MedPath

Super lightening Based on gold 24k and kojic acid Cream

Approved
Approval ID

36148dd7-a0e2-0143-e063-6394a90a5069

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 26, 2025

Manufacturers
FDA

Guangzhou Kadiya Biotechnology Co., Ltd.

DUNS: 713172913

Products 1

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

Super lightening Based on gold 24k and kojic acid Cream

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84423-080
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Super lightening Based on gold 24k and kojic acid Cream
Product Specifications
Route of AdministrationCUTANEOUS
Effective DateMay 26, 2025
FDA Product Classification

INGREDIENTS (27)

CI 19140Inactive
Code: I753WB2F1M
Classification: IACT
PAPAYAActive
Quantity: 1 g in 50 g
Code: KU94FIY6JB
Classification: ACTIB
GLYCERYL STEARATEInactive
Code: 230OU9XXE4
Classification: IACT
TRIETHANOLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
MYRISTIC ACIDInactive
Code: 0I3V7S25AW
Classification: IACT
LAURIC ACIDInactive
Code: 1160N9NU9U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PALMITIC ACIDInactive
Code: 2V16EO95H1
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ALUMINAInactive
Code: LMI26O6933
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PEG-60 SORBITAN STEARATEInactive
Code: 073G38N8GC
Classification: IACT
PEG-75 LANOLINInactive
Code: 09179OX7TB
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CETYLPYRIDINIUM BROMIDEInactive
Code: O77BKZ14DE
Classification: IACT
ALPHA-ARBUTINInactive
Code: 72VUP07IT5
Classification: IACT
NIACINAMIDEInactive
Code: 25X51I8RD4
Classification: IACT
ETHOXYDIGLYCOLInactive
Code: A1A1I8X02B
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT
NUTMEGInactive
Code: AEE24M3MQ9
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CI 15985Inactive
Code: H77VEI93A8
Classification: IACT
STEAROLIC ACIDInactive
Code: 7M9KFA3WKU
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/25/2025

Active Ingredients
CARICA PAPAYA FRUIT EXTRACT

Uses:
For Facial Skin Moisturizing, Antioxidant, Blemish Removal, Whitening, Brightening
The storage method:
Store sealed in a cool place and out of sunlight

Warning.
1.Before use, perform a skin test on your arm and discontinue use if you have allergy symptoms or skin abnormalities.
2、For external use only, avoid contact with eyes when used
3、Keep out of reach of children

Inactive ingredients:
AQUA,MINERAL OIL,GLYCERIN,Polyethylene,PROPYLENE GLYCOL,STEARYL ALCOHOL,BUTYLENE GLYCOL,Steareth-2,Steareth-21,CETYL ALCOHOL,DIMETHICONE,Isosorbide Dimethyl Ether,GLYCERYL STEARATE,PEG-100,PHENOXYETHANOL,ALLANTOIN,Polyacrylamide,ALOE BARBADENSIS LEAF EXTRACT,ANTHEMIS NOBILIS FLOWER EXTRACT,PORTULACA OLERACEA FLOWER/LEAF/STEM EXTRACT,PELARGONIUM GRAVEOLENS FLOWER/LEAF/STEM EXTRACT,XANTHAN GUM,FRAGRANCE,ETHYLHEXYLGLYCERIN, C13-14 Isoparaffin,DISODIUM EDTA,Laureth-7

Papaya Face Cream

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/27/2025

Wash vour face with water, applvan appropriate amount ofcream to the face, gently massage until absorbed.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/27/2025

For Facial Skin Moisturizing, Antioxidant, Blemish Removal, Whitening, Brightening

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/27/2025

AQUA,MINERAL OIL,GLYCERIN,Polyethylene,PROPYLENE GLYCOL,STEARYL ALCOHOL,BUTYLENE GLYCOL,Steareth-2,Steareth-21,CETYL ALCOHOL,DIMETHICONE,Isosorbide Dimethyl Ether,GLYCERYL STEARATE,PEG-100,PHENOXYETHANOL,ALLANTOIN,Polyacrylamide,ALOE BARBADENSIS LEAF EXTRACT,ANTHEMIS NOBILIS FLOWER EXTRACT,PORTULACA OLERACEA FLOWER/LEAF/STEM EXTRACT,PELARGONIUM GRAVEOLENS FLOWER/LEAF/STEM EXTRACT,XANTHAN GUM,FRAGRANCE,ETHYLHEXYLGLYCERIN, C13-14 Isoparaffin,DISODIUM EDTA,Laureth-7

WARNINGS SECTION

LOINC: 34071-1Updated: 5/27/2025

1.Before use, perform a skin test on your arm and discontinue use if you have allergy symptoms or skin abnormalities.

2、For external use only, avoid contact with eyes when used

3、Keep out of reach of children

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/27/2025

Gently apply a little bit with your hands, and then spread it evenly.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/27/2025

KEEP OUT OF REACH OF CHILDREN SECTION

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/27/2025

CARICA PAPAYA FRUIT EXTRACT

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Super lightening Based on gold 24k and kojic acid Cream - FDA Drug Approval Details