cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL

clé de peau BEAUTÉ RADIANT FLUID FOUNDATION NATURAL

Approved

Approval ID

4490f968-46b6-44d2-af2d-5130b52c8861

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 21, 2025

Manufacturers

FDA

SHISEIDO AMERICAS CORPORATION

DUNS: 193691821

Products 10

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

OCTINOXATE and TITANIUM DIOXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code58411-900

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

OCTINOXATE and TITANIUM DIOXIDE

Product Specifications

Route of AdministrationTOPICAL

Effective DateMay 21, 2025

FDA Product Classification

INGREDIENTS (54)

WATERInactive

Code: 059QF0KO0R

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

BUTYLENE GLYCOLInactive

Code: 3XUS85K0RA

Classification: IACT

TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)Inactive

Code: 5041RX63GN

Classification: IACT

POLYMETHYLSILSESQUIOXANE (11 MICRONS)Inactive

Code: Z570VEV8XK

Classification: IACT

ISODODECANEInactive

Code: A8289P68Y2

Classification: IACT

CAPRYLYL TRISILOXANEInactive

Code: Q95M2P1KJL

Classification: IACT

BIS(BUTYLAMINO)DIMETHYLSILANEInactive

Code: YG6YAQ6XCX

Classification: IACT

PEG-10 DIMETHICONE (200 CST)Inactive

Code: 287GF3Y3WC

Classification: IACT

ISOPROPYL MYRISTATEInactive

Code: 0RE8K4LNJS

Classification: IACT

MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEInactive

Code: YK3DC63Y5M

Classification: IACT

DIMETHICONE/PEG-10/15 CROSSPOLYMERInactive

Code: 21AS8B1BSS

Classification: IACT

ERYTHRINInactive

Code: 4TJZ1118I8

Classification: IACT

XYLITOLInactive

Code: VCQ006KQ1E

Classification: IACT

BARIUM SULFATEInactive

Code: 25BB7EKE2E

Classification: IACT

CYDONIA OBLONGA SEEDInactive

Code: JXU526QH1V

Classification: IACT

TREHALOSEInactive

Code: B8WCK70T7I

Classification: IACT

ARGAN OILInactive

Code: 4V59G5UW9X

Classification: IACT

GLYCINEInactive

Code: TE7660XO1C

Classification: IACT

PEG/PPG-14/7 DIMETHYL ETHERInactive

Code: 6DNW9T7YT2

Classification: IACT

CITRUS JUNOS SEEDInactive

Code: UY43O1Q45N

Classification: IACT

ROSA ROXBURGHII FRUITInactive

Code: CVT1AA87FF

Classification: IACT

ANGELICA ACUTILOBA ROOTInactive

Code: 3W51R3EK30

Classification: IACT

HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW)Inactive

Code: 2428CXY2LA

Classification: IACT

HYDROLYZED SHEEP WOOL KERATIN (200 MW)Inactive

Code: R6K7AW17SU

Classification: IACT

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)Inactive

Code: H895X08VNQ

Classification: IACT

PERILLA FRUTESCENS LEAFInactive

Code: T4L5881Y68

Classification: IACT

ISOSTEARIC ACIDInactive

Code: X33R8U0062

Classification: IACT

BEHENYL PHOSPHATEInactive

Code: 366D9UAY69

Classification: IACT

DIISOSTEARYL MALATEInactive

Code: QBS8A3XZGQ

Classification: IACT

DISTEARDIMONIUM HECTORITEInactive

Code: X687XDK09L

Classification: IACT

ALUMINUM HYDROXIDEInactive

Code: 5QB0T2IUN0

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

EDETATE TRISODIUMInactive

Code: 420IP921MB

Classification: IACT

POLYSILICONE-15Inactive

Code: F8DRP5BB29

Classification: IACT

TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONEInactive

Code: X75PL53TZJ

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

CITRIC ACID ACETATEInactive

Code: DSO12WL7AU

Classification: IACT

SODIUM CITRATE, UNSPECIFIED FORMInactive

Code: 1Q73Q2JULR

Classification: IACT

TRIETHOXYCAPRYLYLSILANEInactive

Code: LDC331P08E

Classification: IACT

DIPROPYLENE GLYCOLInactive

Code: E107L85C40

Classification: IACT

TOCOPHEROLInactive

Code: R0ZB2556P8

Classification: IACT

DISODIUM STEAROYL GLUTAMATEInactive

Code: 45ASM2L11M

Classification: IACT

SODIUM METABISULFITEInactive

Code: 4VON5FNS3C

Classification: IACT

THEANINEInactive

Code: 8021PR16QO

Classification: IACT

PHENOXYETHANOLInactive

Code: HIE492ZZ3T

Classification: IACT

METHYLPARABENInactive

Code: A2I8C7HI9T

Classification: IACT

FRAGRANCE 13576Inactive

Code: 5EM498GW35

Classification: IACT

BROWN IRON OXIDEInactive

Code: 1N032N7MFO

Classification: IACT

MICAInactive

Code: V8A1AW0880

Classification: IACT

OCTINOXATEActive

Quantity: 1.715 g in 35 mL

Code: 4Y5P7MUD51

Classification: ACTIB

TITANIUM DIOXIDEActive

Quantity: 1.155 g in 35 mL

Code: 15FIX9V2JP

Classification: ACTIB

OCTINOXATE and TITANIUM DIOXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code58411-910

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

OCTINOXATE and TITANIUM DIOXIDE

Product Specifications

Route of AdministrationTOPICAL

Effective DateMay 21, 2025

FDA Product Classification

INGREDIENTS (54)

