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 MOISTURIZING FOUNDATION SPF 25  (CLAIRE 4) - BEIGE- octinoxate and titanium dioxide liquid 
LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (MEDIUM 5) - BROWN- octinoxate and titanium dioxide liquid 
LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (MEDIUM 6) - BROWN- octinoxate and titanium dioxide liquid 
LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (MEDIUM 7) - BROWN- octinoxate and titanium dioxide liquid 
LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (OBSCURE 8) - BROWN- octinoxate and titanium dioxide liquid 
LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (OBSCURE 9) - BROWN- octinoxate and titanium dioxide liquid 
LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (MEDIUM 6A) - BROWN- octinoxate and titanium dioxide liquid 
LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (MEDIUM 6B) - BROWN- octinoxate and titanium dioxide liquid 
LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (OBSCURE 8A) - BROWN- octinoxate and titanium dioxide liquid 
LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25  (OBSCURE 8B) - BROWN- octinoxate and titanium 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 
Ventura International LTD

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.

----------

L'BEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25

Drug Facts

Active IngredientsPurpose
Octinoxate 6.5 %Sunscreen
Titanium Dioxide 1.6%Sunscreen

Uses

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

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

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

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

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

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

Principal Display Panel - 30 ml Bottle Box (Claire 1) Beige

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Claire 2) Beige

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

Principal Display Panel - 30 ml Bottle Box (Claire 2) Beige

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Claire 3) Beige

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

Principal Display Panel - 30 ml Bottle Box (Claire 3) Beige

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Claire 4) Beige

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

Principal Display Panel - 30 ml Bottle Box (Claire 4) Beige

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Medium 5) Brown

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

Principal Display Panel - 30 ml Bottle Box (Medium 5) Brown

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Medium 6) Brown

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

Principal Display Panel - 30 ml Bottle Box (Medium 6) Brown

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Medium 7) Brown

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

Principal Display Panel - 30 ml Bottle Box (Medium 7) Brown

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Obscure 8) Brown

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

Principal Display Panel - 30 ml Bottle Box (Obscure 8) Brown

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Obscure 9) Brown

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

Principal Display Panel - 30 ml Bottle Box (Obscure 9) Brown

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Medium 6A) Brown

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

Principal Display Panel - 30 ml Bottle Box (Medium 6A) Brown

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Medium 6B) Brown

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

Principal Display Panel - 30 ml Bottle Box (Medium 6B) Brown

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Obscure 8A) Brown

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

Principal Display Panel - 30 ml Bottle Box (Obscure 8A) Brown

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Obscure 8B) Brown

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

Principal Display Panel - 30 ml Bottle Box (Obscure 8B) Brown

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Obscure 8C) Brown

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

Principal Display Panel - 30 ml Bottle Box (Obscure 8C) Brown

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Obscure 10) Brown

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

Principal Display Panel - 30 ml Bottle Box (Obscure 10) Brown

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box (Dore 6) Beige

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

Principal Display Panel - 30 ml Bottle Box (Dore 6) Beige
LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (CLAIRE 1) - BEIGE
octinoxate and titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-241
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:14783-241-021 in 1 BOX
1NDC:14783-241-0130 mL in 1 BOTTLE, PLASTIC
2NDC:14783-241-041 in 1 BOX
2NDC:14783-241-0327 mL in 1 BOTTLE, PLASTIC
3NDC:14783-241-061 in 1 BOX
3NDC:14783-241-054.5 mL in 1 BOTTLE, PLASTIC
4NDC:14783-241-081 in 1 BOX
4NDC:14783-241-073 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:14783-242
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:14783-242-021 in 1 BOX
1NDC:14783-242-0130 mL in 1 BOTTLE, PLASTIC
2NDC:14783-242-041 in 1 BOX
2NDC:14783-242-0327 mL in 1 BOTTLE, PLASTIC
3NDC:14783-242-061 in 1 BOX
3NDC:14783-242-054.5 mL in 1 BOTTLE, PLASTIC
4NDC:14783-242-081 in 1 BOX
4NDC:14783-242-073 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:14783-243
