toty Ilumina CC Creamy Compact 2W

toty Ilumina CC Creamy Compact (Godet, Chipican LLC)

Approved

Approval ID

3da732e7-19b0-3195-e063-6394a90a9a0c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 1, 2025

Manufacturers

FDA

Chipican LLC

DUNS: 118132015

Products 10

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Titanium Dioxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code82141-2345

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

Titanium Dioxide

Product Specifications

Route of AdministrationTOPICAL

Effective DateSeptember 1, 2025

FDA Product Classification

INGREDIENTS (29)

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

PARAFFINInactive

Code: I9O0E3H2ZE

Classification: IACT

ETHYLHEXYL PALMITATEInactive

Code: 2865993309

Classification: IACT

MICROCRYSTALLINE WAXInactive

Code: XOF597Q3KY

Classification: IACT

METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERInactive

Code: EG97988M5Q

Classification: IACT

POLY(METHYL METHACRYLATE; 450000 MW)Inactive

Code: Z47NNT4J11

Classification: IACT

TITANIUM DIOXIDEActive

Quantity: 10.4 g in 100 g

Code: 15FIX9V2JP

Classification: ACTIB

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

PHLEBODIUM AUREUM LEAFInactive

Code: BG58BW230G

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

MINERAL OILInactive

Code: T5L8T28FGP

Classification: IACT

1,2-BUTYLENE GLYCOL MONOCOCOATEInactive

Code: XK3264896J

Classification: IACT

SOYBEAN OILInactive

Code: 241ATL177A

Classification: IACT

HYDROGENATED CASTOR OILInactive

Code: ZF94AP8MEY

Classification: IACT

.ALPHA.-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

GLYCERYL CAPRYLATEInactive

Code: TM2TZD4G4A

Classification: IACT

TOCOPHEROLInactive

Code: R0ZB2556P8

Classification: IACT

NYLON-12Inactive

Code: 446U8J075B

Classification: IACT

HYDROGENATED POLYBUTENE (1300 MW)Inactive

Code: 7D1YQ9Y5EZ

Classification: IACT

MICAInactive

Code: V8A1AW0880

Classification: IACT

SQUALENEInactive

Code: 7QWM220FJH

Classification: IACT

CASTOR OILInactive

Code: D5340Y2I9G

Classification: IACT

.BETA.-SITOSTEROLInactive

Code: S347WMO6M4

Classification: IACT

LINALOOL, (+/-)-Inactive

Code: D81QY6I88E

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

Titanium Dioxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code82141-0913

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

Titanium Dioxide

Product Specifications

Route of AdministrationTOPICAL

Effective DateSeptember 1, 2025

FDA Product Classification

INGREDIENTS (32)