ROSA ROXBURGHII FRUITInactive

Code: CVT1AA87FF

Classification: IACT

DISTEARDIMONIUM HECTORITEInactive

Code: X687XDK09L

Classification: IACT

EDETATE TRISODIUMInactive

Code: 420IP921MB

Classification: IACT

POLYSILICONE-15Inactive

Code: F8DRP5BB29

Classification: IACT

TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONEInactive

Code: X75PL53TZJ

Classification: IACT

PEG/PPG-14/7 DIMETHYL ETHERInactive

Code: 6DNW9T7YT2

Classification: IACT

CITRUS JUNOS SEEDInactive

Code: UY43O1Q45N

Classification: IACT

PERILLA FRUTESCENS LEAFInactive

Code: T4L5881Y68

Classification: IACT

ISOSTEARIC ACIDInactive

Code: X33R8U0062

Classification: IACT

DIISOSTEARYL MALATEInactive

Code: QBS8A3XZGQ

Classification: IACT

ANGELICA ACUTILOBA ROOTInactive

Code: 3W51R3EK30

Classification: IACT

HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW)Inactive

Code: 2428CXY2LA

Classification: IACT

HYDROLYZED SHEEP WOOL KERATIN (200 MW)Inactive

Code: R6K7AW17SU

Classification: IACT

BEHENYL PHOSPHATEInactive

Code: 366D9UAY69

Classification: IACT

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)Inactive

Code: H895X08VNQ

Classification: IACT

ALUMINUM HYDROXIDEInactive

Code: 5QB0T2IUN0

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

DISODIUM STEAROYL GLUTAMATEInactive

Code: 45ASM2L11M

Classification: IACT

SODIUM METABISULFITEInactive

Code: 4VON5FNS3C

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

CITRIC ACID ACETATEInactive

Code: DSO12WL7AU

Classification: IACT

SODIUM CITRATE, UNSPECIFIED FORMInactive

Code: 1Q73Q2JULR

Classification: IACT

TRIETHOXYCAPRYLYLSILANEInactive

Code: LDC331P08E

Classification: IACT

DIPROPYLENE GLYCOLInactive

Code: E107L85C40

Classification: IACT

THEANINEInactive

Code: 8021PR16QO

Classification: IACT

PHENOXYETHANOLInactive

Code: HIE492ZZ3T

Classification: IACT

METHYLPARABENInactive

Code: A2I8C7HI9T

Classification: IACT

FRAGRANCE 13576Inactive

Code: 5EM498GW35

Classification: IACT

BROWN IRON OXIDEInactive

Code: 1N032N7MFO

Classification: IACT

MICAInactive

Code: V8A1AW0880

Classification: IACT

OCTINOXATEActive

Quantity: 1.715 g in 35 mL

Code: 4Y5P7MUD51

Classification: ACTIB

TITANIUM DIOXIDEActive

Quantity: 1.155 g in 35 mL

Code: 15FIX9V2JP

Classification: ACTIB

WATERInactive

Code: 059QF0KO0R

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

BUTYLENE GLYCOLInactive

Code: 3XUS85K0RA

Classification: IACT

TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)Inactive

Code: 5041RX63GN

Classification: IACT

POLYMETHYLSILSESQUIOXANE (11 MICRONS)Inactive

Code: Z570VEV8XK

Classification: IACT

ISODODECANEInactive

Code: A8289P68Y2

Classification: IACT

CAPRYLYL TRISILOXANEInactive

Code: Q95M2P1KJL

Classification: IACT

BIS(BUTYLAMINO)DIMETHYLSILANEInactive

Code: YG6YAQ6XCX

Classification: IACT

PEG-10 DIMETHICONE (200 CST)Inactive

Code: 287GF3Y3WC

Classification: IACT

ISOPROPYL MYRISTATEInactive

Code: 0RE8K4LNJS

Classification: IACT

MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEInactive

Code: YK3DC63Y5M

Classification: IACT

DIMETHICONE/PEG-10/15 CROSSPOLYMERInactive

Code: 21AS8B1BSS

Classification: IACT

ERYTHRINInactive

Code: 4TJZ1118I8

Classification: IACT

XYLITOLInactive

Code: VCQ006KQ1E

Classification: IACT

BARIUM SULFATEInactive

Code: 25BB7EKE2E

Classification: IACT

CYDONIA OBLONGA SEEDInactive

Code: JXU526QH1V

Classification: IACT

TREHALOSEInactive

Code: B8WCK70T7I

Classification: IACT

TOCOPHEROLInactive

Code: R0ZB2556P8

Classification: IACT

ARGAN OILInactive

Code: 4V59G5UW9X

Classification: IACT

GLYCINEInactive

Code: TE7660XO1C

Classification: IACT

OCTINOXATE and TITANIUM DIOXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code58411-920

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

OCTINOXATE and TITANIUM DIOXIDE

Product Specifications

Route of AdministrationTOPICAL

Effective DateMay 21, 2025

FDA Product Classification

INGREDIENTS (54)

