Baby Bare Republic Mineral Sunscreen
Baby Bare Republic Mineral Sunscreen
Approved
Approval ID
b292d1a9-7ff8-0faf-e053-2995a90ae342
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Aug 27, 2025
Manufacturers
FDA
COOLA, LLC
DUNS: 956990290
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 Code79753-007
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 (28)
ZINC OXIDEActive
Quantity: 12 mg in 1 mL
Code: SOI2LOH54Z
Classification: ACTIB
SQUALANEInactive
Code: GW89575KF9
Classification: IACT
PROPANEDIOLInactive
Code: 5965N8W85T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYGLYCERYL-3 RICINOLEATEInactive
Code: MZQ63P0N0W
Classification: IACT
.ALPHA.-BISABOLOL, (-)-EPI-Inactive
Code: 37VB7WIC8L
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
TRIDECYL SALICYLATEInactive
Code: AZQ08K38Z1
Classification: IACT
ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
NEOPENTYL GLYCOL DIHEPTANOATEInactive
Code: 5LKW3C543X
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POLYESTER-7Inactive
Code: 0841698D2F
Classification: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
ISODECYL SALICYLATEInactive
Code: S7097PFP4C
Classification: IACT
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLESInactive
Code: XO45V955LT
Classification: IACT
ISOPROPYL ISOSTEARATEInactive
Code: C67IXB9Y7T
Classification: IACT
1,2-HEXANEDIOLInactive
Code: TR046Y3K1G
Classification: IACT
ALKYL (C12-15) BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW)Inactive
Code: 9KB5R958PB
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
ISOSTEARIC ACIDInactive
Code: X33R8U0062
Classification: IACT
CALENDULA OFFICINALIS FLOWERInactive
Code: P0M7O4Y7YD
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
TRIBEHENINInactive
Code: 8OC9U7TQZ0
Classification: IACT
GLYCERYL STEARATE CITRATEInactive
Code: WH8T92A065
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 10/26/2020
Baby Bare Republic Mineral Sunscreen
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 10/26/2020
Baby Bare Republic Mineral Sunscreen
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 10/26/2020
Baby Bare Republic Mineral Sunscreen
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 10/26/2020
Baby Bare Republic Mineral Sunscreen
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 10/26/2024
Baby Bare Republic Mineral Sunscreen
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 10/26/2020
Baby Bare Republic Mineral Sunscreen
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 10/26/2020
Baby Bare Republic Mineral Sunscreen
WARNINGS SECTION
LOINC: 34071-1Updated: 10/26/2020
Baby Bare Republic Mineral Sunscreen