MedPath

Reduce Lip Lines

Approved
Approval ID

37fce9e6-adae-af3c-e063-6394a90a140b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 20, 2025

Manufacturers
FDA

Guangzhou Yapeng Refinement Chemical Co., Ltd.

DUNS: 529423510

Products 1

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

Lip Repair Mask

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84356-007
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Lip Repair Mask
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 20, 2025
FDA Product Classification

INGREDIENTS (12)

CHAMOMILEInactive
Code: FGL3685T2X
Classification: IACT
ALOE VERA LEAF JUICEActive
Quantity: 13 g in 100 g
Code: RUE8E6T4NB
Classification: ACTIB
COCONUT OILInactive
Code: Q9L0O73W7L
Classification: IACT
HYALURONIC ACIDInactive
Code: S270N0TRQY
Classification: IACT
GRAPE SEED EXTRACTInactive
Code: RDS2V6DVY5
Classification: IACT
ROSA CANINA SEED OILInactive
Code: MHT97MG5P8
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
MENTHOLActive
Quantity: 0.4 g in 100 g
Code: L7T10EIP3A
Classification: ACTIB
CANDELILLA WAXInactive
Code: WL0328HX19
Classification: IACT
JOJOBA OILInactive
Code: 724GKU717M
Classification: IACT
CINNAMON OILInactive
Code: E5GY4I6YCZ
Classification: IACT
VANILLAInactive
Code: Q74T35078H
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/20/2025

PXCKAGE LABEL

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/20/2025

Reduce Lip Lines
Relieve & Repair
Increase Elasticity
Lip Plumping
Brightening

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/20/2025

ACTIVE INGEREDIENT SECTION

Menthol (from Peppermint Oil) 0.4%

Aloe Vera Gel 13%

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/20/2025

Candelilla Wax, Coconut Oil, Chamomile Extract, Cinnamon Oil, ROSA CANINA SEED OIL, Hyaluronic Acid, Jojoba Oil, Tocopherol, Vanilla Extract, Grapeseed Extract

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/20/2025

Temporarily relieves pain from chapped lips,Forms a protective barrier to heal dry/cracked lips,Enhances lip elasticity and reduces visible wrinkles,Brightens lip tone and evens pigmentation

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/20/2025

If ingested, contact Poison Control Center

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 6/20/2025

If allergic to mint, cinnamon, or botanical oils

On bleeding or infected lip areas

In children under 2 years

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 6/20/2025

Avoid contact with eyes. If contact occurs, rinse thoroughly with water
Discontinue if burning sensation persists over 10 minutes
Not for ingestion. If swallowed, seek medical help immediately

WARNINGS SECTION

LOINC: 34071-1Updated: 6/20/2025

If allergic to mint, cinnamon, or botanical oils,On bleeding or infected lip areas,In children under 2 years

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/20/2025

Apply thin layer to clean lips using fingertip Gently massage for 30 seconds to enhance absorption Use up to 4 times daily, preferably at bedtime For overnight repair: Apply thick layer before sleep

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 6/20/2025

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 6/20/2025

Keep tightly closed at 15-30°C (59-86°F). Avoid heat above 40°C (104°F) and direct sunlight.

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Reduce Lip Lines - FDA Drug Approval Details