TITANIUM DIOXIDEActive

Quantity: 10.4 g in 100 g

Code: 15FIX9V2JP

Classification: ACTIB

.BETA.-SITOSTEROLInactive

Code: S347WMO6M4

Classification: IACT

MICROCRYSTALLINE WAXInactive

Code: XOF597Q3KY

Classification: IACT

SODIUM STEARATEInactive

Code: QU7E2XA9TG

Classification: IACT

CETEARETH-20Inactive

Code: YRC528SWUY

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

ETHYLHEXYL PALMITATEInactive

Code: 2865993309

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

HYDROGENATED CASTOR OILInactive

Code: ZF94AP8MEY

Classification: IACT

CASTOR OILInactive

Code: D5340Y2I9G

Classification: IACT

TRIETHOXYCAPRYLYLSILANEInactive

Code: LDC331P08E

Classification: IACT

MICAInactive

Code: V8A1AW0880

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

GLYCERYL CAPRYLATEInactive

Code: TM2TZD4G4A

Classification: IACT

NYLON-12Inactive

Code: 446U8J075B

Classification: IACT

.ALPHA.-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SOYBEAN OILInactive

Code: 241ATL177A

Classification: IACT

TOCOPHEROLInactive

Code: R0ZB2556P8

Classification: IACT

PARAFFINInactive

Code: I9O0E3H2ZE

Classification: IACT

1,2-BUTYLENE GLYCOL MONOCOCOATEInactive

Code: XK3264896J

Classification: IACT

SQUALENEInactive

Code: 7QWM220FJH

Classification: IACT

BISMUTH OXYCHLORIDEInactive

Code: 4ZR792I587

Classification: IACT

POLY(METHYL METHACRYLATE; 450000 MW)Inactive

Code: Z47NNT4J11

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

HYDROGENATED POLYISOBUTENE (1300 MW)Inactive

Code: 7D1YQ9Y5EZ

Classification: IACT

CETOSTEARYL ALCOHOLInactive

Code: 2DMT128M1S

Classification: IACT

CALCIUM CHLORIDEInactive

Code: M4I0D6VV5M

Classification: IACT

PHLEBODIUM AUREUM LEAFInactive

Code: BG58BW230G

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

Titanium Dioxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code82141-2352

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

Titanium Dioxide

Product Specifications

Route of AdministrationTOPICAL

Effective DateSeptember 1, 2025

FDA Product Classification

INGREDIENTS (30)

MICROCRYSTALLINE WAXInactive

Code: XOF597Q3KY

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

TITANIUM DIOXIDEActive

Quantity: 10.4 g in 100 g

Code: 15FIX9V2JP

Classification: ACTIB

PHLEBODIUM AUREUM LEAFInactive

Code: BG58BW230G

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

1,2-BUTYLENE GLYCOL MONOCOCOATEInactive

Code: XK3264896J

Classification: IACT

HYDROGENATED CASTOR OILInactive

Code: ZF94AP8MEY

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

PARAFFINInactive

Code: I9O0E3H2ZE

Classification: IACT

ETHYLHEXYL PALMITATEInactive

Code: 2865993309

Classification: IACT

METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERInactive

Code: EG97988M5Q

Classification: IACT

POLY(METHYL METHACRYLATE; 450000 MW)Inactive

Code: Z47NNT4J11

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

MINERAL OILInactive

Code: T5L8T28FGP

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

GLYCERYL CAPRYLATEInactive

Code: TM2TZD4G4A

Classification: IACT

SOYBEAN OILInactive

Code: 241ATL177A

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

.ALPHA.-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

TRIETHOXYCAPRYLYLSILANEInactive

Code: LDC331P08E

Classification: IACT

TOCOPHEROLInactive

Code: R0ZB2556P8

Classification: IACT

NYLON-12Inactive

Code: 446U8J075B

Classification: IACT

HYDROGENATED POLYBUTENE (1300 MW)Inactive

Code: 7D1YQ9Y5EZ

Classification: IACT

MICAInactive

Code: V8A1AW0880

Classification: IACT

SQUALENEInactive

Code: 7QWM220FJH

Classification: IACT

CASTOR OILInactive

Code: D5340Y2I9G

Classification: IACT

.BETA.-SITOSTEROLInactive

Code: S347WMO6M4

Classification: IACT

LINALOOL, (+/-)-Inactive

Code: D81QY6I88E

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

Titanium Dioxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code82141-2347

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

Titanium Dioxide

Product Specifications

Route of AdministrationTOPICAL

Effective DateSeptember 1, 2025

FDA Product Classification

INGREDIENTS (29)

