Sunforgettable Total Protection Color Balm (Blush)
Sunforgettable Total Protection Color Balm (Blush)
Approved
Approval ID
9f2f7133-1c93-8441-e053-2995a90ab09a
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 Code68078-034
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 (19)
.ALPHA.-BISABOLOL, (+/-)-Inactive
Code: 36HQN158VC
Classification: IACT
MICAInactive
Code: V8A1AW0880
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
VINYLPYRROLIDONE/EICOSENE COPOLYMERInactive
Code: 035MV9S1C3
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)Inactive
Code: 59Z907ZB69
Classification: IACT
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW)Inactive
Code: 9KB5R958PB
Classification: IACT
DIMETHYLMETHOXY CHROMANOLInactive
Code: XBH432G01F
Classification: IACT
TRIDECYL SALICYLATEInactive
Code: AZQ08K38Z1
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
SQUALANEInactive
Code: GW89575KF9
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ZINC OXIDEActive
Quantity: 125 mg in 1 g
Code: SOI2LOH54Z
Classification: ACTIB
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
METHYLPROPANEDIOLInactive
Code: N8F53B3R4R
Classification: IACT
PHENYLPROPANOLInactive
Code: 0F897O3O4M
Classification: IACT
C18-36 ACID TRIGLYCERIDEInactive
Code: ZRA72DR3R7
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 1/15/2020
Sunforgettable Total Protection Color Balm (Blush)
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 1/15/2020
Sunforgettable Total Protection Color Balm (Blush)
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 1/15/2020
Sunforgettable Total Protection Color Balm (Blush)
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 1/15/2020
Sunforgettable Total Protection Color Balm (Blush)
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 1/15/2020
Sunforgettable Total Protection Color Balm (Blush)
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 1/15/2020
Sunforgettable Total Protection Color Balm (Blush)
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 1/15/2020
Sunforgettable Total Protection Color Balm (Blush)
WARNINGS SECTION
LOINC: 34071-1Updated: 1/15/2020
Sunforgettable Total Protection Color Balm (Blush)