MedPath

ODLUMIVIE Tremella Revitalizing Cleanser

Approved
Approval ID

3cdf06f2-63f2-7a59-e063-6294a90a72ea

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 3, 2025

Manufacturers
FDA

Guangzhou Meijiao Medical Biotechnology Co., Ltd.

DUNS: 978211825

Products 1

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

TREMELLA FUCIFORMIS WHOLE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code87036-021
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
TREMELLA FUCIFORMIS WHOLE
Product Specifications
Route of AdministrationCUTANEOUS
Effective DateSeptember 3, 2025
FDA Product Classification

INGREDIENTS (12)

ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCINE MAX (SOYBEAN) OILInactive
Code: 241ATL177A
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM LAUROAMPHOACETATEInactive
Code: SLK428451L
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
TREMELLA FUCIFORMIS WHOLEActive
Quantity: 1 g in 100 mL
Code: 4938BNS0GU
Classification: ACTIB
SODIUM COCOYL ALANINATEInactive
Code: 7M2ZN582ZV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
COCO-GLUCOSIDEInactive
Code: ICS790225B
Classification: IACT
PANTHENOLInactive
Code: WV9CM0O67Z
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/2/2025

USAGE
ODLUMIVIE
DERMA-BEAUTY
Cleansing
Softening
IIAIWATGO
LH9I NMO HNOX HLIM 3NIHS人InV38-VW830
After wetting your face with lukewarm waterdispense an adequate amount into your palm.Gently massage over the skin to release the richsilky foam,allowing Tremella Fuciformis extract,fermented soybean actives,and revitalizingpeptides to deeply cleanse while preservingmoisture,Rinse thoroughly and pat dry.Usemorning and evening for a refreshed,
comfortable complexion.
INGREDIENTSTremella Fuciformis Extract,Water(Aqua)Sodium CocoylAlaninate,Glycerin,Coco-Glucoside,Cocamidopropyl Betaine,Panthenol,Sodium Lauroamphoacetate,GlycineMax(Soybean)Polypeptide,Allantoin,Bacillus/Soybean Ferment Extract, SodiumChloride, Citric Acid, Silver
KEY BENEFITS
Gently cleanse and revitalize your skin with thisluxurious amino acid facial cleanser,powered byTremella Fuciformis extract for deep hydration,panthenol and allantoin to soothe and repair,bio-active soybean peptides and fermentedactives to boost radiance, and silver to helppurify and protect. The rich, silky foam lifts awayimpurities without stripping moisture, leavingyour complexion soft,refreshed, andhealthy-looking after every wash.
CAUTIONFor external use only. Avoid directcontact with eyes.Ifirritation occurs,stop useand consult a doctor ifneeded.Patch test recommended.
Do not use ifyou are allergic to any ofthe
Smoothing
ingredients.
Keep out ofreach ofchildren.
555

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/2/2025

USAGE
After wetting your face with lukewarm water,dispense an adequate amount into your palm.Gently massage over the skin to release the rich,silky foam, allowing Tremella Fuciformis extract,fermented soybean actives, and revitalizingpeptides to deeply cleanse while preservingmoisture. Rinse thoroughly and pat dry. Usemorning and evening for a refreshed,comfortable complexion.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/2/2025

ACTIVE INGREDIENT

WARNINGS SECTION

LOINC: 34071-1Updated: 9/2/2025

CAUTION
For external use only, Avoid direct contact with eyes. Ifirritation occurs, stop useand consult a doctor if needed. Patch test recommended, Do not use if you areallergic to any of the ingredients. Keep out of reach of children.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/2/2025

CAUTION
For external use only, Avoid direct contact with eyes. Ifirritation occurs, stop useand consult a doctor if needed. Patch test recommended, Do not use if you areallergic to any of the ingredients. Keep out of reach of children.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/2/2025

INGREDIENTS
Tremella Fuciformis Extract, Water (Aqua),Sodium Cocoyl Alaninate, Glycerin,Coco-Glucoside, Cocamidopropyl Betaine,Panthenol, Sodium Lauroamphoacetate, GlycineMax (Soybean) Polypeptide, Allantoin,Bacillus/Soybean Ferment Extract, SodiumChloride, Citric Acid, Silver

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/2/2025

KEY BENEFITSGently cleanse and revitalize your skin with thisluxurious amino acid facial cleanser, powered byTremella Fuciformis extract for deep hydration,panthenol and allantoin to soothe and repair,bio-active soybean peptides and fermentedactives to boost radiance, and silver to helppurify and protect. The rich, silky foam lifts awayimpurities without stripping moisture, leavingyour complexion soft, refreshed, andhealthy-looking after every wash.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/2/2025

CAUTION
For external use only, Avoid direct contact with eyes. Ifirritation occurs, stop useand consult a doctor if needed. Patch test recommended, Do not use if you areallergic to any of the ingredients. Keep out of reach of children.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/2/2025

CAUTION
For external use only, Avoid direct contact with eyes. Ifirritation occurs, stop useand consult a doctor if needed. Patch test recommended, Do not use if you areallergic to any of the ingredients. Keep out of reach of children.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/2/2025

USAGE
After wetting your face with lukewarm water,dispense an adequate amount into your palm.Gently massage over the skin to release the rich,silky foam, allowing Tremella Fuciformis extract,fermented soybean actives, and revitalizingpeptides to deeply cleanse while preservingmoisture. Rinse thoroughly and pat dry. Usemorning and evening for a refreshed,comfortable complexion.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/2/2025

USAGE
After wetting your face with lukewarm water,dispense an adequate amount into your palm.Gently massage over the skin to release the rich,silky foam, allowing Tremella Fuciformis extract,fermented soybean actives, and revitalizingpeptides to deeply cleanse while preservingmoisture. Rinse thoroughly and pat dry. Usemorning and evening for a refreshed,comfortable complexion.

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 9/2/2025

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ODLUMIVIE Tremella Revitalizing Cleanser - FDA Drug Approval Details