Aspen Islanders Sheer Mineral Sport
Aspen Islanders Sheer Mineral Sport
Approved
Approval ID
0fcb2adf-71c9-3369-e063-6294a90aa806
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Aug 27, 2025
Manufacturers
FDA
Aspen Islanders LLC
DUNS: 081541038
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 Code83382-1005
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Zinc Oxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 27, 2025
FDA Product Classification
INGREDIENTS (24)
COCO-CAPRYLATEInactive
Code: 4828G836N6
Classification: IACT
ISOPROPYL ISOSTEARATEInactive
Code: C67IXB9Y7T
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
ZINC OXIDEActive
Quantity: 132 mg in 1 mL
Code: SOI2LOH54Z
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYESTER-7Inactive
Code: 0841698D2F
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
ALKYL (C12-15) BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
VITIS VINIFERA SEEDInactive
Code: C34U15ICXA
Classification: IACT
NEOPENTYL GLYCOL DIHEPTANOATEInactive
Code: 5LKW3C543X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TRIDECYL SALICYLATEInactive
Code: AZQ08K38Z1
Classification: IACT
SIMMONDSIA CHINENSIS SEEDInactive
Code: D24K2Q1F6H
Classification: IACT
PROPANEDIOLInactive
Code: 5965N8W85T
Classification: IACT
.ALPHA.-BISABOLOL, (+)-Inactive
Code: 105S6I733Z
Classification: IACT
PHENYLPROPANOLInactive
Code: 0F897O3O4M
Classification: IACT
SQUALANEInactive
Code: GW89575KF9
Classification: IACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATEInactive
Code: 9229XJ4V12
Classification: IACT
ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TRIBEHENINInactive
Code: 8OC9U7TQZ0
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 12/15/2023
Aspen Islanders Sheer Mineral Sport
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 12/15/2023
Aspen Islanders Sheer Mineral Sport
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 12/15/2023
Aspen Islanders Sheer Mineral Sport
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 12/15/2023
Aspen Islanders Sheer Mineral Sport
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 12/15/2023
Aspen Islanders Sheer Mineral Sport
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 12/15/2023
Aspen Islanders Sheer Mineral Sport
WARNINGS SECTION
LOINC: 34071-1Updated: 12/15/2023
Aspen Islanders Sheer Mineral Sport
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 12/15/2023
Aspen Islanders Sheer Mineral Sport
