Sunforgettable Total Protection Face Shield Matte

Approved

Approval ID

cd879b3e-16a2-2cca-e053-2a95a90a14f8

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 Code68078-038

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

Zinc Oxide

Product Specifications

Route of AdministrationTOPICAL

Effective DateAugust 13, 2025

FDA Product Classification

INGREDIENTS (30)

BUTYLENE GLYCOLInactive

Code: 3XUS85K0RA

Classification: IACT

DECYL GLUCOSIDEInactive

Code: Z17H97EA6Y

Classification: IACT

HEXYLENE GLYCOLInactive

Code: KEH0A3F75J

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

TRIDECYL SALICYLATEInactive

Code: AZQ08K38Z1

Classification: IACT

DIMETHYLMETHOXY CHROMANOLInactive

Code: XBH432G01F

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

NIACINAMIDEInactive

Code: 25X51I8RD4

Classification: IACT

ZINC OXIDEActive

Quantity: 135.6 mg in 1 mL

Code: SOI2LOH54Z

Classification: ACTIB

SODIUM HYDROXIDEInactive

Code: 55X04QC32I

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW)Inactive

Code: 9KB5R958PB

Classification: IACT

ETHYLHEXYLGLYCERINInactive

Code: 147D247K3P

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

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/17/2021

Sunforgettable Total Protection Face Shield Matte

![PDP](/dailymed/image.cfm?name=CS- FaceShield+MATTE_UnitCarton_1709601R1_PRINT+%281%29.jpg&id=892714)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/17/2021

Sunforgettable Total Protection Face Shield Matte

![Indications & usage](/dailymed/image.cfm?name=CS- FaceShield+MATTE_UnitCarton_1709601R1_PRINT+%281%29.jpg&id=892714)

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/17/2021

Sunforgettable Total Protection Face Shield Matte

![Dosage and Administration](/dailymed/image.cfm?name=CS- FaceShield+MATTE_UnitCarton_1709601R1_PRINT+%281%29.jpg&id=892714)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/17/2021

Sunforgettable Total Protection Face Shield Matte

![Inactive ingredients](/dailymed/image.cfm?name=CS- FaceShield+MATTE_UnitCarton_1709601R1_PRINT+%281%29.jpg&id=892714)

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/17/2021

Sunforgettable Total Protection Face Shield Matte

![Active Ingredients](/dailymed/image.cfm?name=CS- FaceShield+MATTE_UnitCarton_1709601R1_PRINT+%281%29.jpg&id=892714)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/17/2021

Sunforgettable Total Protection Face Shield Matte

![keep out of reach of children](/dailymed/image.cfm?name=CS- FaceShield+MATTE_UnitCarton_1709601R1_PRINT+%281%29.jpg&id=892714)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/17/2021

Sunforgettable Total Protection Face Shield Matte

![purpose](/dailymed/image.cfm?name=CS- FaceShield+MATTE_UnitCarton_1709601R1_PRINT+%281%29.jpg&id=892714)

WARNINGS SECTION

LOINC: 34071-1Updated: 5/17/2021

Sunforgettable Total Protection Face Shield Matte

![Warning Label](/dailymed/image.cfm?name=CS- FaceShield+MATTE_UnitCarton_1709601R1_PRINT+%281%29.jpg&id=892714)

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Sunforgettable Total Protection Face Shield Matte

Products 1

Zinc Oxide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (30)

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sunforgettable Total Protection Face Shield Matte

INDICATIONS & USAGE SECTION

Sunforgettable Total Protection Face Shield Matte

DOSAGE & ADMINISTRATION SECTION

Sunforgettable Total Protection Face Shield Matte

INACTIVE INGREDIENT SECTION

Sunforgettable Total Protection Face Shield Matte

OTC - ACTIVE INGREDIENT SECTION

Sunforgettable Total Protection Face Shield Matte

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Sunforgettable Total Protection Face Shield Matte

OTC - PURPOSE SECTION

Sunforgettable Total Protection Face Shield Matte

WARNINGS SECTION

Sunforgettable Total Protection Face Shield Matte

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