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YVTYVT DARK SPOT

Approved
Approval ID

352699fa-f746-c931-e063-6394a90a6391

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 15, 2025

Manufacturers
FDA

Beijing JUNGE Technology Co., Ltd.

DUNS: 848718652

Products 1

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

DARK SPOT

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85212-0040
Application NumberANDA075357
Product Classification
M
Marketing Category
C73584
G
Generic Name
DARK SPOT
Product Specifications
Route of AdministrationEXTRACORPOREAL
Effective DateMay 15, 2025
FDA Product Classification

INGREDIENTS (21)

CETEARYL GLUCOSIDEInactive
Quantity: 1 mL in 100 mL
Code: 09FUA47KNA
Classification: IACT
GLYCERYL CAPRYLATEInactive
Quantity: 0.1 mL in 100 mL
Code: TM2TZD4G4A
Classification: IACT
METHYLPARABENInactive
Quantity: 0.1 mL in 100 mL
Code: A2I8C7HI9T
Classification: IACT
PANTHENOLInactive
Quantity: 0.5 mL in 100 mL
Code: WV9CM0O67Z
Classification: IACT
SODIUM HYALURONATEInactive
Quantity: 0.5 mL in 100 mL
Code: YSE9PPT4TH
Classification: IACT
PROPYLENE GLYCOL 2-HEXANOATEInactive
Quantity: 0.1 mL in 100 mL
Code: 39RQR15921
Classification: IACT
BIOSACCHARIDE GUM-2Inactive
Quantity: 1 mL in 100 mL
Code: UVQ34I5XKQ
Classification: IACT
WATERInactive
Quantity: 78.6 mL in 100 mL
Code: 059QF0KO0R
Classification: IACT
BISABOLOLInactive
Quantity: 0.5 mL in 100 mL
Code: 24WE03BX2T
Classification: IACT
KOJIC ACIDActive
Quantity: 1 g in 100 mL
Code: 6K23F1TT52
Classification: ACTIB
ASCORBIC ACIDActive
Quantity: 2 g in 100 mL
Code: PQ6CK8PD0R
Classification: ACTIB
4-BUTYLRESORCINOLInactive
Quantity: 2 mL in 100 mL
Code: 2IK4UQ3ZGA
Classification: IACT
1,2-HEXANEDIOLInactive
Quantity: 0.5 mL in 100 mL
Code: TR046Y3K1G
Classification: IACT
CAMELLIA JAPONICA SEED OILInactive
Quantity: 1 mL in 100 mL
Code: U37N0S910T
Classification: IACT
NIACINAMIDEInactive
Quantity: 1 mL in 100 mL
Code: 25X51I8RD4
Classification: IACT
BUTYLENE GLYCOLInactive
Quantity: 5 mL in 100 mL
Code: 3XUS85K0RA
Classification: IACT
CETEARYL ALCOHOLInactive
Quantity: 1 mL in 100 mL
Code: 2DMT128M1S
Classification: IACT
BETAINEInactive
Quantity: 2 mL in 100 mL
Code: 3SCV180C9W
Classification: IACT
XANTHAN GUMInactive
Quantity: 0.1 mL in 100 mL
Code: TTV12P4NEE
Classification: IACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OILInactive
Quantity: 1 mL in 100 mL
Code: 724GKU717M
Classification: IACT
GLUTATHIONEInactive
Quantity: 1 mL in 100 mL
Code: GAN16C9B8O
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/1/2025

YVTYVT Dark Spot REMOVER

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/1/2025

Used to remove dark spots
Reduce pigmentation
For skin moisturizing

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 1/1/2025

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/1/2025

For best results, use daily for 2-4 weeks

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 1/1/2025

Step 1: Cleanse skin to remove impurities.
Step 2: Apply appropriate amount post - cleansing.
Step 3: Use before heavy moisturizers or oils for better absorption.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 1/1/2025

If the product gets into your eyes, rinse immediately with plenty of water.
Discontinue Use if Irritation Occurs: If redness, itching, or irritation develops, stop use and consult a dermatologist.

OTC - DO NOT USE SECTION

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

Do Not Apply on Broken or Irritated Skin.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/1/2025

ASCORBIC ACID, KOJIC ACID

ALARMS

LOINC: 69761-5Updated: 1/1/2025

For External Use Only.
Avoid Direct Contact with Eyes. If the product gets into your eyes, rinse immediately with plenty of water.
Discontinue Use if Irritation Occurs: If redness, itching, or irritation develops, stop use and consult a dermatologist.
Use Sunscreen: Always use sunscreen during the day while using this product, as some ingredients may increase sensitivity to sunlight.
Do Not Apply on Broken or Irritated Skin.
Keep Out of Reach of Children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/1/2025

WATER
BUTYLENE GLYCOL
BETAINE
4-BUTYLRESORCINOL
GLUTATHIONE
NIACINAMIDE
CAMELLIA JAPONICA SEED OIL
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL
CETEARYL ALCOHOL
CETEARYL GLUCOSIDE
BIOSACCHARIDE GUM-2
PANTHENOL
BISABOLOL
1,2-HEXANEDIOL
SODIUM HYALURONATE
XANTHAN GUM
PROPYLENE GLYCOL
METHYLPARABEN
GLYCERYL CAPRYLATE

WARNINGS SECTION

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

For External Use Only.
Avoid Direct Contact with Eyes.
If the product gets into your eyes, rinse immediately with plenty of water.
Discontinue Use if Irritation Occurs: If redness, itching, or irritation develops, stop use and consult a dermatologist.
Do Not Apply on Broken or Irritated Skin. Keep Out of Reach of Children.

OTC - PURPOSE SECTION

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

Used to remove dark spots

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YVTYVT DARK SPOT - FDA Drug Approval Details