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

ETHYLHEXYL PALMITATEInactive

Code: 2865993309

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

PARAFFINInactive

Code: I9O0E3H2ZE

Classification: IACT

MICROCRYSTALLINE WAXInactive

Code: XOF597Q3KY

Classification: IACT

METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERInactive

Code: EG97988M5Q

Classification: IACT

POLY(METHYL METHACRYLATE; 450000 MW)Inactive

Code: Z47NNT4J11

Classification: IACT

TITANIUM DIOXIDEActive

Quantity: 10.4 g in 100 g

Code: 15FIX9V2JP

Classification: ACTIB

PHLEBODIUM AUREUM LEAFInactive

Code: BG58BW230G

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

1,2-BUTYLENE GLYCOL MONOCOCOATEInactive

Code: XK3264896J

Classification: IACT

MINERAL OILInactive

Code: T5L8T28FGP

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

GLYCERYL CAPRYLATEInactive

Code: TM2TZD4G4A

Classification: IACT

HYDROGENATED POLYBUTENE (1300 MW)Inactive

Code: 7D1YQ9Y5EZ

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SOYBEAN OILInactive

Code: 241ATL177A

Classification: IACT

HYDROGENATED CASTOR OILInactive

Code: ZF94AP8MEY

Classification: IACT

.ALPHA.-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

TOCOPHEROLInactive

Code: R0ZB2556P8

Classification: IACT

NYLON-12Inactive

Code: 446U8J075B

Classification: IACT

MICAInactive

Code: V8A1AW0880

Classification: IACT

SQUALENEInactive

Code: 7QWM220FJH

Classification: IACT

CASTOR OILInactive

Code: D5340Y2I9G

Classification: IACT

.BETA.-SITOSTEROLInactive

Code: S347WMO6M4

Classification: IACT

LINALOOL, (+/-)-Inactive

Code: D81QY6I88E

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

Titanium Dioxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code82141-2344

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

Titanium Dioxide

Product Specifications

Route of AdministrationTOPICAL

Effective DateSeptember 1, 2025

FDA Product Classification

INGREDIENTS (28)

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

PARAFFINInactive

Code: I9O0E3H2ZE

Classification: IACT

ETHYLHEXYL PALMITATEInactive

Code: 2865993309

Classification: IACT

MICROCRYSTALLINE WAXInactive

Code: XOF597Q3KY

Classification: IACT

METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERInactive

Code: EG97988M5Q

Classification: IACT

POLY(METHYL METHACRYLATE; 450000 MW)Inactive

Code: Z47NNT4J11

Classification: IACT

TITANIUM DIOXIDEActive

Quantity: 10.4 g in 100 g

Code: 15FIX9V2JP

Classification: ACTIB

PHLEBODIUM AUREUM LEAFInactive

Code: BG58BW230G

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

MINERAL OILInactive

Code: T5L8T28FGP

Classification: IACT

1,2-BUTYLENE GLYCOL MONOCOCOATEInactive

Code: XK3264896J

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SOYBEAN OILInactive

Code: 241ATL177A

Classification: IACT

HYDROGENATED CASTOR OILInactive

Code: ZF94AP8MEY

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

GLYCERYL CAPRYLATEInactive

Code: TM2TZD4G4A

Classification: IACT

.ALPHA.-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

TOCOPHEROLInactive

Code: R0ZB2556P8

Classification: IACT

NYLON-12Inactive

Code: 446U8J075B

Classification: IACT

HYDROGENATED POLYBUTENE (1300 MW)Inactive

Code: 7D1YQ9Y5EZ

Classification: IACT

MICAInactive

Code: V8A1AW0880

Classification: IACT

SQUALENEInactive

Code: 7QWM220FJH

Classification: IACT

CASTOR OILInactive

Code: D5340Y2I9G

Classification: IACT

.BETA.-SITOSTEROLInactive

Code: S347WMO6M4

Classification: IACT

LINALOOL, (+/-)-Inactive

Code: D81QY6I88E

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

Titanium Dioxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code82141-2351

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

Titanium Dioxide

Product Specifications

Route of AdministrationTOPICAL

Effective DateSeptember 1, 2025

FDA Product Classification

INGREDIENTS (29)

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POLY(METHYL METHACRYLATE; 450000 MW)Inactive

