OrgaPlus Super Care Balm for combination and oi ly skin type

Manufacturer
BLUEZONWIDE CO.,LTD | Cosmax, Inc.
Effective date
2025-02-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:54:23

Label at a glance#

ProductOrgaPlus Super Care Balm for combination and oi ly skin type 20g
Active ingredientSUNFLOWER OIL
Label structure9 sections

Indications and uses

Uses: Helps prevent and relieve skin dryness.

Dosage and administration

Directions: 01. Remove the protective cap and extend the stick outward slightly, apply directly to the face and body. 02. Gently pat to fully absorb into skin.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Helianthus Annuus (Sunflower) Seed Oil 56.59%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Beeswax, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Theobroma Grandiflorum Seed Butter, Citrus Aurantium Dulcis (Orange) Peel Oil, Tocopherol, Orbignya Oleifera Seed Oil, Persea Gratissima (Avocado) Oil, Rubus Chamaemorus Seed Oil, Rubus Idaeus (Raspberry) Seed Oil, Butylene Glycol, Propolis Extract

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin moisturizing

WARNINGS

WARNINGS SECTION

Warnings:

-For external use only

-Protect the product in the container from excessive heat and direct sun light.

-When using this product keep out of eyes.

-Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Uses

INDICATIONS & USAGE SECTION

Uses:

Helps prevent and relieve skin dryness.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:

01. Remove the protective cap and extend the stick outward slightly, apply directly to the face and body.

02. Gently pat to fully absorb into skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69777-190-022025-02-05C16284748780-12cef2736-8390-d83d-e063-dadaa90ab31f676e4d9f-62bc-4983-81fe-0d314ef46874
69777-190-022025-01-30C16284748780-12cef2736-8390-d83d-e063-dadaa90ab31f676e4d9f-62bc-4983-81fe-0d314ef46874

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69777-190-01OrgaPlus Super Care Balm for combination and oi ly skin type20g20 g in 1 CONTAINERSTICK202
69777-190-02OrgaPlus Super Care Balm for combination and oi ly skin type20g1 in 1 CARTONSTICK12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69777-190ORGAPLUS SUPER CARE BALM FOR COMBINATION AND OI LY SKIN TYPE 20G (SUNFLOWER) STICK [BLUEZONWIDE CO.,LTD]2Current NDC, Legacy NDC, 2 package rows20250206_676e4d9f-62bc-4983-81fe-0d314ef46874.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69777-19069777-190-01, 69777-190-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
APIS MELLIFERA7S82P3R43ZIACT
ORANGE OILAKN3KSD11BIACT
SUNFLOWER OIL3W1JG795YIACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OrgaPlus Super Care Balm for combination and oi ly skin type 20gSUNFLOWERBLUEZONWIDE CO.,LTD676e4d9f-62bc-4983-81fe-0d314ef468742025-02-05WarningsExact identifier
ndc (package): 69777-190-01
ndc (package): 69777-190-02
ndc (product): 69777-190
ndc11 (package): 69777019001
ndc11 (package): 69777019002
spl id: 2d5fef46-0c05-5058-e063-6294a90a06c1
spl set id: 676e4d9f-62bc-4983-81fe-0d314ef46874

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.