BARIUM SULFATEInactive

Code: 25BB7EKE2E

Classification: IACT

CAPRYLYL TRISILOXANEInactive

Code: Q95M2P1KJL

Classification: IACT

PEG-10 DIMETHICONE (200 CST)Inactive

Code: 287GF3Y3WC

Classification: IACT

MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEInactive

Code: YK3DC63Y5M

Classification: IACT

DIMETHICONE/PEG-10/15 CROSSPOLYMERInactive

Code: 21AS8B1BSS

Classification: IACT

TREHALOSEInactive

Code: B8WCK70T7I

Classification: IACT

ARGAN OILInactive

Code: 4V59G5UW9X

Classification: IACT

GLYCINEInactive

Code: TE7660XO1C

Classification: IACT

BIS(BUTYLAMINO)DIMETHYLSILANEInactive

Code: YG6YAQ6XCX

Classification: IACT

ISOPROPYL MYRISTATEInactive

Code: 0RE8K4LNJS

Classification: IACT

CYDONIA OBLONGA SEEDInactive

Code: JXU526QH1V

Classification: IACT

ERYTHRINInactive

Code: 4TJZ1118I8

Classification: IACT

XYLITOLInactive

Code: VCQ006KQ1E

Classification: IACT

CITRUS JUNOS SEEDInactive

Code: UY43O1Q45N

Classification: IACT

ROSA ROXBURGHII FRUITInactive

Code: CVT1AA87FF

Classification: IACT

HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW)Inactive

Code: 2428CXY2LA

Classification: IACT

PERILLA FRUTESCENS LEAFInactive

Code: T4L5881Y68

Classification: IACT

POLYSILICONE-15Inactive

Code: F8DRP5BB29

Classification: IACT

BEHENYL PHOSPHATEInactive

Code: 366D9UAY69

Classification: IACT

DIISOSTEARYL MALATEInactive

Code: QBS8A3XZGQ

Classification: IACT

DISTEARDIMONIUM HECTORITEInactive

Code: X687XDK09L

Classification: IACT

ANGELICA ACUTILOBA ROOTInactive

Code: 3W51R3EK30

Classification: IACT

PEG/PPG-14/7 DIMETHYL ETHERInactive

Code: 6DNW9T7YT2

Classification: IACT

HYDROLYZED SHEEP WOOL KERATIN (200 MW)Inactive

Code: R6K7AW17SU

Classification: IACT

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)Inactive

Code: H895X08VNQ

Classification: IACT

ISOSTEARIC ACIDInactive

Code: X33R8U0062

Classification: IACT

EDETATE TRISODIUMInactive

Code: 420IP921MB

Classification: IACT

TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONEInactive

Code: X75PL53TZJ

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

ALUMINUM HYDROXIDEInactive

Code: 5QB0T2IUN0

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

CITRIC ACID ACETATEInactive

Code: DSO12WL7AU

Classification: IACT

SODIUM CITRATE, UNSPECIFIED FORMInactive

Code: 1Q73Q2JULR

Classification: IACT

TRIETHOXYCAPRYLYLSILANEInactive

Code: LDC331P08E

Classification: IACT

DIPROPYLENE GLYCOLInactive

Code: E107L85C40

Classification: IACT

TOCOPHEROLInactive

Code: R0ZB2556P8

Classification: IACT

DISODIUM STEAROYL GLUTAMATEInactive

Code: 45ASM2L11M

Classification: IACT

SODIUM METABISULFITEInactive

Code: 4VON5FNS3C

Classification: IACT

THEANINEInactive

Code: 8021PR16QO

Classification: IACT

PHENOXYETHANOLInactive

Code: HIE492ZZ3T

Classification: IACT

METHYLPARABENInactive

Code: A2I8C7HI9T

Classification: IACT

FRAGRANCE 13576Inactive

Code: 5EM498GW35

Classification: IACT

BROWN IRON OXIDEInactive

Code: 1N032N7MFO

Classification: IACT

MICAInactive

Code: V8A1AW0880

Classification: IACT

OCTINOXATEActive

Quantity: 1.715 g in 35 mL

Code: 4Y5P7MUD51

Classification: ACTIB

TITANIUM DIOXIDEActive

Quantity: 1.155 g in 35 mL

Code: 15FIX9V2JP

Classification: ACTIB

WATERInactive

Code: 059QF0KO0R

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

BUTYLENE GLYCOLInactive

Code: 3XUS85K0RA

Classification: IACT

TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)Inactive

Code: 5041RX63GN

Classification: IACT

POLYMETHYLSILSESQUIOXANE (11 MICRONS)Inactive

Code: Z570VEV8XK

Classification: IACT

ISODODECANEInactive

Code: A8289P68Y2

Classification: IACT

OCTINOXATE and TITANIUM DIOXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code58411-901

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

OCTINOXATE and TITANIUM DIOXIDE

Product Specifications

Route of AdministrationTOPICAL

Effective DateMay 21, 2025

FDA Product Classification

INGREDIENTS (54)

WATERInactive

Code: 059QF0KO0R

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

BUTYLENE GLYCOLInactive

Code: 3XUS85K0RA

Classification: IACT

TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)Inactive

Code: 5041RX63GN

Classification: IACT

POLYMETHYLSILSESQUIOXANE (11 MICRONS)Inactive

Code: Z570VEV8XK

Classification: IACT

ISODODECANEInactive

Code: A8289P68Y2

Classification: IACT

CAPRYLYL TRISILOXANEInactive

Code: Q95M2P1KJL

Classification: IACT

BIS(BUTYLAMINO)DIMETHYLSILANEInactive

Code: YG6YAQ6XCX

Classification: IACT

PEG-10 DIMETHICONE (200 CST)Inactive

Code: 287GF3Y3WC

Classification: IACT

ISOPROPYL MYRISTATEInactive

Code: 0RE8K4LNJS

Classification: IACT

MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEInactive

Code: YK3DC63Y5M

Classification: IACT

DIMETHICONE/PEG-10/15 CROSSPOLYMERInactive

Code: 21AS8B1BSS

Classification: IACT

ERYTHRINInactive

Code: 4TJZ1118I8

Classification: IACT

XYLITOLInactive

Code: VCQ006KQ1E

Classification: IACT

BARIUM SULFATEInactive

Code: 25BB7EKE2E

Classification: IACT

CYDONIA OBLONGA SEEDInactive

Code: JXU526QH1V

Classification: IACT

TREHALOSEInactive

Code: B8WCK70T7I

Classification: IACT

ARGAN OILInactive

Code: 4V59G5UW9X

Classification: IACT

GLYCINEInactive

Code: TE7660XO1C

Classification: IACT

PEG/PPG-14/7 DIMETHYL ETHERInactive

Code: 6DNW9T7YT2

Classification: IACT

CITRUS JUNOS SEEDInactive

Code: UY43O1Q45N

Classification: IACT

ROSA ROXBURGHII FRUITInactive

Code: CVT1AA87FF

Classification: IACT

ANGELICA ACUTILOBA ROOTInactive

Code: 3W51R3EK30

Classification: IACT

HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW)Inactive

Code: 2428CXY2LA

Classification: IACT

HYDROLYZED SHEEP WOOL KERATIN (200 MW)Inactive

Code: R6K7AW17SU

Classification: IACT

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)Inactive

Code: H895X08VNQ

Classification: IACT

PERILLA FRUTESCENS LEAFInactive

Code: T4L5881Y68

Classification: IACT

ISOSTEARIC ACIDInactive

Code: X33R8U0062

Classification: IACT

BEHENYL PHOSPHATEInactive

Code: 366D9UAY69

Classification: IACT

DIISOSTEARYL MALATEInactive

Code: QBS8A3XZGQ

Classification: IACT

DISTEARDIMONIUM HECTORITEInactive

Code: X687XDK09L

Classification: IACT

ALUMINUM HYDROXIDEInactive

Code: 5QB0T2IUN0

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

EDETATE TRISODIUMInactive

Code: 420IP921MB

Classification: IACT

POLYSILICONE-15Inactive

Code: F8DRP5BB29

Classification: IACT

TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONEInactive

Code: X75PL53TZJ

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

CITRIC ACID ACETATEInactive

Code: DSO12WL7AU

Classification: IACT

SODIUM CITRATE, UNSPECIFIED FORMInactive

Code: 1Q73Q2JULR

Classification: IACT

TRIETHOXYCAPRYLYLSILANEInactive

Code: LDC331P08E

Classification: IACT

DIPROPYLENE GLYCOLInactive

Code: E107L85C40

Classification: IACT

TOCOPHEROLInactive

Code: R0ZB2556P8

Classification: IACT

DISODIUM STEAROYL GLUTAMATEInactive

Code: 45ASM2L11M

Classification: IACT

SODIUM METABISULFITEInactive

Code: 4VON5FNS3C

Classification: IACT

THEANINEInactive

Code: 8021PR16QO

Classification: IACT

PHENOXYETHANOLInactive

Code: HIE492ZZ3T

Classification: IACT

METHYLPARABENInactive

Code: A2I8C7HI9T

Classification: IACT

FRAGRANCE 13576Inactive

Code: 5EM498GW35

Classification: IACT

BROWN IRON OXIDEInactive

Code: 1N032N7MFO

Classification: IACT

MICAInactive

Code: V8A1AW0880

Classification: IACT

OCTINOXATEActive

Quantity: 1.715 g in 35 mL

Code: 4Y5P7MUD51

Classification: ACTIB

TITANIUM DIOXIDEActive

Quantity: 1.155 g in 35 mL

Code: 15FIX9V2JP

Classification: ACTIB

OCTINOXATE and TITANIUM DIOXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code58411-897

