TOTY ILUMINA CC CREAMY COMPACT 2W- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT 3W- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT 3C- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT 6N- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT 5W1- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT 1C- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT 2C- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT 4N- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT 4W- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT 3N- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT 2N- titanium dioxide cream

toty Ilumina CC Creamy Compact 2N by

Drug Labeling and Warnings

toty Ilumina CC Creamy Compact 2N by is a Otc medication manufactured, distributed, or labeled by Chipican LLC, Industrial Farmaceutica Cantabria SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Titanium Dioxide- 10.4%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

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

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

DOSAGE & ADMINISTRATION

• Apply liberally 15 minutes behore sun exposure
• Reapply:

After 80 minutes of swimming or sweating

​ Immediately after towel drying

At least every 2 hours

• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10 a.m. - 2 p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months of age: Ask a doctor.

Other Information

• Do not expose the sudden changes in temperature or extreme temperatures

• Protect the product from direct sunlight

• Store below 30°C/86°F

Inactive Ingredients

NDCs 82141-2344-1 & 82141-2347-1

Hydrogenated Polyisobutene; Ethylhexyl Palmitate; Nylon-12; Paraffin; Mica, Hydrogenated Microcrystalline Wax; Polymethyl Methacrylate; Butylene Glycol Cocoate; Methyl Methacrylate Crosspolymer; Carnauba ( Copernica cerifera) Wax; Silica; Hydrogenated Castor Oil; Alumina, Squalene, Calaguala ( Polypodium leucotomos) Leaf Extract; Propylene Glycol; Glyceryl Caprylate; Tocopheryl Acetate; Castor ( Ricinus communis) Seed Oil; Water; Simethicone; Tocopherol; Beta-Sitosterol; Soybean ( Glycine soja) Oil; Paraffinum Liquidum; Fragrance, Linalool, Iron Oxides* (Ferric Oxide Red (CI 77491), Ferric Oxide Yellow (CI 77492), Ferrosoferric Oxide (CI 77499)); Titanium Dioxide* (CI 77891), Bismuth Oxychloride* (CI 77163). * Contains one or more of these ingredients.

NDCs 82141-2345-1 & 82141-2348-1

Hydrogenated Polyisobutene; Ethylhexyl Palmitate; Nylon-12; Paraffin; Hydrogenated Microcrystalline Wax; Polymethyl Methacrylate; Mica; Butylene Glycol Cocoate; Methyl Methacrylate Crosspolymer; Carnauba ( Copernica cerifera) Wax; Silica; Hydrogenated Castor Oil; Alumina, Squalene, Calaguala ( Polypodium leucotomos) Leaf Extract; Propylene Glycol; Glyceryl Caprylate; Tocopheryl Acetate; Castor ( Ricinus communis) Seed Oil; Water; Simethicone; Tocopherol; Beta-Sitosterol; Soybean ( Glycine soja) Oil; Paraffinum Liquidum; Fragrance, Linalool, Iron Oxides* (Ferric Oxide Red (CI 77491), Ferric Oxide Yellow (CI 77492), Ferrosoferric Oxide (CI 77499)); Titanium Dioxide* (CI 77891), Bismuth Oxychloride* (CI 77163). * Contains one or more of these ingredients.

NDCs 82141-2346-1 & 82141-2350-1

Hydrogenated Polyisobutene; Ethylhexyl Palmitate; Nylon-12; Paraffin; Hydrogenated Microcrystalline Wax; Polymethyl Methacrylate; Butylene Glycol Cocoate; Mica; Methyl Methacrylate Crosspolymer; Carnauba ( Copernica cerifera) Wax; Silica; Hydrogenated Castor Oil; Alumina, Squalene, Calaguala ( Polypodium leucotomos) Leaf Extract; Propylene Glycol; Glyceryl Caprylate; Tocopheryl Acetate; Castor ( Ricinus communis) Seed Oil; Water; Simethicone; Tocopherol; Beta-Sitosterol; Soybean ( Glycine soja) Oil; Paraffinum Liquidum; Fragrance, Linalool, Iron Oxides* (Ferric Oxide Red (CI 77491), Ferric Oxide Yellow (CI 77492), Ferrosoferric Oxide (CI 77499)); Titanium Dioxide* (CI 77891), Bismuth Oxychloride* (CI 77163). * Contains one or more of these ingredients.