Code: Z47NNT4J11

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

PARAFFINInactive

Code: I9O0E3H2ZE

Classification: IACT

ETHYLHEXYL PALMITATEInactive

Code: 2865993309

Classification: IACT

1,2-BUTYLENE GLYCOL MONOCOCOATEInactive

Code: XK3264896J

Classification: IACT

MICROCRYSTALLINE WAXInactive

Code: XOF597Q3KY

Classification: IACT

METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERInactive

Code: EG97988M5Q

Classification: IACT

PHLEBODIUM AUREUM LEAFInactive

Code: BG58BW230G

Classification: IACT

TITANIUM DIOXIDEActive

Quantity: 10.4 g in 100 g

Code: 15FIX9V2JP

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

HYDROGENATED CASTOR OILInactive

Code: ZF94AP8MEY

Classification: IACT

MINERAL OILInactive

Code: T5L8T28FGP

Classification: IACT

MICAInactive

Code: V8A1AW0880

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SOYBEAN OILInactive

Code: 241ATL177A

Classification: IACT

.ALPHA.-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

GLYCERYL CAPRYLATEInactive

Code: TM2TZD4G4A

Classification: IACT

TOCOPHEROLInactive

Code: R0ZB2556P8

Classification: IACT

NYLON-12Inactive

Code: 446U8J075B

Classification: IACT

SQUALENEInactive

Code: 7QWM220FJH

Classification: IACT

CASTOR OILInactive

Code: D5340Y2I9G

Classification: IACT

HYDROGENATED POLYBUTENE (1300 MW)Inactive

Code: 7D1YQ9Y5EZ

Classification: IACT

.BETA.-SITOSTEROLInactive

Code: S347WMO6M4

Classification: IACT

LINALOOL, (+/-)-Inactive

Code: D81QY6I88E

Classification: IACT

Titanium Dioxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code82141-2350

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

Titanium Dioxide

Product Specifications

Route of AdministrationTOPICAL

Effective DateSeptember 1, 2025

FDA Product Classification

INGREDIENTS (30)

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

PARAFFINInactive

Code: I9O0E3H2ZE

Classification: IACT

MICROCRYSTALLINE WAXInactive

Code: XOF597Q3KY

Classification: IACT

ETHYLHEXYL PALMITATEInactive

Code: 2865993309

Classification: IACT

METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERInactive

Code: EG97988M5Q

Classification: IACT

POLY(METHYL METHACRYLATE; 450000 MW)Inactive

Code: Z47NNT4J11

Classification: IACT

TITANIUM DIOXIDEActive

Quantity: 10.4 g in 100 g

Code: 15FIX9V2JP

Classification: ACTIB

PHLEBODIUM AUREUM LEAFInactive

Code: BG58BW230G

Classification: IACT

HYDROGENATED CASTOR OILInactive

Code: ZF94AP8MEY

Classification: IACT

.ALPHA.-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

MINERAL OILInactive

Code: T5L8T28FGP

Classification: IACT

1,2-BUTYLENE GLYCOL MONOCOCOATEInactive

Code: XK3264896J

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SOYBEAN OILInactive

Code: 241ATL177A

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

GLYCERYL CAPRYLATEInactive

Code: TM2TZD4G4A

Classification: IACT

TOCOPHEROLInactive

Code: R0ZB2556P8

Classification: IACT

NYLON-12Inactive

Code: 446U8J075B

Classification: IACT

HYDROGENATED POLYBUTENE (1300 MW)Inactive

Code: 7D1YQ9Y5EZ

Classification: IACT

SQUALENEInactive

Code: 7QWM220FJH

Classification: IACT

MICAInactive

Code: V8A1AW0880

Classification: IACT

BISMUTH OXYCHLORIDEInactive

Code: 4ZR792I587

Classification: IACT

CASTOR OILInactive

Code: D5340Y2I9G

Classification: IACT

.BETA.-SITOSTEROLInactive

Code: S347WMO6M4

Classification: IACT

LINALOOL, (+/-)-Inactive

Code: D81QY6I88E

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

Titanium Dioxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code82141-2355

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

Titanium Dioxide

Product Specifications

Route of AdministrationTOPICAL

Effective DateSeptember 1, 2025

FDA Product Classification

INGREDIENTS (30)