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

OCTINOXATE and TITANIUM DIOXIDE

Product Specifications

Route of AdministrationTOPICAL

Effective DateMay 21, 2025

FDA Product Classification

INGREDIENTS (54)

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)Inactive

Code: 5041RX63GN

Classification: IACT

POLYMETHYLSILSESQUIOXANE (11 MICRONS)Inactive

Code: Z570VEV8XK

Classification: IACT

BIS(BUTYLAMINO)DIMETHYLSILANEInactive

Code: YG6YAQ6XCX

Classification: IACT

MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEInactive

Code: YK3DC63Y5M

Classification: IACT

ERYTHRINInactive

Code: 4TJZ1118I8

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

BUTYLENE GLYCOLInactive

Code: 3XUS85K0RA

Classification: IACT

XYLITOLInactive

Code: VCQ006KQ1E

Classification: IACT

BARIUM SULFATEInactive

Code: 25BB7EKE2E

Classification: IACT

CYDONIA OBLONGA SEEDInactive

Code: JXU526QH1V

Classification: IACT

TREHALOSEInactive

Code: B8WCK70T7I

Classification: IACT

ARGAN OILInactive

Code: 4V59G5UW9X

Classification: IACT

GLYCINEInactive

Code: TE7660XO1C

Classification: IACT

PEG/PPG-14/7 DIMETHYL ETHERInactive

Code: 6DNW9T7YT2

Classification: IACT

CITRUS JUNOS SEEDInactive

Code: UY43O1Q45N

Classification: IACT

ROSA ROXBURGHII FRUITInactive

Code: CVT1AA87FF

Classification: IACT

ANGELICA ACUTILOBA ROOTInactive

Code: 3W51R3EK30

Classification: IACT

HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW)Inactive

Code: 2428CXY2LA

Classification: IACT

HYDROLYZED SHEEP WOOL KERATIN (200 MW)Inactive

Code: R6K7AW17SU

Classification: IACT

ISODODECANEInactive

Code: A8289P68Y2

Classification: IACT

PEG-10 DIMETHICONE (200 CST)Inactive

Code: 287GF3Y3WC

Classification: IACT

CAPRYLYL TRISILOXANEInactive

Code: Q95M2P1KJL

Classification: IACT

DIMETHICONE/PEG-10/15 CROSSPOLYMERInactive

Code: 21AS8B1BSS

Classification: IACT

ISOPROPYL MYRISTATEInactive

Code: 0RE8K4LNJS

Classification: IACT

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)Inactive

Code: H895X08VNQ

Classification: IACT

PERILLA FRUTESCENS LEAFInactive

Code: T4L5881Y68

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

EDETATE TRISODIUMInactive

Code: 420IP921MB

Classification: IACT

POLYSILICONE-15Inactive

Code: F8DRP5BB29

Classification: IACT

TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONEInactive

Code: X75PL53TZJ

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

ISOSTEARIC ACIDInactive

Code: X33R8U0062

Classification: IACT

BEHENYL PHOSPHATEInactive

Code: 366D9UAY69

Classification: IACT

DIISOSTEARYL MALATEInactive

Code: QBS8A3XZGQ

Classification: IACT

DISTEARDIMONIUM HECTORITEInactive

Code: X687XDK09L

Classification: IACT

ALUMINUM HYDROXIDEInactive

Code: 5QB0T2IUN0

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

CITRIC ACID ACETATEInactive

Code: DSO12WL7AU

Classification: IACT

SODIUM CITRATE, UNSPECIFIED FORMInactive

Code: 1Q73Q2JULR

Classification: IACT

TRIETHOXYCAPRYLYLSILANEInactive

Code: LDC331P08E

Classification: IACT

DIPROPYLENE GLYCOLInactive

Code: E107L85C40

Classification: IACT

TOCOPHEROLInactive

Code: R0ZB2556P8

Classification: IACT

DISODIUM STEAROYL GLUTAMATEInactive

Code: 45ASM2L11M

Classification: IACT

SODIUM METABISULFITEInactive

Code: 4VON5FNS3C

Classification: IACT

THEANINEInactive

Code: 8021PR16QO

Classification: IACT

PHENOXYETHANOLInactive

Code: HIE492ZZ3T

Classification: IACT

METHYLPARABENInactive

Code: A2I8C7HI9T

Classification: IACT

FRAGRANCE 13576Inactive

Code: 5EM498GW35

Classification: IACT

BROWN IRON OXIDEInactive

Code: 1N032N7MFO

Classification: IACT

MICAInactive

Code: V8A1AW0880

Classification: IACT

OCTINOXATEActive

Quantity: 1.715 g in 35 mL

Code: 4Y5P7MUD51

Classification: ACTIB

TITANIUM DIOXIDEActive

Quantity: 1.155 g in 35 mL

Code: 15FIX9V2JP

Classification: ACTIB

OCTINOXATE and TITANIUM DIOXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code58411-921

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

OCTINOXATE and TITANIUM DIOXIDE

Product Specifications

Route of AdministrationTOPICAL

Effective DateMay 21, 2025

FDA Product Classification

INGREDIENTS (54)