NDC: 82141-2349-1

Hydrogenated Polyisobutene; Ethylhexyl Palmitate; Nylon-12; Paraffin; Hydrogenated Microcrystalline Wax; Mica; Polymethyl Methacrylate; Butylene Glycol Cocoate; Methyl Methacrylate Crosspolymer; Carnauba ( Copernica cerifera) Wax; Silica;
Hydrogenated Castor Oil; Alumina, Squalene, Calaguala ( Polypodium leucotomos) Leaf Extract; Propylene Glycol; Glyceryl Caprylate; Tocopheryl Acetate; Castor ( Ricinus communis) Seed Oil; Water; Simethicone; Tocopherol; Beta-Sitosterol; Soybean ( Glycine soja) Oil; Triethoxycaprylylsilane; Paraffinum Liquidum; Fragrance, Linalool, Iron Oxides* (Ferric Oxide Red (CI 77491), Ferric Oxide Yellow (CI 77492), Ferrosoferric Oxide (CI 77499)); Titanium Dioxide* (CI 77891), Bismuth Oxychloride* (CI 77163). * Contains one or more of these ingredients.

NDC: 82141-2351-1

Hydrogenated Polyisobutene; Ethylhexyl Palmitate; Nylon-12; Paraffin; Mica; Polymethyl Methacrylate; Hydrogenated Microcrystalline Wax; Butylene Glycol Cocoate; Methyl Methacrylate Crosspolymer; Carnauba ( Copernica cerifera) Wax; Silica; Hydrogenated Castor Oil; Alumina, Squalene, Calaguala ( Polypodium leucotomos) Leaf Extract; Propylene Glycol; Glyceryl Caprylate; Tocopheryl Acetate; Castor ( Ricinus communis) Seed Oil; Water; Simethicone; Tocopherol; Beta-Sitosterol; Soybean ( Glycine soja) Oil; Paraffinum Liquidum; Fragrance, Linalool, Iron Oxides* (Ferric Oxide Red (CI 77491), Ferric Oxide Yellow (CI 77492), Ferrosoferric Oxide (CI 77499)); Titanium Dioxide* (CI 77891), Bismuth Oxychloride* (CI 77163). * Contains one or more of these ingredients.

NDC: 82141-2352-1

Hydrogenated Polyisobutene; Ethylhexyl Palmitate; Nylon-12; Paraffin; Hydrogenated Microcrystalline Wax; Polymethyl Methacrylate; Mica; Butylene Glycol Cocoate; Methyl Methacrylate Crosspolymer; Carnauba ( Copernica cerifera) Wax; Silica; Hydrogenated Castor Oil; Alumina, Squalene, Calaguala ( Polypodium leucotomos) Leaf Extract; Propylene Glycol; Glyceryl Caprylate; Tocopheryl Acetate; Castor ( Ricinus communis) Seed Oil; Water; Simethicone; Tocopherol; Beta-Sitosterol; Soybean ( Glycine soja) Oil; Triethoxycaprylylsilane; Paraffinum Liquidum; Fragrance, Linalool, Iron Oxides* (Ferric Oxide Red (CI 77491), Ferric Oxide Yellow (CI 77492), Ferrosoferric Oxide (CI 77499)); Titanium Dioxide* (CI 77891), Bismuth Oxychloride* (CI 77163). * Contains one or more of these ingredients.

NDC: 82141-2355-1

Hydrogenated Polyisobutene; Ethylhexyl Palmitate; Nylon-12; Paraffin; Hydrogenated Microcrystalline Wax; Butylene Glycol Cocoate; Mica; Polymethyl Methacrylate; Carnauba ( Copernica cerifera) Wax; Methyl Methacrylate Crosspolymer; Silica; Hydrogenated Castor Oil; Alumina, Squalene, Calaguala ( Polypodium leucotomos) Leaf Extract; Propylene Glycol; Glyceryl Caprylate; Tocopheryl Acetate; Castor ( Ricinus communis) Seed Oil; Water; Simethicone; Tocopherol; Beta-Sitosterol; Soybean ( Glycine soja) Oil; Triethoxycaprylylsilane; Paraffinum Liquidum; Fragrance, Linalool, Iron Oxides* (Ferric Oxide Red (CI 77491), Ferric Oxide Yellow (CI 77492), Ferrosoferric Oxide (CI 77499)); Titanium Dioxide* (CI 77891), Bismuth Oxychloride* (CI 77163). * Contains one or more of these ingredients.

