Sunforgettable Total Protection Face Shield Glow
Sunforgettable Total Protection Face Shield Glow
Approved
Approval ID
cdb5397a-c463-4b41-e053-2a95a90a9e03
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 Code68078-041
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Zinc Oxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 13, 2025
FDA Product Classification
INGREDIENTS (31)
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATESInactive
Code: 0K5Y9U1P6M
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DIMETHYLMETHOXY CHROMANOLInactive
Code: XBH432G01F
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)Inactive
Code: 9E4CO0W6C5
Classification: IACT
ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT
TRILAURETH-4 PHOSPHATEInactive
Code: M96W2OLL2V
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
ISODODECANEInactive
Code: A8289P68Y2
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
DEHYDROACETIC ACIDInactive
Code: 2KAG279R6R
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
HELIANTHUS ANNUUS SPROUTInactive
Code: 4P26HG1S5W
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
CAESALPINIA SPINOSA FRUIT PODInactive
Code: EXY4496LWD
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
MICAInactive
Code: V8A1AW0880
Classification: IACT
NIACINAMIDEInactive
Code: 25X51I8RD4
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
HEXYLENE GLYCOLInactive
Code: KEH0A3F75J
Classification: IACT
ALKYL (C12-15) BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW)Inactive
Code: 9KB5R958PB
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
.ALPHA.-BISABOLOL, (+)-Inactive
Code: 105S6I733Z
Classification: IACT
TRIDECYL SALICYLATEInactive
Code: AZQ08K38Z1
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 6/27/2021
Sunforgettable Total Protection Face Shield Glow
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 6/27/2021
Sunforgettable Total Protection Face Shield Glow
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 6/27/2021
Sunforgettable Total Protection Face Shield Glow
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 6/27/2021
Sunforgettable Total Protection Face Shield Glow
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 6/27/2021
Sunforgettable Total Protection Face Shield Glow
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 6/27/2021
Sunforgettable Total Protection Face Shield Glow
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 6/27/2021
Sunforgettable Total Protection Face Shield Glow
WARNINGS SECTION
LOINC: 34071-1Updated: 6/27/2021
Sunforgettable Total Protection Face Shield Glow