ISOPROPYL MYRISTATEInactive

Code: 0RE8K4LNJS

Classification: IACT

DIMETHICONE/PEG-10/15 CROSSPOLYMERInactive

Code: 21AS8B1BSS

Classification: IACT

CAPRYLYL TRISILOXANEInactive

Code: Q95M2P1KJL

Classification: IACT

PEG-10 DIMETHICONE (200 CST)Inactive

Code: 287GF3Y3WC

Classification: IACT

MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEInactive

Code: YK3DC63Y5M

Classification: IACT

BIS(BUTYLAMINO)DIMETHYLSILANEInactive

Code: YG6YAQ6XCX

Classification: IACT

XYLITOLInactive

Code: VCQ006KQ1E

Classification: IACT

GLYCINEInactive

Code: TE7660XO1C

Classification: IACT

CITRUS JUNOS SEEDInactive

Code: UY43O1Q45N

Classification: IACT

ROSA ROXBURGHII FRUITInactive

Code: CVT1AA87FF

Classification: IACT

ANGELICA ACUTILOBA ROOTInactive

Code: 3W51R3EK30

Classification: IACT

HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW)Inactive

Code: 2428CXY2LA

Classification: IACT

PEG/PPG-14/7 DIMETHYL ETHERInactive

Code: 6DNW9T7YT2

Classification: IACT

HYDROLYZED SHEEP WOOL KERATIN (200 MW)Inactive

Code: R6K7AW17SU

Classification: IACT

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)Inactive

Code: H895X08VNQ

Classification: IACT

PERILLA FRUTESCENS LEAFInactive

Code: T4L5881Y68

Classification: IACT

ISOSTEARIC ACIDInactive

Code: X33R8U0062

Classification: IACT

ERYTHRINInactive

Code: 4TJZ1118I8

Classification: IACT

BARIUM SULFATEInactive

Code: 25BB7EKE2E

Classification: IACT

CYDONIA OBLONGA SEEDInactive

Code: JXU526QH1V

Classification: IACT

TREHALOSEInactive

Code: B8WCK70T7I

Classification: IACT

ARGAN OILInactive

Code: 4V59G5UW9X

Classification: IACT

BEHENYL PHOSPHATEInactive

Code: 366D9UAY69

Classification: IACT

DIISOSTEARYL MALATEInactive

Code: QBS8A3XZGQ

Classification: IACT

DISTEARDIMONIUM HECTORITEInactive

Code: X687XDK09L

Classification: IACT

ALUMINUM HYDROXIDEInactive

Code: 5QB0T2IUN0

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

EDETATE TRISODIUMInactive

Code: 420IP921MB

Classification: IACT

POLYSILICONE-15Inactive

Code: F8DRP5BB29

Classification: IACT

TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONEInactive

Code: X75PL53TZJ

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

CITRIC ACID ACETATEInactive

Code: DSO12WL7AU

Classification: IACT

SODIUM CITRATE, UNSPECIFIED FORMInactive

Code: 1Q73Q2JULR

Classification: IACT

TRIETHOXYCAPRYLYLSILANEInactive

Code: LDC331P08E

Classification: IACT

SODIUM METABISULFITEInactive

Code: 4VON5FNS3C

Classification: IACT

THEANINEInactive

Code: 8021PR16QO

Classification: IACT

PHENOXYETHANOLInactive

Code: HIE492ZZ3T

Classification: IACT

METHYLPARABENInactive

Code: A2I8C7HI9T

Classification: IACT

FRAGRANCE 13576Inactive

Code: 5EM498GW35

Classification: IACT

BROWN IRON OXIDEInactive

Code: 1N032N7MFO

Classification: IACT

MICAInactive

Code: V8A1AW0880

Classification: IACT

OCTINOXATEActive

Quantity: 1.715 g in 35 mL

Code: 4Y5P7MUD51

Classification: ACTIB

DIPROPYLENE GLYCOLInactive

Code: E107L85C40

Classification: IACT

TOCOPHEROLInactive

Code: R0ZB2556P8

Classification: IACT

DISODIUM STEAROYL GLUTAMATEInactive

Code: 45ASM2L11M

Classification: IACT

TITANIUM DIOXIDEActive

Quantity: 1.155 g in 35 mL

Code: 15FIX9V2JP

Classification: ACTIB

WATERInactive

Code: 059QF0KO0R

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

BUTYLENE GLYCOLInactive

Code: 3XUS85K0RA

Classification: IACT

TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)Inactive

Code: 5041RX63GN

Classification: IACT

POLYMETHYLSILSESQUIOXANE (11 MICRONS)Inactive

Code: Z570VEV8XK

Classification: IACT

ISODODECANEInactive

Code: A8289P68Y2

Classification: IACT

OCTINOXATE and TITANIUM DIOXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code58411-898

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

OCTINOXATE and TITANIUM DIOXIDE

Product Specifications

Route of AdministrationTOPICAL

Effective DateMay 21, 2025

FDA Product Classification

INGREDIENTS (54)

