.065 g  in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.016 g  in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-251-02 1 in 1 BOX 1 NDC:14783-251-01 30 mL in 1 BOTTLE, PLASTIC 2 NDC:14783-251-04 1 in 1 BOX 2 NDC:14783-251-03 27 mL in 1 BOTTLE, PLASTIC 3 NDC:14783-251-06 1 in 1 BOX 3 NDC:14783-251-05 4.5 mL in 1 BOTTLE, PLASTIC 4 NDC:14783-251-08 1 in 1 BOX 4 NDC:14783-251-07 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2013 LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (OBSCURE 8A) - BROWN
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-252 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.065 g  in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.016 g  in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-252-02 1 in 1 BOX 1 NDC:14783-252-01 30 mL in 1 BOTTLE, PLASTIC 2 NDC:14783-252-04 1 in 1 BOX 2 NDC:14783-252-03 27 mL in 1 BOTTLE, PLASTIC 3 NDC:14783-252-06 1 in 1 BOX 3 NDC:14783-252-05 4.5 mL in 1 BOTTLE, PLASTIC 4 NDC:14783-252-08 1 in 1 BOX 4 NDC:14783-252-07 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2013 LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (OBSCURE 8B) - BROWN
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-253 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.065 g  in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.016 g  in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-253-02 1 in 1 BOX 1 NDC:14783-253-01 30 mL in 1 BOTTLE, PLASTIC 2 NDC:14783-253-04 1 in 1 BOX 2 NDC:14783-253-03 27 mL in 1 BOTTLE, PLASTIC 3 NDC:14783-253-06 1 in 1 BOX 3 NDC:14783-253-05 4.5 mL in 1 BOTTLE, PLASTIC 4 NDC:14783-253-08 1 in 1 BOX 4 NDC:14783-253-07 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2013 LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (OBSCURE 8C) - BROWN
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-254 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.065 g  in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.016 g  in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-254-02 1 in 1 BOX 1 NDC:14783-254-01 30 mL in 1 BOTTLE, PLASTIC 2 NDC:14783-254-04 1 in 1 BOX 2 NDC:14783-254-03 27 mL in 1 BOTTLE, PLASTIC 3 NDC:14783-254-06 1 in 1 BOX 3 NDC:14783-254-05 4.5 mL in 1 BOTTLE, PLASTIC 4 NDC:14783-254-08 1 in 1 BOX 4 NDC:14783-254-07 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2013 LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (OBSCURE 10) - BROWN
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-255 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.065 g  in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.016 g  in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-255-02 1 in 1 BOX 1 NDC:14783-255-01 30 mL in 1 BOTTLE, PLASTIC 2 NDC:14783-255-04 1 in 1 BOX 2 NDC:14783-255-03 27 mL in 1 BOTTLE, PLASTIC 3 NDC:14783-255-06 1 in 1 BOX 3 NDC:14783-255-05 4.5 mL in 1 BOTTLE, PLASTIC 4 NDC:14783-255-08 1 in 1 BOX 4 NDC:14783-255-07 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2013 LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (DORE 6) - BEIGE
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-256 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.065 g  in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.016 g  in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-256-02 1 in 1 BOX 1 NDC:14783-256-01 30 mL in 1 BOTTLE, PLASTIC 2 NDC:14783-256-04 1 in 1 BOX 2 NDC:14783-256-03 27 mL in 1 BOTTLE, PLASTIC 3 NDC:14783-256-06 1 in 1 BOX 3 NDC:14783-256-05 4.5 mL in 1 BOTTLE, PLASTIC 4 NDC:14783-256-08 1 in 1 BOX 4 NDC:14783-256-07 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2013 Labeler - Ventura International LTD (603192787) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(14783-241, 14783-242, 14783-243, 14783-244, 14783-245, 14783-246, 14783-247, 14783-248, 14783-249, 14783-250, 14783-251, 14783-252, 14783-253, 14783-254, 14783-255, 14783-256)