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. If swallowed, get medical help or contact a Poison Control Center right away.

Apply liberally 15 minutes behore sun exposure
Reapply:

After 80 minutes of swimming or sweating

immediately after towel drying

Atleat 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 82141-2357-1, 82141-2358-1, 82141-2360-1, 82141-2363-1

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 82141-2359-1, 82141-2362-1

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 82141-2361-1, 82141-2365-1, 82141-2368-1

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 82141-2364-1

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 82141-2366-1

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 82141-2367-1

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.

NDCs 82141-2369-1

Hydrogenated Polyisobutene; Ethylhexyl Palmitate; Nylon-12; Paraffin; Hydrogenated Microcrystalline Wax;

Butylene Glycol Cocoate; Polymethyl Methacrylate; Mica; 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.

NDCs 82141-2370-1, 82141-2371-1

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.

Package Label.Principal Display Panel- 1N

NDC 82141-2357-1 (toty Ilumina CC Creamy Compact Refill 1N)

toty.

REFILL/RECARGA

ILUMINA

CC CREAMY COMPACT REFILL

SPF 50+

TONE-ADAPTING, SILKY-SMOOTH COMPACT

COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE

.....................................................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

VERY WATER RESISTANT (80 MINUTES)

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

MUY RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

Toty Ilumina CC Creamy Compact Refill 1N

Package Label.Principal Display Panel- 1W

NDC 82141-2358-1 (toty Ilumina CC Creamy Compact Refill 1W)

toty.

REFILL/RECARGA

ILUMINA

CC CREAMY COMPACT REFILL

SPF 50+

TONE-ADAPTING, SILKY-SMOOTH COMPACT

COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE

.....................................................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

VERY WATER RESISTANT (80 MINUTES)

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

MUY RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

Toty Ilumina CC Creamy Compact Refill 1W

Package Label.Principal Display Panel- 1C

NDC 82141-2359-1 (toty Ilumina CC Creamy Compact Refill 1C)

toty.

REFILL/RECARGA

ILUMINA

CC CREAMY COMPACT REFILL

SPF 50+

TONE-ADAPTING, SILKY-SMOOTH COMPACT

COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE

.....................................................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

VERY WATER RESISTANT (80 MINUTES)

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

MUY RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

toty Ilumina CC Creamy Compact Refil 1C

Package Label.Principal Display Panel- 2N

NDC 82141-2360-1 (toty Ilumina CC Creamy Compact Refill 2N)

toty.

REFILL/RECARGA

ILUMINA

CC CREAMY COMPACT REFILL

SPF 50+

TONE-ADAPTING, SILKY-SMOOTH COMPACT

COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE

.....................................................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

VERY WATER RESISTANT (80 MINUTES)

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

MUY RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

toty Ilumina CC Creamy Compact Refil 2N

Package Label.Principal Display Panel- 2W

NDC 82141-2361-1 (toty Ilumina CC Creamy Compact Refill 2W)

toty.

REFILL/RECARGA

ILUMINA

CC CREAMY COMPACT REFILL

SPF 50+

TONE-ADAPTING, SILKY-SMOOTH COMPACT

COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE

.....................................................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

VERY WATER RESISTANT (80 MINUTES)

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

MUY RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

Toty Ilumina CC Creamy Compact Refill 2W

Package Label.Principal Display Panel- 2C

NDC 82141-2362-1 (toty Ilumina CC Creamy Compact Refill 2C)

toty.

REFILL/RECARGA

ILUMINA

CC CREAMY COMPACT REFILL

SPF 50+

TONE-ADAPTING, SILKY-SMOOTH COMPACT

COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE

.....................................................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

VERY WATER RESISTANT (80 MINUTES)

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

MUY RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

toty Ilumina CC Creamy Compact Refil 2C

Package Label.Principal Display Panel- 3N

NDC 82141-2363-1 (toty Ilumina CC Creamy Compact Refill 3N)

toty.

REFILL/RECARGA

ILUMINA

CC CREAMY COMPACT REFILL

SPF 50+

TONE-ADAPTING, SILKY-SMOOTH COMPACT

COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE

.....................................................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

VERY WATER RESISTANT (80 MINUTES)

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

MUY RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

toty Ilumina CC Creamy Compact Refil 3N

Package Label.Principal Display Panel- 3W

NDC 82141-2364-1 (toty Ilumina CC Creamy Compact Refill 3W)

toty.

