Sunforgettable Total Protection Body Shield Bronze
Sunforgettable Total Protection Body Shield Bronze
Approved
Approval ID
cea44748-935b-2493-e053-2995a90a012d
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 Code68078-044
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 (33)
ISOHEXADECANEInactive
Code: 918X1OUF1E
Classification: IACT
PROPYLENE CARBONATEInactive
Code: 8D08K3S51E
Classification: IACT
PHENYLPROPANOLInactive
Code: 0F897O3O4M
Classification: IACT
METHYLPROPANEDIOLInactive
Code: N8F53B3R4R
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)Inactive
Code: UDR641JW8W
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
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
TRILAURETH-4 PHOSPHATEInactive
Code: M96W2OLL2V
Classification: IACT
ISODODECANEInactive
Code: A8289P68Y2
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
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TREMELLA FUCIFORMIS FRUITING BODYInactive
Code: GG8N28393G
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
ALKYL (C12-15) BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATESInactive
Code: 0K5Y9U1P6M
Classification: IACT
PHYSALIS ANGULATAInactive
Code: W4TKW9D5GG
Classification: IACT
POLYMETHYLSILSESQUIOXANE (11 MICRONS)Inactive
Code: Z570VEV8XK
Classification: IACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATEInactive
Code: 9229XJ4V12
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
TETRASODIUM GLUTAMATE DIACETATEInactive
Code: 5EHL50I4MY
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ISOCETETH-10Inactive
Code: 1K92T9919H
Classification: IACT
DISTEARDIMONIUM HECTORITEInactive
Code: X687XDK09L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MICAInactive
Code: V8A1AW0880
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 6/2/2021
Sunforgettable Total Protection Body Shield Bronze
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 6/2/2021
SFTP Body Shield Bronze
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 6/2/2021
SFTP Body Shield Bronze
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 6/2/2021
SFTP Body Shield Bronze
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 6/2/2021
SFTP Body Shield Bronze
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 6/2/2021
SFTP Body Shield Bronze
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 6/2/2021
SFTP Body Shield Bronze
WARNINGS SECTION
LOINC: 34071-1Updated: 6/2/2021
SFTP Body Shield Bronze