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

----------

L'BEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25

Drug Facts

Active IngredientsPurpose
Octinoxate 6.5 %Sunscreen
Titanium Dioxide 1.6%Sunscreen

Uses

  • Helps prevent sunburn

Warnings

  • Skin Cancer / Skin Aging Alert:Spending time in the sun increases your risk of skin cancer and early skin aging.This product has been shown only to help prevent sunburn, notskin cancer or early skin aging.

  • For external use only.

  • Do not useon damaged or broken skin.

  • When using this productkeep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor ifrash occurs

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months of age: Ask a doctor

Other information

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

Inactive ingredients

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

May contain

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

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 BOX12/16/201312/31/2021
1NDC:14783-241-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:14783-241-041 in 1 BOX12/16/201312/31/2021
2NDC:14783-241-0327 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:14783-241-061 in 1 BOX12/16/201312/31/2021
3NDC:14783-241-054.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:14783-241-081 in 1 BOX12/16/201312/31/2021
4NDC:14783-241-073 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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
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)  
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)  
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-242-021 in 1 BOX12/16/201312/31/2021
1NDC:14783-242-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:14783-242-041 in 1 BOX12/16/201312/31/2021
2NDC:14783-242-0327 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:14783-242-061 in 1 BOX12/16/201312/31/2021
3NDC:14783-242-054.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:14783-242-081 in 1 BOX12/16/201312/31/2021
4NDC:14783-242-073 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:14783-243-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:14783-243-041 in 1 BOX12/16/201312/31/2021
2NDC:14783-243-0327 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:14783-243-061 in 1 BOX12/16/201312/31/2021
3NDC:14783-243-054.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:14783-243-081 in 1 BOX12/16/201312/31/2021
4NDC:14783-243-073 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:14783-244-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:14783-244-041 in 1 BOX12/16/201312/31/2021
2NDC:14783-244-0327 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:14783-244-061 in 1 BOX12/16/201312/31/2021
3NDC:14783-244-054.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:14783-244-081 in 1 BOX12/16/201312/31/2021
4NDC:14783-244-073 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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
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)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-245-021 in 1 BOX12/16/201312/31/2021
1NDC:14783-245-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:14783-245-041 in 1 BOX12/16/201312/31/2021
2NDC:14783-245-0327 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:14783-245-061 in 1 BOX12/16/201312/31/2021
3NDC:14783-245-054.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:14783-245-081 in 1 BOX12/16/201312/31/2021
4NDC:14783-245-073 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:14783-246-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:14783-246-041 in 1 BOX12/16/201312/31/2021
2NDC:14783-246-0327 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:14783-246-061 in 1 BOX12/16/201312/31/2021
3NDC:14783-246-054.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:14783-246-081 in 1 BOX12/16/201312/31/2021
4NDC:14783-246-073 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:14783-247-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:14783-247-041 in 1 BOX12/16/201312/31/2021
2NDC:14783-247-0327 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:14783-247-061 in 1 BOX12/16/201312/31/2021
3NDC:14783-247-054.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:14783-247-081 in 1 BOX12/16/201312/31/2021
4NDC:14783-247-073 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:14783-248-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:14783-248-041 in 1 BOX12/16/201312/31/2021
2NDC:14783-248-0327 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:14783-248-061 in 1 BOX12/16/201312/31/2021
3NDC:14783-248-054.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:14783-248-081 in 1 BOX12/16/201312/31/2021
4NDC:14783-248-073 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:14783-249-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:14783-249-041 in 1 BOX12/16/201312/31/2021
2NDC:14783-249-0327 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:14783-249-061 in 1 BOX12/16/201312/31/2021
3NDC:14783-249-054.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:14783-249-081 in 1 BOX12/16/201312/31/2021
4NDC:14783-249-073 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:14783-250-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:14783-250-041 in 1 BOX12/16/201312/31/2021
2NDC:14783-250-0327 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:14783-250-061 in 1 BOX12/16/201312/31/2021
3NDC:14783-250-054.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:14783-250-081 in 1 BOX12/16/201312/31/2021
4NDC:14783-250-073 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:14783-251-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:14783-251-041 in 1 BOX12/16/201312/31/2021
2NDC:14783-251-0327 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:14783-251-061 in 1 BOX12/16/201312/31/2021
3NDC:14783-251-054.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:14783-251-081 in 1 BOX12/16/201312/31/2021
4NDC:14783-251-073 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:14783-252-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:14783-252-041 in 1 BOX12/16/201312/31/2021
2NDC:14783-252-0327 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:14783-252-061 in 1 BOX12/16/201312/31/2021
3NDC:14783-252-054.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:14783-252-081 in 1 BOX12/16/201312/31/2021
4NDC:14783-252-073 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:14783-253-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:14783-253-041 in 1 BOX12/16/201312/31/2021
2NDC:14783-253-0327 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:14783-253-061 in 1 BOX12/16/201312/31/2021
3NDC:14783-253-054.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:14783-253-081 in 1 BOX12/16/201312/31/2021
4NDC:14783-253-073 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:14783-254-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:14783-254-041 in 1 BOX12/16/201312/31/2021
2NDC:14783-254-0327 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:14783-254-061 in 1 BOX12/16/201312/31/2021
3NDC:14783-254-054.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:14783-254-081 in 1 BOX12/16/201312/31/2021
4NDC:14783-254-073 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:14783-255-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:14783-255-041 in 1 BOX12/16/201312/31/2021
2NDC:14783-255-0327 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:14783-255-061 in 1 BOX12/16/201312/31/2021
3NDC:14783-255-054.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:14783-255-081 in 1 BOX12/16/201312/31/2021
4NDC:14783-255-073 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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 BOX12/16/201312/31/2021
1NDC:14783-256-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:14783-256-041 in 1 BOX12/16/201312/31/2021
2NDC:14783-256-0327 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:14783-256-061 in 1 BOX12/16/201312/31/2021
3NDC:14783-256-054.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:14783-256-081 in 1 BOX12/16/201312/31/2021
4NDC:14783-256-073 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201312/31/2021
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: 2/2025
 
Ventura International LTD