REFILL/RECARGA

ILUMINA

CC CREAMY COMPACT REFILL

SPF 50+

TONE-ADAPTING, SILKY-SMOOTH COMPACT

COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE

.....................................................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

VERY WATER RESISTANT (80 MINUTES)

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

MUY RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

Toty Ilumina CC Creamy Compact Refill 3W

Package Label.Principal Display Panel- 3C

NDC 82141-2365-1 (toty Ilumina CC Creamy Compact Refill 3C)

toty.

REFILL/RECARGA

ILUMINA

CC CREAMY COMPACT REFILL

SPF 50+

TONE-ADAPTING, SILKY-SMOOTH COMPACT

COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE

.....................................................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

VERY WATER RESISTANT (80 MINUTES)

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

MUY RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

Toty Ilumina CC Creamy Compact Refill 3C

Package Label.Principal Display Panel- 4N

NDC 82141-2366-1 (toty Ilumina CC Creamy Compact Refill 4N)

toty.

REFILL/RECARGA

ILUMINA

CC CREAMY COMPACT REFILL

SPF 50+

TONE-ADAPTING, SILKY-SMOOTH COMPACT

COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE

.....................................................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

VERY WATER RESISTANT (80 MINUTES)

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

MUY RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

Toty Ilumina CC Creamy Compact Refill 4N

Package Label.Principal Display Panel- 4W

NDC 82141-2367-1 (toty Ilumina CC Creamy Compact Refill 4W)

toty.

REFILL/RECARGA

ILUMINA

CC CREAMY COMPACT REFILL

SPF 50+

TONE-ADAPTING, SILKY-SMOOTH COMPACT

COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE

.....................................................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

VERY WATER RESISTANT (80 MINUTES)

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

MUY RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

Toty Ilumina CC Creamy Compact Refill 4W

Package Label.Principal Display Panel- 4C

NDC 82141-2368-1 (toty Ilumina CC Creamy Compact Refill 4C)

toty.

REFILL/RECARGA

ILUMINA

CC CREAMY COMPACT REFILL

SPF 50+

TONE-ADAPTING, SILKY-SMOOTH COMPACT

COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE

.....................................................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

VERY WATER RESISTANT (80 MINUTES)

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

MUY RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

Toty Ilumina CC Creamy Compact Refill 4C

Package Label.Principal Display Panel- 5W

NDC 82141-2369-1 (toty Ilumina CC Creamy Compact Refill 5W)

toty.

REFILL/RECARGA

ILUMINA

CC CREAMY COMPACT REFILL

SPF 50+

TONE-ADAPTING, SILKY-SMOOTH COMPACT

COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE

.....................................................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

VERY WATER RESISTANT (80 MINUTES)

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

MUY RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

toty Ilumina CC Creamy Compact Refill 5W

Package Label.Principal Display Panel- 5W1

NDC 82141-2370-1 (toty Ilumina CC Creamy Compact Refill 5W1)

toty.

REFILL/RECARGA

ILUMINA

CC CREAMY COMPACT REFILL

SPF 50+

TONE-ADAPTING, SILKY-SMOOTH COMPACT

COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE

.....................................................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

VERY WATER RESISTANT (80 MINUTES)

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

MUY RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

Toty Ilumina CC Creamy Compact Refill 5W1

Package Label.Principal Display Panel- 5W2

NDC 82141-2371-1 (toty Ilumina CC Creamy Compact Refill 5W2)

toty.

REFILL/RECARGA

ILUMINA

CC CREAMY COMPACT REFILL

SPF 50+

TONE-ADAPTING, SILKY-SMOOTH COMPACT

COMPACTO SUAVE, SEDOSO, TONO-ADAPTABLE

.....................................................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

VERY WATER RESISTANT (80 MINUTES)

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

MUY RESISTENTE AL AGUA (80 MINUTOS)

0.35 oz/10g

Toty Ilumina CC Creamy Compact Refill 5W2

TOTY ILUMINA CC CREAMY COMPACT REFILL 4C
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2368
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ALUMINUM OXIDE (UNII: LMI26O6933)
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)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2368-1	1 in 1 CARTON	05/31/2023
1		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	05/31/2023

TOTY ILUMINA CC CREAMY COMPACT REFILL 3C
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2365
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ALUMINUM OXIDE (UNII: LMI26O6933)
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)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2365-1	1 in 1 CARTON	05/31/2023
1		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	05/31/2023

