Sunforgettable Total Protection Face Shield Flex

Approved

Approval ID

cdb55347-aedd-4de6-e053-2a95a90afec7

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 13, 2025

Manufacturers

FDA

Colorescience

DUNS: 128731929

Products 1

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

Zinc Oxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code68078-042

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

Zinc Oxide

Product Specifications

Route of AdministrationTOPICAL

Effective DateAugust 13, 2025

FDA Product Classification

INGREDIENTS (37)

SODIUM MYRISTOYL GLUTAMATEInactive

Code: AYU7QD893W

Classification: IACT

TRIDECYL SALICYLATEInactive

Code: AZQ08K38Z1

Classification: IACT

DIMETHYLMETHOXY CHROMANOLInactive

Code: XBH432G01F

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

CAPRYLYL GLYCOLInactive

Code: 00YIU5438U

Classification: IACT

MYRISTYL TRISILOXANEInactive

Code: J7960S4R1T

Classification: IACT

LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONEInactive

Code: 25G622K2RA

Classification: IACT

ALLANTOINInactive

Code: 344S277G0Z

Classification: IACT

.ALPHA.-BISABOLOL, (+)-Inactive

Code: 105S6I733Z

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)Inactive

Code: 9E4CO0W6C5

Classification: IACT

TRILAURETH-4 PHOSPHATEInactive

Code: M96W2OLL2V

Classification: IACT

BUTYLOCTYL SALICYLATEInactive

Code: 2EH13UN8D3

Classification: IACT

ISODODECANEInactive

Code: A8289P68Y2

Classification: IACT

NIACINAMIDEInactive

Code: 25X51I8RD4

Classification: IACT

ZINC OXIDEActive

Quantity: 135.6 mg in 1 mL

Code: SOI2LOH54Z

Classification: ACTIB

WATERInactive

Code: 059QF0KO0R

Classification: IACT

DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW)Inactive

Code: 9KB5R958PB

Classification: IACT

ETHYLHEXYLGLYCERINInactive

Code: 147D247K3P

Classification: IACT

HEXYLENE GLYCOLInactive

Code: KEH0A3F75J

Classification: IACT

DEHYDROACETIC ACIDInactive

Code: 2KAG279R6R

Classification: IACT

PROPANEDIOLInactive

Code: 5965N8W85T

Classification: IACT

TETRASODIUM GLUTAMATE DIACETATEInactive

Code: 5EHL50I4MY

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

PHENOXYETHANOLInactive

Code: HIE492ZZ3T

Classification: IACT

TREMELLA FUCIFORMIS FRUITING BODYInactive

Code: GG8N28393G

Classification: IACT

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

ALKYL (C12-15) BENZOATEInactive

Code: A9EJ3J61HQ

Classification: IACT

DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATESInactive

Code: 0K5Y9U1P6M

Classification: IACT

ISOCETETH-10Inactive

Code: 1K92T9919H

Classification: IACT

CAESALPINIA SPINOSA FRUIT PODInactive

Code: EXY4496LWD

Classification: IACT

HELIANTHUS ANNUUS SPROUTInactive

Code: 4P26HG1S5W

Classification: IACT

MICAInactive

Code: V8A1AW0880

Classification: IACT

SILICA DIMETHYL SILYLATEInactive

Code: EU2PSP0G0W

Classification: IACT

ZEINInactive

Code: 80N308T1NN

Classification: IACT

ALUMINUM HYDROXIDEInactive

Code: 5QB0T2IUN0

Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/6/2021

Sunforgettable Total Protection Face Shield Flex

![PDP](/dailymed/image.cfm?name=CS- FaceShield+FLEX_UnitCarton_1709723R1_PRINT+%281%29.jpg&id=892717)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/6/2021

SFTP Face Shield Flex

![Indications & usage](/dailymed/image.cfm?name=CS- FaceShield+FLEX_UnitCarton_1709723R1_PRINT+%281%29.jpg&id=892717)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/6/2021

SFTP Face Shield Flex

![purpose](/dailymed/image.cfm?name=CS- FaceShield+FLEX_UnitCarton_1709723R1_PRINT+%281%29.jpg&id=892717)

WARNINGS SECTION

LOINC: 34071-1Updated: 5/6/2021

SFTP Face Shield Flex

![Warning Label](/dailymed/image.cfm?name=CS- FaceShield+FLEX_UnitCarton_1709723R1_PRINT+%281%29.jpg&id=892717)

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/6/2021

SFTP Face Shield Flex

![Active Ingredients](/dailymed/image.cfm?name=CS- FaceShield+FLEX_UnitCarton_1709723R1_PRINT+%281%29.jpg&id=892717)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/6/2021

SFTP Face Shield Flex

![keep out of reach of children](/dailymed/image.cfm?name=CS- FaceShield+FLEX_UnitCarton_1709723R1_PRINT+%281%29.jpg&id=892717)

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/6/2021

SFTP Face Shield Flex

![Dosage and Administration](/dailymed/image.cfm?name=CS- FaceShield+FLEX_UnitCarton_1709723R1_PRINT+%281%29.jpg&id=892717)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/6/2021

SFTP Face Shield Flex

![Inactive ingredients](/dailymed/image.cfm?name=CS- FaceShield+FLEX_UnitCarton_1709723R1_PRINT+%281%29.jpg&id=892717)

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Sunforgettable Total Protection Face Shield Flex

Products 1

Zinc Oxide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (37)

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sunforgettable Total Protection Face Shield Flex

INDICATIONS & USAGE SECTION

SFTP Face Shield Flex

OTC - PURPOSE SECTION

SFTP Face Shield Flex

WARNINGS SECTION

SFTP Face Shield Flex

OTC - ACTIVE INGREDIENT SECTION

SFTP Face Shield Flex

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

SFTP Face Shield Flex

DOSAGE & ADMINISTRATION SECTION

SFTP Face Shield Flex

INACTIVE INGREDIENT SECTION

SFTP Face Shield Flex

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