NDC: 82141-0913-1

Hydrogenated Polyisobutene; Ethylhexyl Palmitate; Nylon-12; Paraffin; Hydrogenated Microcrystalline Wax; Butylene Glycol Cocoate; Carnauba ( Copernica cerifera) Wax; Mica; Polymethyl Methacrylate; Hydrogenated Castor Oil; Silica; ; Alumina, Squalene, Calaguala ( Polypodium leucotomos) Leaf Extract; Propylene Glycol; Glyceryl Caprylate; Tocopheryl Acetate; Castor ( Ricinus communis) Seed Oil; Water; Simethicone; Tocopherol; Beta-Sitosterol; Soybean ( Glycine soja) Oil; Sodium Stearate; Cethearyl Alcohol; Ceteareth-20; Calcium Chloride; Triethoxycaprylylsilane; Fragrance, Linalool, Iron Oxides* (Ferric Oxide Red (CI 77491), Ferric Oxide Yellow (CI 77492), Ferrosoferric Oxide (CI 77499)); Bismuth Oxychloride* (CI 77163). * Contains one or more of these ingredients.

toty Ilumina CC Creamy Compact 1C

NDC: 82141-2344-1 (toty Ilumina CC Creamy Compact 1C)

toty. ®

ILUMINA
CC CREAMY COMPACT
SPF 50+
SKIN-PERFECTING BLURRING BALM

BALSAMO PERFECCIONADOR DIFUMINADOR
.....................................................................................

BROAD SPECTRUM SPF 50+ MINERAL SUNSCREEN
WATER RESISTANT (80 MINUTES)

PROTECCION SOLAR MINERAL AMPLIO ESPECTRO SPF 50+
RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

toty Ilumina CC Creamy Compact 2N

NDC: 82141-2345-1 (toty Ilumina CC Creamy Compact 2N)

toty. ®

ILUMINA
CC CREAMY COMPACT
SPF 50+
SKIN-PERFECTING BLURRING BALM

BALSAMO PERFECCIONADOR DIFUMINADOR
.....................................................................................

BROAD SPECTRUM SPF 50+ MINERAL SUNSCREEN
WATER RESISTANT (80 MINUTES)

PROTECCION SOLAR MINERAL AMPLIO ESPECTRO SPF 50+
RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

toty Ilumina CC Creamy Compact 2W

NDC: 82141-2346-1 (toty Ilumina CC Creamy Compact 2W)

toty. ®

ILUMINA
CC CREAMY COMPACT
SPF 50+
SKIN-PERFECTING BLURRING BALM

BALSAMO PERFECCIONADOR DIFUMINADOR
.....................................................................................

BROAD SPECTRUM SPF 50+ MINERAL SUNSCREEN
WATER RESISTANT (80 MINUTES)

PROTECCION SOLAR MINERAL AMPLIO ESPECTRO SPF 50+
RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

toty Ilumina CC Creamy Compact 2C

NDC: 82141-2347-1 (toty Ilumina CC Creamy Compact 2C)

toty. ®

ILUMINA
CC CREAMY COMPACT
SPF 50+
SKIN-PERFECTING BLURRING BALM

BALSAMO PERFECCIONADOR DIFUMINADOR
.....................................................................................

BROAD SPECTRUM SPF 50+ MINERAL SUNSCREEN
WATER RESISTANT (80 MINUTES)

PROTECCION SOLAR MINERAL AMPLIO ESPECTRO SPF 50+
RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

toty Ilumina CC Creamy Compact 3N

NDC: 82141-2348-1 (toty Ilumina CC Creamy Compact 3N)

toty. ®

ILUMINA
CC CREAMY COMPACT
SPF 50+
SKIN-PERFECTING BLURRING BALM

BALSAMO PERFECCIONADOR DIFUMINADOR
.....................................................................................

BROAD SPECTRUM SPF 50+ MINERAL SUNSCREEN
WATER RESISTANT (80 MINUTES)

PROTECCION SOLAR MINERAL AMPLIO ESPECTRO SPF 50+
RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

toty Ilumina CC Creamy Compact 3W

NDC: 82141-2349-1 (toty Ilumina CC Creamy Compact 3W)

toty. ®

ILUMINA
CC CREAMY COMPACT
SPF 50+
SKIN-PERFECTING BLURRING BALM

BALSAMO PERFECCIONADOR DIFUMINADOR
.....................................................................................

BROAD SPECTRUM SPF 50+ MINERAL SUNSCREEN
WATER RESISTANT (80 MINUTES)

PROTECCION SOLAR MINERAL AMPLIO ESPECTRO SPF 50+
RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

toty Ilumina CC Creamy Compact 3C

NDC: 82141-2350-1 (toty Ilumina CC Creamy Compact 3C)

toty. ®

ILUMINA
CC CREAMY COMPACT
SPF 50+
SKIN-PERFECTING BLURRING BALM

BALSAMO PERFECCIONADOR DIFUMINADOR
.....................................................................................