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:14783-243-021 in 1 BOX
1NDC:14783-243-0130 mL in 1 BOTTLE, PLASTIC
2NDC:14783-243-041 in 1 BOX
2NDC:14783-243-0327 mL in 1 BOTTLE, PLASTIC
3NDC:14783-243-061 in 1 BOX
3NDC:14783-243-054.5 mL in 1 BOTTLE, PLASTIC
4NDC:14783-243-081 in 1 BOX
4NDC:14783-243-073 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:14783-244
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:14783-244-021 in 1 BOX
1NDC:14783-244-0130 mL in 1 BOTTLE, PLASTIC
2NDC:14783-244-041 in 1 BOX
2NDC:14783-244-0327 mL in 1 BOTTLE, PLASTIC
3NDC:14783-244-061 in 1 BOX
3NDC:14783-244-054.5 mL in 1 BOTTLE, PLASTIC
4NDC:14783-244-081 in 1 BOX
4NDC:14783-244-073 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:14783-245
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:14783-245-021 in 1 BOX
1NDC:14783-245-0130 mL in 1 BOTTLE, PLASTIC
2NDC:14783-245-041 in 1 BOX
2NDC:14783-245-0327 mL in 1 BOTTLE, PLASTIC
3NDC:14783-245-061 in 1 BOX
3NDC:14783-245-054.5 mL in 1 BOTTLE, PLASTIC
4NDC:14783-245-081 in 1 BOX
4NDC:14783-245-073 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:14783-246
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:14783-246-021 in 1 BOX
1NDC:14783-246-0130 mL in 1 BOTTLE, PLASTIC
2NDC:14783-246-041 in 1 BOX
2NDC:14783-246-0327 mL in 1 BOTTLE, PLASTIC
3NDC:14783-246-061 in 1 BOX
3NDC:14783-246-054.5 mL in 1 BOTTLE, PLASTIC
4NDC:14783-246-081 in 1 BOX
4NDC:14783-246-073 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:14783-247
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:14783-247-021 in 1 BOX
1NDC:14783-247-0130 mL in 1 BOTTLE, PLASTIC
2NDC:14783-247-041 in 1 BOX
2NDC:14783-247-0327 mL in 1 BOTTLE, PLASTIC
3NDC:14783-247-061 in 1 BOX
3NDC:14783-247-054.5 mL in 1 BOTTLE, PLASTIC
4NDC:14783-247-081 in 1 BOX
4NDC:14783-247-073 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:14783-248
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:14783-248-021 in 1 BOX
1NDC:14783-248-0130 mL in 1 BOTTLE, PLASTIC
2NDC:14783-248-041 in 1 BOX
2NDC:14783-248-0327 mL in 1 BOTTLE, PLASTIC
3NDC:14783-248-061 in 1 BOX
3NDC:14783-248-054.5 mL in 1 BOTTLE, PLASTIC
4NDC:14783-248-081 in 1 BOX
4NDC:14783-248-073 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:14783-249
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:14783-249-021 in 1 BOX
1NDC:14783-249-0130 mL in 1 BOTTLE, PLASTIC
2NDC:14783-249-041 in 1 BOX
2NDC:14783-249-0327 mL in 1 BOTTLE, PLASTIC
3NDC:14783-249-061 in 1 BOX
3NDC:14783-249-054.5 mL in 1 BOTTLE, PLASTIC
4NDC:14783-249-081 in 1 BOX
4NDC:14783-249-073 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:14783-250
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:14783-250-021 in 1 BOX
1NDC:14783-250-0130 mL in 1 BOTTLE, PLASTIC
2NDC:14783-250-041 in 1 BOX
2NDC:14783-250-0327 mL in 1 BOTTLE, PLASTIC
3NDC:14783-250-061 in 1 BOX
3NDC:14783-250-054.5 mL in 1 BOTTLE, PLASTIC
4NDC:14783-250-081 in 1 BOX
4NDC:14783-250-073 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:14783-251
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:14783-251-021 in 1 BOX
1NDC:14783-251-0130 mL in 1 BOTTLE, PLASTIC
2NDC:14783-251-041 in 1 BOX
2NDC:14783-251-0327 mL in 1 BOTTLE, PLASTIC
3NDC:14783-251-061 in 1 BOX
3NDC:14783-251-054.5 mL in 1 BOTTLE, PLASTIC
4NDC:14783-251-081 in 1 BOX
4NDC:14783-251-073 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:14783-252
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:14783-252-021 in 1 BOX
1NDC:14783-252-0130 mL in 1 BOTTLE, PLASTIC
2NDC:14783-252-041 in 1 BOX
2NDC:14783-252-0327 mL in 1 BOTTLE, PLASTIC
3NDC:14783-252-061 in 1 BOX
3NDC:14783-252-054.5 mL in 1 BOTTLE, PLASTIC
4NDC:14783-252-081 in 1 BOX
4NDC:14783-252-073 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:14783-253
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:14783-253-021 in 1 BOX
1NDC:14783-253-0130 mL in 1 BOTTLE, PLASTIC
2NDC:14783-253-041 in 1 BOX
2NDC:14783-253-0327 mL in 1 BOTTLE, PLASTIC
3NDC:14783-253-061 in 1 BOX
3NDC:14783-253-054.5 mL in 1 BOTTLE, PLASTIC
4NDC:14783-253-081 in 1 BOX
4NDC:14783-253-073 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:14783-254
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:14783-254-021 in 1 BOX
1NDC:14783-254-0130 mL in 1 BOTTLE, PLASTIC
2NDC:14783-254-041 in 1 BOX
2NDC:14783-254-0327 mL in 1 BOTTLE, PLASTIC
3NDC:14783-254-061 in 1 BOX
3NDC:14783-254-054.5 mL in 1 BOTTLE, PLASTIC
4NDC:14783-254-081 in 1 BOX
4NDC:14783-254-073 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:14783-255
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:14783-255-021 in 1 BOX
1NDC:14783-255-0130 mL in 1 BOTTLE, PLASTIC
2NDC:14783-255-041 in 1 BOX
2NDC:14783-255-0327 mL in 1 BOTTLE, PLASTIC
3NDC:14783-255-061 in 1 BOX
3NDC:14783-255-054.5 mL in 1 BOTTLE, PLASTIC
4NDC:14783-255-081 in 1 BOX
4NDC:14783-255-073 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:14783-256
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:14783-256-021 in 1 BOX
1NDC:14783-256-0130 mL in 1 BOTTLE, PLASTIC
2NDC:14783-256-041 in 1 BOX
2NDC:14783-256-0327 mL in 1 BOTTLE, PLASTIC
3NDC:14783-256-061 in 1 BOX
3NDC:14783-256-054.5 mL in 1 BOTTLE, PLASTIC
4NDC:14783-256-081 in 1 BOX
4NDC:14783-256-073 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/16/2013
Labeler - Ventura International LTD (603192787)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE(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)

Revised: 12/2013
Document Id: df1a63be-d4c1-49a0-978e-c1744c051eb8
Set id: 911dafb8-fdde-42cc-996f-0a9734a7e40d
Version: 1
Effective Time: 20131220
 
Ventura International LTD