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

PARAFFINInactive

Code: I9O0E3H2ZE

Classification: IACT

ETHYLHEXYL PALMITATEInactive

Code: 2865993309

Classification: IACT

MINERAL OILInactive

Code: T5L8T28FGP

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

MICROCRYSTALLINE WAXInactive

Code: XOF597Q3KY

Classification: IACT

METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERInactive

Code: EG97988M5Q

Classification: IACT

TITANIUM DIOXIDEActive

Quantity: 10.4 g in 100 g

Code: 15FIX9V2JP

Classification: ACTIB

POLY(METHYL METHACRYLATE; 450000 MW)Inactive

Code: Z47NNT4J11

Classification: IACT

PHLEBODIUM AUREUM LEAFInactive

Code: BG58BW230G

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

1,2-BUTYLENE GLYCOL MONOCOCOATEInactive

Code: XK3264896J

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

SOYBEAN OILInactive

Code: 241ATL177A

Classification: IACT

HYDROGENATED CASTOR OILInactive

Code: ZF94AP8MEY

Classification: IACT

.ALPHA.-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

HYDROGENATED POLYBUTENE (1300 MW)Inactive

Code: 7D1YQ9Y5EZ

Classification: IACT

MICAInactive

Code: V8A1AW0880

Classification: IACT

GLYCERYL CAPRYLATEInactive

Code: TM2TZD4G4A

Classification: IACT

TOCOPHEROLInactive

Code: R0ZB2556P8

Classification: IACT

NYLON-12Inactive

Code: 446U8J075B

Classification: IACT

SQUALENEInactive

Code: 7QWM220FJH

Classification: IACT

CASTOR OILInactive

Code: D5340Y2I9G

Classification: IACT

.BETA.-SITOSTEROLInactive

Code: S347WMO6M4

Classification: IACT

LINALOOL, (+/-)-Inactive

Code: D81QY6I88E

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

TRIETHOXYCAPRYLYLSILANEInactive

Code: LDC331P08E

Classification: IACT

Titanium Dioxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code82141-2346

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

Titanium Dioxide

Product Specifications

Route of AdministrationTOPICAL

Effective DateSeptember 1, 2025

FDA Product Classification

INGREDIENTS (29)