TOTY ILUMINA CC CREAMY COMPACT REFILL 3W
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2364
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ALUMINUM OXIDE (UNII: LMI26O6933)
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)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2364-1	1 in 1 CARTON	05/31/2023
1		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	05/31/2023

TOTY ILUMINA CC CREAMY COMPACT REFILL 4N
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2366
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ALUMINUM OXIDE (UNII: LMI26O6933)
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)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2366-1	1 in 1 CARTON	05/31/2023
1		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	05/31/2023

TOTY ILUMINA CC CREAMY COMPACT REFILL 1C
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2359
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ALUMINUM OXIDE (UNII: LMI26O6933)
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)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2359-1	1 in 1 CARTON	05/31/2023
1		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	05/31/2023

TOTY ILUMINA CC CREAMY COMPACT REFILL 2W
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2361
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ALUMINUM OXIDE (UNII: LMI26O6933)
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)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2361-1	1 in 1 CARTON	05/31/2023
1		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	05/31/2023

TOTY ILUMINA CC CREAMY COMPACT REFILL 5W1
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2370
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ALUMINUM OXIDE (UNII: LMI26O6933)
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)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2370-1	1 in 1 CARTON	05/31/2023
1		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	05/31/2023

TOTY ILUMINA CC CREAMY COMPACT REFILL 5W2
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2371
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ALUMINUM OXIDE (UNII: LMI26O6933)
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)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2371-1	1 in 1 CARTON	05/31/2023
1		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	05/31/2023

TOTY ILUMINA CC CREAMY COMPACT REFILL 3N
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2363
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ALUMINUM OXIDE (UNII: LMI26O6933)
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)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2363-1	1 in 1 CARTON	05/31/2023
1		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	05/31/2023

TOTY ILUMINA CC CREAMY COMPACT REFILL 1N
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2357
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ALUMINUM OXIDE (UNII: LMI26O6933)
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)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2357-1	1 in 1 CARTON	05/31/2023
1		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	05/31/2023

TOTY ILUMINA CC CREAMY COMPACT REFILL 1W
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2358
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ALUMINUM OXIDE (UNII: LMI26O6933)
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)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2358-1	1 in 1 CARTON	05/31/2023
1		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	05/31/2023

TOTY ILUMINA CC CREAMY COMPACT REFILL 2N
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2360
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ALUMINUM OXIDE (UNII: LMI26O6933)
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)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2360-1	1 in 1 CARTON	05/31/2023
1		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	05/31/2023

TOTY ILUMINA CC CREAMY COMPACT REFILL 2C
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2362
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ALUMINUM OXIDE (UNII: LMI26O6933)
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)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2362-1	1 in 1 CARTON	05/31/2023
1		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	05/31/2023

TOTY ILUMINA CC CREAMY COMPACT REFILL 4W
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2367
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ALUMINUM OXIDE (UNII: LMI26O6933)
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)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2367-1	1 in 1 CARTON	05/31/2023
1		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	05/31/2023

TOTY ILUMINA CC CREAMY COMPACT REFILL 5W
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2369
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
1,2-BUTYLENE GLYCOL MONOCOCOATE (UNII: XK3264896J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ALUMINUM OXIDE (UNII: LMI26O6933)
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)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2369-1	1 in 1 CARTON	05/31/2023
1		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	05/31/2023

Labeler - Chipican LLC (118132015)

Name	Address	ID/FEI	Business Operations
Establishment
Industrial Farmaceutica Cantabria SA		470471158	manufacture(82141-2357, 82141-2358, 82141-2359, 82141-2360, 82141-2361, 82141-2362, 82141-2363, 82141-2364, 82141-2365, 82141-2366, 82141-2367, 82141-2368, 82141-2369, 82141-2370, 82141-2371) , pack(82141-2357, 82141-2358, 82141-2359, 82141-2360, 82141-2361, 82141-2362, 82141-2363, 82141-2364, 82141-2365, 82141-2366, 82141-2367, 82141-2368, 82141-2369, 82141-2370, 82141-2371) , label(82141-2357, 82141-2358, 82141-2359, 82141-2360, 82141-2361, 82141-2362, 82141-2363, 82141-2364, 82141-2365, 82141-2366, 82141-2367, 82141-2368, 82141-2369, 82141-2370, 82141-2371)