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

BUTYLENE GLYCOLInactive

Code: 3XUS85K0RA

Classification: IACT

TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)Inactive

Code: 5041RX63GN

Classification: IACT

DIMETHICONE/PEG-10/15 CROSSPOLYMERInactive

Code: 21AS8B1BSS

Classification: IACT

CYDONIA OBLONGA SEEDInactive

Code: JXU526QH1V

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

ISODODECANEInactive

Code: A8289P68Y2

Classification: IACT

CAPRYLYL TRISILOXANEInactive

Code: Q95M2P1KJL

Classification: IACT

BIS(BUTYLAMINO)DIMETHYLSILANEInactive

Code: YG6YAQ6XCX

Classification: IACT

PEG-10 DIMETHICONE (200 CST)Inactive

Code: 287GF3Y3WC

Classification: IACT

ISOPROPYL MYRISTATEInactive

Code: 0RE8K4LNJS

Classification: IACT

XYLITOLInactive

Code: VCQ006KQ1E

Classification: IACT

POLYMETHYLSILSESQUIOXANE (11 MICRONS)Inactive

Code: Z570VEV8XK

Classification: IACT

MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEInactive

Code: YK3DC63Y5M

Classification: IACT

TREHALOSEInactive

Code: B8WCK70T7I

Classification: IACT

ERYTHRINInactive

Code: 4TJZ1118I8

Classification: IACT

BARIUM SULFATEInactive

Code: 25BB7EKE2E

Classification: IACT

ARGAN OILInactive

Code: 4V59G5UW9X

Classification: IACT

CITRUS JUNOS SEEDInactive

Code: UY43O1Q45N

Classification: IACT

ROSA ROXBURGHII FRUITInactive

Code: CVT1AA87FF

Classification: IACT

ANGELICA ACUTILOBA ROOTInactive

Code: 3W51R3EK30

Classification: IACT

HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW)Inactive

Code: 2428CXY2LA

Classification: IACT

HYDROLYZED SHEEP WOOL KERATIN (200 MW)Inactive

Code: R6K7AW17SU

Classification: IACT

PERILLA FRUTESCENS LEAFInactive

Code: T4L5881Y68

Classification: IACT

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)Inactive

Code: H895X08VNQ

Classification: IACT

BEHENYL PHOSPHATEInactive

Code: 366D9UAY69

Classification: IACT

GLYCINEInactive

Code: TE7660XO1C

Classification: IACT

PEG/PPG-14/7 DIMETHYL ETHERInactive

Code: 6DNW9T7YT2

Classification: IACT

ISOSTEARIC ACIDInactive

Code: X33R8U0062

Classification: IACT

DIISOSTEARYL MALATEInactive

Code: QBS8A3XZGQ

Classification: IACT

DISTEARDIMONIUM HECTORITEInactive

Code: X687XDK09L

Classification: IACT

ALUMINUM HYDROXIDEInactive

Code: 5QB0T2IUN0

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

EDETATE TRISODIUMInactive

Code: 420IP921MB

Classification: IACT

POLYSILICONE-15Inactive

Code: F8DRP5BB29

Classification: IACT

TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONEInactive

Code: X75PL53TZJ

Classification: IACT

MICAInactive

Code: V8A1AW0880

Classification: IACT

OCTINOXATEActive

Quantity: 1.715 g in 35 mL

Code: 4Y5P7MUD51

Classification: ACTIB

TITANIUM DIOXIDEActive

Quantity: 1.155 g in 35 mL

Code: 15FIX9V2JP

Classification: ACTIB

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

CITRIC ACID ACETATEInactive

Code: DSO12WL7AU

Classification: IACT

SODIUM CITRATE, UNSPECIFIED FORMInactive

Code: 1Q73Q2JULR

Classification: IACT

TRIETHOXYCAPRYLYLSILANEInactive

Code: LDC331P08E

Classification: IACT

DIPROPYLENE GLYCOLInactive

Code: E107L85C40

Classification: IACT

TOCOPHEROLInactive

Code: R0ZB2556P8

Classification: IACT

DISODIUM STEAROYL GLUTAMATEInactive

Code: 45ASM2L11M

Classification: IACT

SODIUM METABISULFITEInactive

Code: 4VON5FNS3C

Classification: IACT

THEANINEInactive

Code: 8021PR16QO

Classification: IACT

PHENOXYETHANOLInactive

Code: HIE492ZZ3T

Classification: IACT

METHYLPARABENInactive

Code: A2I8C7HI9T

Classification: IACT

FRAGRANCE 13576Inactive

Code: 5EM498GW35

Classification: IACT

BROWN IRON OXIDEInactive

Code: 1N032N7MFO

Classification: IACT

OCTINOXATE and TITANIUM DIOXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code58411-918

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

OCTINOXATE and TITANIUM DIOXIDE

Product Specifications

Route of AdministrationTOPICAL

Effective DateMay 21, 2025

FDA Product Classification

INGREDIENTS (54)

CAPRYLYL TRISILOXANEInactive

Code: Q95M2P1KJL

Classification: IACT

BIS(BUTYLAMINO)DIMETHYLSILANEInactive

Code: YG6YAQ6XCX

Classification: IACT

PEG-10 DIMETHICONE (200 CST)Inactive

Code: 287GF3Y3WC

Classification: IACT

ISOPROPYL MYRISTATEInactive

Code: 0RE8K4LNJS

Classification: IACT

MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEInactive

Code: YK3DC63Y5M

Classification: IACT

DIMETHICONE/PEG-10/15 CROSSPOLYMERInactive

Code: 21AS8B1BSS

Classification: IACT

ROSA ROXBURGHII FRUITInactive

Code: CVT1AA87FF

Classification: IACT

ANGELICA ACUTILOBA ROOTInactive

Code: 3W51R3EK30

Classification: IACT

ERYTHRINInactive

Code: 4TJZ1118I8

Classification: IACT

XYLITOLInactive

Code: VCQ006KQ1E

Classification: IACT

BARIUM SULFATEInactive

Code: 25BB7EKE2E

Classification: IACT

CYDONIA OBLONGA SEEDInactive

Code: JXU526QH1V

Classification: IACT

TREHALOSEInactive

Code: B8WCK70T7I

Classification: IACT

GLYCINEInactive

Code: TE7660XO1C

Classification: IACT

CITRUS JUNOS SEEDInactive

Code: UY43O1Q45N

Classification: IACT

ARGAN OILInactive

Code: 4V59G5UW9X

Classification: IACT

HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW)Inactive

Code: 2428CXY2LA

Classification: IACT

PEG/PPG-14/7 DIMETHYL ETHERInactive

Code: 6DNW9T7YT2

Classification: IACT

HYDROLYZED SHEEP WOOL KERATIN (200 MW)Inactive

Code: R6K7AW17SU

Classification: IACT

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)Inactive

Code: H895X08VNQ

Classification: IACT

PERILLA FRUTESCENS LEAFInactive

Code: T4L5881Y68

Classification: IACT

ISOSTEARIC ACIDInactive

Code: X33R8U0062

Classification: IACT

BEHENYL PHOSPHATEInactive

Code: 366D9UAY69

Classification: IACT

DIISOSTEARYL MALATEInactive

Code: QBS8A3XZGQ

Classification: IACT

DISTEARDIMONIUM HECTORITEInactive

Code: X687XDK09L

Classification: IACT

ALUMINUM HYDROXIDEInactive

Code: 5QB0T2IUN0

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

DIPROPYLENE GLYCOLInactive

Code: E107L85C40

Classification: IACT

EDETATE TRISODIUMInactive

Code: 420IP921MB

Classification: IACT

POLYSILICONE-15Inactive

Code: F8DRP5BB29

Classification: IACT

TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONEInactive

Code: X75PL53TZJ

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

CITRIC ACID ACETATEInactive

Code: DSO12WL7AU

Classification: IACT

SODIUM CITRATE, UNSPECIFIED FORMInactive

Code: 1Q73Q2JULR

Classification: IACT

TRIETHOXYCAPRYLYLSILANEInactive

Code: LDC331P08E

Classification: IACT

TOCOPHEROLInactive

Code: R0ZB2556P8

Classification: IACT

DISODIUM STEAROYL GLUTAMATEInactive

Code: 45ASM2L11M

Classification: IACT

SODIUM METABISULFITEInactive

Code: 4VON5FNS3C

Classification: IACT

THEANINEInactive

Code: 8021PR16QO

Classification: IACT

PHENOXYETHANOLInactive

Code: HIE492ZZ3T

Classification: IACT

METHYLPARABENInactive

Code: A2I8C7HI9T

Classification: IACT

FRAGRANCE 13576Inactive

Code: 5EM498GW35

Classification: IACT

BROWN IRON OXIDEInactive

Code: 1N032N7MFO

Classification: IACT

TITANIUM DIOXIDEActive

Quantity: 1.155 g in 35 mL

Code: 15FIX9V2JP

Classification: ACTIB

WATERInactive

Code: 059QF0KO0R

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

BUTYLENE GLYCOLInactive

Code: 3XUS85K0RA

Classification: IACT

TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)Inactive

Code: 5041RX63GN

Classification: IACT

POLYMETHYLSILSESQUIOXANE (11 MICRONS)Inactive

Code: Z570VEV8XK

Classification: IACT

ISODODECANEInactive

Code: A8289P68Y2

Classification: IACT

MICAInactive

Code: V8A1AW0880

Classification: IACT

OCTINOXATEActive

Quantity: 1.715 g in 35 mL

Code: 4Y5P7MUD51

Classification: ACTIB

OCTINOXATE and TITANIUM DIOXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code58411-899

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

OCTINOXATE and TITANIUM DIOXIDE

Product Specifications

Route of AdministrationTOPICAL

Effective DateMay 21, 2025

FDA Product Classification

INGREDIENTS (54)