BROAD SPECTRUM SPF 50+ MINERAL SUNSCREEN
WATER RESISTANT (80 MINUTES)

PROTECCION SOLAR MINERAL AMPLIO ESPECTRO SPF 50+
RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

toty Ilumina CC Creamy Compact 4N

NDC: 82141-2351-1 (toty Ilumina CC Creamy Compact 4N)

toty. ®

ILUMINA
CC CREAMY COMPACT
SPF 50+
SKIN-PERFECTING BLURRING BALM

BALSAMO PERFECCIONADOR DIFUMINADOR
.....................................................................................

BROAD SPECTRUM SPF 50+ MINERAL SUNSCREEN
WATER RESISTANT (80 MINUTES)

PROTECCION SOLAR MINERAL AMPLIO ESPECTRO SPF 50+
RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

toty Ilumina CC Creamy Compact 4W

NDC: 82141-2352-1 (toty Ilumina CC Creamy Compact 4W)

toty. ®

ILUMINA
CC CREAMY COMPACT
SPF 50+
SKIN-PERFECTING BLURRING BALM

BALSAMO PERFECCIONADOR DIFUMINADOR
.....................................................................................

BROAD SPECTRUM SPF 50+ MINERAL SUNSCREEN
WATER RESISTANT (80 MINUTES)

PROTECCION SOLAR MINERAL AMPLIO ESPECTRO SPF 50+
RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

toty Ilumina CC Creamy Compact 5W1

NDC: 82141-2355-1 (toty Ilumina CC Creamy Compact 5W1)

toty. ®

ILUMINA
CC CREAMY COMPACT
SPF 50+
SKIN-PERFECTING BLURRING BALM

BALSAMO PERFECCIONADOR DIFUMINADOR
.....................................................................................

BROAD SPECTRUM SPF 50+ MINERAL SUNSCREEN
WATER RESISTANT (80 MINUTES)

PROTECCION SOLAR MINERAL AMPLIO ESPECTRO SPF 50+
RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

toty Ilumina CC Creamy Compact 6N

NDC: 82141-0913-1 (toty Ilumina CC Creamy Compact 6N)

toty. ®

ILUMINA
CC CREAMY COMPACT
SPF 50+
SKIN-PERFECTING BLURRING BALM

BALSAMO PERFECCIONADOR DIFUMINADOR
.....................................................................................

BROAD SPECTRUM SPF 50+ MINERAL SUNSCREEN
WATER RESISTANT (80 MINUTES)

PROTECCION SOLAR MINERAL AMPLIO ESPECTRO SPF 50+
RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

INGREDIENTS AND APPEARANCE

TOTY ILUMINA CC CREAMY COMPACT 2W 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82141-2346
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ALUMINUM OXIDE (UNII: LMI26O6933)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
NYLON-12 (UNII: 446U8J075B)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
MICA (UNII: V8A1AW0880)
SQUALENE (UNII: 7QWM220FJH)
CASTOR OIL (UNII: D5340Y2I9G)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82141-2346-1	1 in 1 CARTON	09/01/2025
1		10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2025

TOTY ILUMINA CC CREAMY COMPACT 3W 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82141-2349
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ALUMINUM OXIDE (UNII: LMI26O6933)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
NYLON-12 (UNII: 446U8J075B)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
MICA (UNII: V8A1AW0880)
SQUALENE (UNII: 7QWM220FJH)
CASTOR OIL (UNII: D5340Y2I9G)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82141-2349-1	1 in 1 CARTON	09/01/2025
1		10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2025

TOTY ILUMINA CC CREAMY COMPACT 3C 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82141-2350
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ALUMINUM OXIDE (UNII: LMI26O6933)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
NYLON-12 (UNII: 446U8J075B)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
MICA (UNII: V8A1AW0880)
SQUALENE (UNII: 7QWM220FJH)
CASTOR OIL (UNII: D5340Y2I9G)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CARNAUBA WAX (UNII: R12CBM0EIZ)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82141-2350-1	1 in 1 CARTON	09/01/2025
1		10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2025

