BRIGHTENING BODYLOTION- brightening body lotion emulsion

Brightening BodyLotion by

Drug Labeling and Warnings

Brightening BodyLotion by is a Otc medication manufactured, distributed, or labeled by Guangzhou Kadiya Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Uses：
For Skin Whitening

INACTIVE INGREDIENT

AQUA、MINERAL OIL、GLYCERIN、CETEARYL ALCOHOL、UREA、GLYCERYL STEARATE、PEG-100 STEARATE、CETEARETH-20、POTASSIUM CETYL PHOSPHATE、C13-16 ISOPARAFFIN、DIMETHICONE、DMDM HYDANTOIN、BUTYLENE GLYCOL、IODOPROPYNYL BUTYLCARBAMATE、AROMA、METHYLPARABEN、CARBOMER、ALLANTOIN、TRIETHANOLAMINE、PROPYLPARABEN、DISODIUM EDTA、3-o-ETHYL ASCORBIC ACID

WARNINGS

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

INDICATIONS & USAGE

Direction : Apply liberally all over the body twice daily after bathing.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN SECTION

ACTIVE INGREDIENT

Active Ingredients
ALPHA-ARBUTIN0.5%
KOJIC DIPALMITATE0.5%
NIACINAMIDE 3%

DOSAGE & ADMINISTRATION

Apply liberally all over the body twice daily after bathing.

PRINCIPAL DISPLAY PANEL

Drug Facts
Active Ingredients
ALPHA-ARBUTIN0.5%
KOJIC DIPALMITATE0.5%
NIACINAMIDE 3%

Uses：
For Skin Whitening
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、CETEARYL ALCOHOL、UREA、GLYCERYL STEARATE、PEG-100 STEARATE、CETEARETH-20、POTASSIUM CETYL PHOSPHATE、C13-16 ISOPARAFFIN、DIMETHICONE、DMDM HYDANTOIN、BUTYLENE GLYCOL、IODOPROPYNYL BUTYLCARBAMATE、AROMA、METHYLPARABEN、CARBOMER、ALLANTOIN、TRIETHANOLAMINE、PROPYLPARABEN、DISODIUM EDTA、3-o-ETHYL ASCORBIC ACID

INGREDIENTS AND APPEARANCE

BRIGHTENING BODYLOTION 
brightening body lotion emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84423-030
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	9 mg  in 300 mL
ALPHA-ARBUTIN (UNII: 72VUP07IT5) (ALPHA-ARBUTIN - UNII:72VUP07IT5)	ALPHA-ARBUTIN	1.5 mg  in 300 mL
KOJIC DIPALMITATE (UNII: 13N249RWTM) (KOJIC DIPALMITATE - UNII:13N249RWTM)	KOJIC DIPALMITATE	1.5 mg  in 300 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
METHYLPARABEN (UNII: A2I8C7HI9T)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
UREA (UNII: 8W8T17847W)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PEG-100 STEARATE (UNII: YD01N1999R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84423-030-01	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/25/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	07/25/2024

Labeler - Guangzhou Kadiya Biotechnology Co., Ltd. (713172913)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Kadiya Biotechnology Co., Ltd.		713172913	manufacture(84423-030)