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

MICROCRYSTALLINE WAXInactive

Code: XOF597Q3KY

Classification: IACT

PARAFFINInactive

Code: I9O0E3H2ZE

Classification: IACT

ETHYLHEXYL PALMITATEInactive

Code: 2865993309

Classification: IACT

METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERInactive

Code: EG97988M5Q

Classification: IACT

POLY(METHYL METHACRYLATE; 450000 MW)Inactive

Code: Z47NNT4J11

Classification: IACT

TITANIUM DIOXIDEActive

Quantity: 10.4 g in 100 g

Code: 15FIX9V2JP

Classification: ACTIB

PHLEBODIUM AUREUM LEAFInactive

Code: BG58BW230G

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

MINERAL OILInactive

Code: T5L8T28FGP

Classification: IACT

1,2-BUTYLENE GLYCOL MONOCOCOATEInactive

Code: XK3264896J

Classification: IACT

SOYBEAN OILInactive

Code: 241ATL177A

Classification: IACT

HYDROGENATED CASTOR OILInactive

Code: ZF94AP8MEY

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

GLYCERYL CAPRYLATEInactive

Code: TM2TZD4G4A

Classification: IACT

NYLON-12Inactive

Code: 446U8J075B

Classification: IACT

.ALPHA.-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

TOCOPHEROLInactive

Code: R0ZB2556P8

Classification: IACT

SQUALENEInactive

Code: 7QWM220FJH

Classification: IACT

HYDROGENATED POLYBUTENE (1300 MW)Inactive

Code: 7D1YQ9Y5EZ

Classification: IACT

MICAInactive

Code: V8A1AW0880

Classification: IACT

CASTOR OILInactive

Code: D5340Y2I9G

Classification: IACT

.BETA.-SITOSTEROLInactive

Code: S347WMO6M4

Classification: IACT

LINALOOL, (+/-)-Inactive

Code: D81QY6I88E

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

Titanium Dioxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code82141-2349

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

Titanium Dioxide

Product Specifications

Route of AdministrationTOPICAL

Effective DateSeptember 1, 2025

FDA Product Classification

INGREDIENTS (30)

MICAInactive

Code: V8A1AW0880

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

TITANIUM DIOXIDEActive

Quantity: 10.4 g in 100 g

Code: 15FIX9V2JP

Classification: ACTIB

1,2-BUTYLENE GLYCOL MONOCOCOATEInactive

Code: XK3264896J

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

PARAFFINInactive

Code: I9O0E3H2ZE

Classification: IACT

METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERInactive

Code: EG97988M5Q

Classification: IACT

ETHYLHEXYL PALMITATEInactive

Code: 2865993309

Classification: IACT

MICROCRYSTALLINE WAXInactive

Code: XOF597Q3KY

Classification: IACT

POLY(METHYL METHACRYLATE; 450000 MW)Inactive

Code: Z47NNT4J11

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

MINERAL OILInactive

Code: T5L8T28FGP

Classification: IACT

PHLEBODIUM AUREUM LEAFInactive

Code: BG58BW230G

Classification: IACT

SOYBEAN OILInactive

Code: 241ATL177A

Classification: IACT

.ALPHA.-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

HYDROGENATED CASTOR OILInactive

Code: ZF94AP8MEY

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

GLYCERYL CAPRYLATEInactive

Code: TM2TZD4G4A

Classification: IACT

TOCOPHEROLInactive

Code: R0ZB2556P8

Classification: IACT

NYLON-12Inactive

Code: 446U8J075B

Classification: IACT

HYDROGENATED POLYBUTENE (1300 MW)Inactive

Code: 7D1YQ9Y5EZ

Classification: IACT

SQUALENEInactive

Code: 7QWM220FJH

Classification: IACT

CASTOR OILInactive

Code: D5340Y2I9G

Classification: IACT

.BETA.-SITOSTEROLInactive

Code: S347WMO6M4

Classification: IACT

LINALOOL, (+/-)-Inactive

Code: D81QY6I88E

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

TRIETHOXYCAPRYLYLSILANEInactive

Code: LDC331P08E

Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/1/2025

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

toty Ilumina CC Creamy Compact 1C 6N

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/1/2025

Uses

Helps prevent sunburn
If used as directed with other sun protection measures (seeDirections), decreases the risk of skin cancer and early skin aging caused by the sun

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/1/2025

Active Ingredient

Titanium Dioxide- 10.4%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/1/2025

Purpose

Sunscreen

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/1/2025

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/1/2025

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

WARNINGS SECTION

LOINC: 34071-1Updated: 9/1/2025

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/1/2025

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.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/1/2025

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.

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Titanium Dioxide

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INGREDIENTS (29)

Titanium Dioxide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (32)

Titanium Dioxide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (30)

Titanium Dioxide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (29)

Titanium Dioxide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (28)

Titanium Dioxide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (29)

Titanium Dioxide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (30)

Titanium Dioxide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (30)

Titanium Dioxide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (29)

Titanium Dioxide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (30)

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

toty Ilumina CC Creamy Compact 6N

INDICATIONS & USAGE SECTION

Uses

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

OTC - PURPOSE SECTION

Purpose

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

STORAGE AND HANDLING SECTION

Other Information

WARNINGS SECTION

Warnings

DOSAGE & ADMINISTRATION SECTION

INACTIVE INGREDIENT SECTION