TOTY ILUMINA CC CREAMY COMPACT 6N 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82141-0913
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
SODIUM STEARATE (UNII: QU7E2XA9TG)
CETEARETH-20 (UNII: YRC528SWUY)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
CASTOR OIL (UNII: D5340Y2I9G)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MICA (UNII: V8A1AW0880)
NYLON-12 (UNII: 446U8J075B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
SOYBEAN OIL (UNII: 241ATL177A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PARAFFIN (UNII: I9O0E3H2ZE)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
SQUALENE (UNII: 7QWM220FJH)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ALUMINUM OXIDE (UNII: LMI26O6933)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82141-0913-1	1 in 1 CARTON	09/01/2025
1		10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2025

TOTY ILUMINA CC CREAMY COMPACT 5W1 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82141-2355
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ALUMINUM OXIDE (UNII: LMI26O6933)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
NYLON-12 (UNII: 446U8J075B)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
MICA (UNII: V8A1AW0880)
SQUALENE (UNII: 7QWM220FJH)
CASTOR OIL (UNII: D5340Y2I9G)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82141-2355-1	1 in 1 CARTON	09/01/2025
1		10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2025

TOTY ILUMINA CC CREAMY COMPACT 1C 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82141-2344
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
NYLON-12 (UNII: 446U8J075B)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
MICA (UNII: V8A1AW0880)
SQUALENE (UNII: 7QWM220FJH)
CASTOR OIL (UNII: D5340Y2I9G)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CARNAUBA WAX (UNII: R12CBM0EIZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82141-2344-1	1 in 1 CARTON	09/01/2025
1		10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2025

TOTY ILUMINA CC CREAMY COMPACT 2C 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82141-2347
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ALUMINUM OXIDE (UNII: LMI26O6933)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
NYLON-12 (UNII: 446U8J075B)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
MICA (UNII: V8A1AW0880)
SQUALENE (UNII: 7QWM220FJH)
CASTOR OIL (UNII: D5340Y2I9G)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82141-2347-1	1 in 1 CARTON	09/01/2025
1		10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2025

TOTY ILUMINA CC CREAMY COMPACT 4N 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82141-2351
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ALUMINUM OXIDE (UNII: LMI26O6933)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
NYLON-12 (UNII: 446U8J075B)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
MICA (UNII: V8A1AW0880)
SQUALENE (UNII: 7QWM220FJH)
CASTOR OIL (UNII: D5340Y2I9G)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82141-2351-1	1 in 1 CARTON	09/01/2025
1		10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2025

TOTY ILUMINA CC CREAMY COMPACT 4W 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82141-2352
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ALUMINUM OXIDE (UNII: LMI26O6933)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
NYLON-12 (UNII: 446U8J075B)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
MICA (UNII: V8A1AW0880)
SQUALENE (UNII: 7QWM220FJH)
CASTOR OIL (UNII: D5340Y2I9G)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82141-2352-1	1 in 1 CARTON	09/01/2025
1		10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2025

TOTY ILUMINA CC CREAMY COMPACT 3N 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82141-2348
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ALUMINUM OXIDE (UNII: LMI26O6933)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
NYLON-12 (UNII: 446U8J075B)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
MICA (UNII: V8A1AW0880)
SQUALENE (UNII: 7QWM220FJH)
CASTOR OIL (UNII: D5340Y2I9G)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82141-2348-1	1 in 1 CARTON	09/01/2025
1		10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2025

TOTY ILUMINA CC CREAMY COMPACT 2N 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82141-2345
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ALUMINUM OXIDE (UNII: LMI26O6933)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
NYLON-12 (UNII: 446U8J075B)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
MICA (UNII: V8A1AW0880)
SQUALENE (UNII: 7QWM220FJH)
CASTOR OIL (UNII: D5340Y2I9G)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82141-2345-1	1 in 1 CARTON	09/01/2025
1		10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2025

Labeler - Chipican LLC (118132015)

Establishment
Name	Address	ID/FEI	Business Operations
Industrial Farmaceutica Cantabria SA		470471158	manufacture(82141-2344, 82141-2345, 82141-2346, 82141-2347, 82141-2348, 82141-2349, 82141-2350, 82141-2351, 82141-2352, 82141-2355, 82141-0913) , pack(82141-2344, 82141-2345, 82141-2346, 82141-2347, 82141-2348, 82141-2349, 82141-2350, 82141-2351, 82141-2352, 82141-2355, 82141-0913) , label(82141-2344, 82141-2345, 82141-2346, 82141-2347, 82141-2348, 82141-2349, 82141-2350, 82141-2351, 82141-2352, 82141-2355, 82141-0913)