WATERInactive

Code: 059QF0KO0R

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

BUTYLENE GLYCOLInactive

Code: 3XUS85K0RA

Classification: IACT

TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)Inactive

Code: 5041RX63GN

Classification: IACT

POLYMETHYLSILSESQUIOXANE (11 MICRONS)Inactive

Code: Z570VEV8XK

Classification: IACT

CAPRYLYL TRISILOXANEInactive

Code: Q95M2P1KJL

Classification: IACT

BIS(BUTYLAMINO)DIMETHYLSILANEInactive

Code: YG6YAQ6XCX

Classification: IACT

ISODODECANEInactive

Code: A8289P68Y2

Classification: IACT

PEG-10 DIMETHICONE (200 CST)Inactive

Code: 287GF3Y3WC

Classification: IACT

MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEInactive

Code: YK3DC63Y5M

Classification: IACT

ISOPROPYL MYRISTATEInactive

Code: 0RE8K4LNJS

Classification: IACT

DIMETHICONE/PEG-10/15 CROSSPOLYMERInactive

Code: 21AS8B1BSS

Classification: IACT

ERYTHRINInactive

Code: 4TJZ1118I8

Classification: IACT

BARIUM SULFATEInactive

Code: 25BB7EKE2E

Classification: IACT

XYLITOLInactive

Code: VCQ006KQ1E

Classification: IACT

CYDONIA OBLONGA SEEDInactive

Code: JXU526QH1V

Classification: IACT

TREHALOSEInactive

Code: B8WCK70T7I

Classification: IACT

ARGAN OILInactive

Code: 4V59G5UW9X

Classification: IACT

GLYCINEInactive

Code: TE7660XO1C

Classification: IACT

PEG/PPG-14/7 DIMETHYL ETHERInactive

Code: 6DNW9T7YT2

Classification: IACT

CITRUS JUNOS SEEDInactive

Code: UY43O1Q45N

Classification: IACT

ROSA ROXBURGHII FRUITInactive

Code: CVT1AA87FF

Classification: IACT

ANGELICA ACUTILOBA ROOTInactive

Code: 3W51R3EK30

Classification: IACT

HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW)Inactive

Code: 2428CXY2LA

Classification: IACT

HYDROLYZED SHEEP WOOL KERATIN (200 MW)Inactive

Code: R6K7AW17SU

Classification: IACT

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)Inactive

Code: H895X08VNQ

Classification: IACT

PERILLA FRUTESCENS LEAFInactive

Code: T4L5881Y68

Classification: IACT

ISOSTEARIC ACIDInactive

Code: X33R8U0062

Classification: IACT

BEHENYL PHOSPHATEInactive

Code: 366D9UAY69

Classification: IACT

DIISOSTEARYL MALATEInactive

Code: QBS8A3XZGQ

Classification: IACT

DISTEARDIMONIUM HECTORITEInactive

Code: X687XDK09L

Classification: IACT

ALUMINUM HYDROXIDEInactive

Code: 5QB0T2IUN0

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

EDETATE TRISODIUMInactive

Code: 420IP921MB

Classification: IACT

POLYSILICONE-15Inactive

Code: F8DRP5BB29

Classification: IACT

TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONEInactive

Code: X75PL53TZJ

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

CITRIC ACID ACETATEInactive

Code: DSO12WL7AU

Classification: IACT

SODIUM CITRATE, UNSPECIFIED FORMInactive

Code: 1Q73Q2JULR

Classification: IACT

TRIETHOXYCAPRYLYLSILANEInactive

Code: LDC331P08E

Classification: IACT

DIPROPYLENE GLYCOLInactive

Code: E107L85C40

Classification: IACT

TOCOPHEROLInactive

Code: R0ZB2556P8

Classification: IACT

DISODIUM STEAROYL GLUTAMATEInactive

Code: 45ASM2L11M

Classification: IACT

SODIUM METABISULFITEInactive

Code: 4VON5FNS3C

Classification: IACT

THEANINEInactive

Code: 8021PR16QO

Classification: IACT

PHENOXYETHANOLInactive

Code: HIE492ZZ3T

Classification: IACT

METHYLPARABENInactive

Code: A2I8C7HI9T

Classification: IACT

FRAGRANCE 13576Inactive

Code: 5EM498GW35

Classification: IACT

BROWN IRON OXIDEInactive

Code: 1N032N7MFO

Classification: IACT

MICAInactive

Code: V8A1AW0880

Classification: IACT

OCTINOXATEActive

Quantity: 1.715 g in 35 mL

Code: 4Y5P7MUD51

Classification: ACTIB

TITANIUM DIOXIDEActive

Quantity: 1.155 g in 35 mL

Code: 15FIX9V2JP

Classification: ACTIB

OCTINOXATE and TITANIUM DIOXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code58411-911

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

OCTINOXATE and TITANIUM DIOXIDE

Product Specifications

Route of AdministrationTOPICAL

Effective DateMay 21, 2025

FDA Product Classification

INGREDIENTS (54)

