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dAlba Vegan Fresh Sun Cushion

d'Alba Vegan Fresh Sun Cushion

Approved
Approval ID

20afcbab-a2f4-7965-e063-6294a90a83d1

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 8, 2025

Manufacturers
FDA

ADMTMAX LLC

DUNS: 101826554

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Zinc Oxide, Homosalate, Octocrylene

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84662-060
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Zinc Oxide, Homosalate, Octocrylene
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 8, 2025
FDA Product Classification

INGREDIENTS (2)

GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ZINC OXIDEActive
Quantity: 11.58 mg in 25 g
Code: SOI2LOH54Z
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/27/2024

Main Display

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/27/2024

indication

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/27/2024

dosage

WARNINGS SECTION

LOINC: 34071-1Updated: 8/27/2024

warning

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/27/2024

inactive ingredients

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/27/2024

children out

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/27/2024

purpose

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/27/2024

active ing

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dAlba Vegan Fresh Sun Cushion - FDA Drug Approval Details