DailyMed - TOTY ILUMINA CC CREAMY COMPACT REFILL 4C- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT REFILL 3C- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT REFILL 3W- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT REFILL 4N- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT REFILL 1C- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT REFILL 2W- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT REFILL 5W1- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT REFILL 5W2- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT REFILL 3N- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT REFILL 1N- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT REFILL 1W- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT REFILL 2N- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT REFILL 2C- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT REFILL 4W- titanium dioxide cream TOTY ILUMINA CC CREAMY COMPACT REFILL 5W- titanium dioxide cream

NDC Code(s): 82141-2357-1, 82141-2358-1, 82141-2359-1, 82141-2360-1, view more
82141-2361-1, 82141-2362-1, 82141-2363-1, 82141-2364-1, 82141-2365-1, 82141-2366-1, 82141-2367-1, 82141-2368-1, 82141-2369-1, 82141-2370-1, 82141-2371-1
Packager: Chipican LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated December 18, 2023

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

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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

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

INGREDIENTS AND APPEARANCE

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)

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Published Date (What is this?)	Version	Files
Dec 22, 2023	2 (current)	download
May 31, 2023	1	download

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	NDC
1	82141-2357-1
2	82141-2358-1
3	82141-2359-1
4	82141-2360-1
5	82141-2361-1
6	82141-2362-1
7	82141-2363-1
8	82141-2364-1
9	82141-2365-1
10	82141-2366-1
11	82141-2367-1
12	82141-2368-1
13	82141-2369-1
14	82141-2370-1
15	82141-2371-1

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Number of versions: 2

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