BIS(BUTYLAMINO)DIMETHYLSILANEInactive

Code: YG6YAQ6XCX

Classification: IACT

CAPRYLYL TRISILOXANEInactive

Code: Q95M2P1KJL

Classification: IACT

PEG-10 DIMETHICONE (200 CST)Inactive

Code: 287GF3Y3WC

Classification: IACT

MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEInactive

Code: YK3DC63Y5M

Classification: IACT

ISOPROPYL MYRISTATEInactive

Code: 0RE8K4LNJS

Classification: IACT

BARIUM SULFATEInactive

Code: 25BB7EKE2E

Classification: IACT

DIMETHICONE/PEG-10/15 CROSSPOLYMERInactive

Code: 21AS8B1BSS

Classification: IACT

ERYTHRINInactive

Code: 4TJZ1118I8

Classification: IACT

XYLITOLInactive

Code: VCQ006KQ1E

Classification: IACT

CYDONIA OBLONGA SEEDInactive

Code: JXU526QH1V

Classification: IACT

TREHALOSEInactive

Code: B8WCK70T7I

Classification: IACT

ARGAN OILInactive

Code: 4V59G5UW9X

Classification: IACT

GLYCINEInactive

Code: TE7660XO1C

Classification: IACT

CITRUS JUNOS SEEDInactive

Code: UY43O1Q45N

Classification: IACT

ROSA ROXBURGHII FRUITInactive

Code: CVT1AA87FF

Classification: IACT

ANGELICA ACUTILOBA ROOTInactive

Code: 3W51R3EK30

Classification: IACT

HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW)Inactive

Code: 2428CXY2LA

Classification: IACT

PEG/PPG-14/7 DIMETHYL ETHERInactive

Code: 6DNW9T7YT2

Classification: IACT

HYDROLYZED SHEEP WOOL KERATIN (200 MW)Inactive

Code: R6K7AW17SU

Classification: IACT

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)Inactive

Code: H895X08VNQ

Classification: IACT

PERILLA FRUTESCENS LEAFInactive

Code: T4L5881Y68

Classification: IACT

ISOSTEARIC ACIDInactive

Code: X33R8U0062

Classification: IACT

BEHENYL PHOSPHATEInactive

Code: 366D9UAY69

Classification: IACT

DIISOSTEARYL MALATEInactive

Code: QBS8A3XZGQ

Classification: IACT

DISTEARDIMONIUM HECTORITEInactive

Code: X687XDK09L

Classification: IACT

SODIUM CITRATE, UNSPECIFIED FORMInactive

Code: 1Q73Q2JULR

Classification: IACT

TRIETHOXYCAPRYLYLSILANEInactive

Code: LDC331P08E

Classification: IACT

DIPROPYLENE GLYCOLInactive

Code: E107L85C40

Classification: IACT

TOCOPHEROLInactive

Code: R0ZB2556P8

Classification: IACT

DISODIUM STEAROYL GLUTAMATEInactive

Code: 45ASM2L11M

Classification: IACT

SODIUM METABISULFITEInactive

Code: 4VON5FNS3C

Classification: IACT

THEANINEInactive

Code: 8021PR16QO

Classification: IACT

PHENOXYETHANOLInactive

Code: HIE492ZZ3T

Classification: IACT

METHYLPARABENInactive

Code: A2I8C7HI9T

Classification: IACT

FRAGRANCE 13576Inactive

Code: 5EM498GW35

Classification: IACT

BROWN IRON OXIDEInactive

Code: 1N032N7MFO

Classification: IACT

MICAInactive

Code: V8A1AW0880

Classification: IACT

OCTINOXATEActive

Quantity: 1.715 g in 35 mL

Code: 4Y5P7MUD51

Classification: ACTIB

TITANIUM DIOXIDEActive

Quantity: 1.155 g in 35 mL

Code: 15FIX9V2JP

Classification: ACTIB

ALUMINUM HYDROXIDEInactive

Code: 5QB0T2IUN0

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

EDETATE TRISODIUMInactive

Code: 420IP921MB

Classification: IACT

POLYSILICONE-15Inactive

Code: F8DRP5BB29

Classification: IACT

TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONEInactive

Code: X75PL53TZJ

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

CITRIC ACID ACETATEInactive

Code: DSO12WL7AU

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

BUTYLENE GLYCOLInactive

Code: 3XUS85K0RA

Classification: IACT

TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)Inactive

Code: 5041RX63GN

Classification: IACT

POLYMETHYLSILSESQUIOXANE (11 MICRONS)Inactive

Code: Z570VEV8XK

Classification: IACT

ISODODECANEInactive

Code: A8289P68Y2

Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/21/2025

PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - O70

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
NATURAL

BROAD SPECTRUM
SPF 25
SUNSCREEN

35mL 1.1 FL. OZ.

Principal Display Panel - 35 mL Vial Carton - O70

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/20/2025

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 3/20/2025

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/20/2025

Active ingredients	Purpose
OCTINOXATE 4.9%	Sunscreen
TITANIUM DIOXIDE 3.3%	Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 3/20/2025

Warnings

For external use only

Do not useon damaged or broken skin

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

Stop use and ask a doctorif rash occurs

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 3/20/2025

Directions

For sunscreen use:

apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
reapply 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 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-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 3/20/2025

Inactive Ingredients

WATER･DIMETHICONE･GLYCERIN･BUTYLENE GLYCOL･TRIMETHYLSILOXYSILICATE･POLYMETHYLSILSESQUIOXANE･ISODODECANE･CAPRYLYL METHICONE･BIS-BUTYLDIMETHICONE POLYGLYCERYL-3･PEG-10 DIMETHICONE･ISOPROPYL MYRISTATE･SYNTHETIC FLUORPHLOGOPITE･DIMETHICONE/PEG-10/15 CROSSPOLYMER･ERYTHRITOL･XYLITOL･BARIUM SULFATE･PYRUS CYDONIA SEED EXTRACT･TREHALOSE･ARGANIA SPINOSA KERNEL OIL･GLYCINE･PEG/PPG-14/7 DIMETHYL ETHER･CITRUS JUNOS SEED EXTRACT･ROSA ROXBURGHII FRUIT EXTRACT･ANGELICA ACUTILOBA ROOT EXTRACT･HYDROLYZED CONCHIOLIN PROTEIN･HYDROLYZED SILK･DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER･PERILLA OCYMOIDES LEAF EXTRACT･ISOSTEARIC ACID･BIS-BEHENYL/PHYTOSTERYL DIMER DILINOLEATE･DIISOSTEARYL MALATE･DISTEARDIMONIUM HECTORITE･ALUMINUM HYDROXIDE･STEARIC ACID･TRISODIUM EDTA･POLYSILICONE-2･TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE･BHT･ALCOHOL･CITRIC ACID･SODIUM CITRATE･TRIETHOXYCAPRYLYLSILANE･DIPROPYLENE GLYCOL･TOCOPHEROL･DISODIUM STEAROYL GLUTAMATE･SODIUM METABISULFITE･THEANINE･PHENOXYETHANOL･METHYLPARABEN･FRAGRANCE･TITANIUM DIOXIDE･IRON OXIDES･MICA･

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 3/20/2025

Other information

protect this product in this container from excessive heat and direct sun.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 3/20/2025

Questions or Comments?

Call toll free 1-800-906-7503

AI-Powered Research

Premium Access

cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL

Products 10

OCTINOXATE and TITANIUM DIOXIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (54)

OCTINOXATE and TITANIUM DIOXIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (54)

OCTINOXATE and TITANIUM DIOXIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (54)

OCTINOXATE and TITANIUM DIOXIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (54)

OCTINOXATE and TITANIUM DIOXIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (54)

OCTINOXATE and TITANIUM DIOXIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (54)

OCTINOXATE and TITANIUM DIOXIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (54)

OCTINOXATE and TITANIUM DIOXIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (54)

OCTINOXATE and TITANIUM DIOXIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (54)

OCTINOXATE and TITANIUM DIOXIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (54)

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - O70

INDICATIONS & USAGE SECTION

Uses

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

WARNINGS SECTION

Warnings

DOSAGE & ADMINISTRATION SECTION

Directions

INACTIVE INGREDIENT SECTION

Inactive Ingredients

STORAGE AND HANDLING SECTION

Other information

OTC - QUESTIONS SECTION