LIGHTENING SUNCREEN CREAM emulsion

Lightening Suncreen Cream by

Drug Labeling and Warnings

Lightening Suncreen Cream 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：
Helps prevent sunburn
Indications: For sun protection

INACTIVE INGREDIENT

AQUA、MINERAL OIL、GLYCERIN、CETEARYL ALCOHOL、UREA、DIMETHICONE、GLYCERYL STEARATE、CETEARETH-20、POTASSIUM CETYL PHOSPHATE、PEG-100 STEARATE、TRIETHANOLAMINE、ALLANTOIN、CARBOMER、C13-16 ISOALKANE、DMDM HYDANTOIN、AROMA、METHYLPARABEN、PROPYLPARABEN、3-O-ETHYL ASCORBIC ACID、DISODIUM EDTA、BUTYLENE GLYCOL、IODOPROPYNYL BUTYLCARBAMATE、CI 19140

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

Step 1 Take an appropriate
amount in the palm.
Step 2 Spread evenly on
the face, neck and body.
Step 3 Evenly pat around
the skin and push away,
waiting to be absorbed.
1. Use daily during the day,
after any daytime skin care
products, and before
makeup.
2. Use it 15 minutes before
going out.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN SECTION

ACTIVE INGREDIENT

Active Ingredients
NIACINAMIDE 1mg
Zinc oxide 6%

DOSAGE & ADMINISTRATION

1. Use daily during the day,
after any daytime skin care
products, and before
makeup.
2. Use it 15 minutes before
going out.

PRINCIPAL DISPLAY PANEL

Active Ingredients
NIACINAMIDE 1mg
Zinc oxide 6%

Uses：
Helps prevent sunburn
Indications: For sun protection

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、DIMETHICONE、GLYCERYL STEARATE、CETEARETH-20、POTASSIUM CETYL PHOSPHATE、PEG-100 STEARATE、TRIETHANOLAMINE、ALLANTOIN、CARBOMER、C13-16 ISOALKANE、DMDM HYDANTOIN、AROMA、METHYLPARABEN、PROPYLPARABEN、3-O-ETHYL ASCORBIC ACID、DISODIUM EDTA、BUTYLENE GLYCOL、IODOPROPYNYL BUTYLCARBAMATE、CI 19140

INGREDIENTS AND APPEARANCE

LIGHTENING SUNCREEN CREAM 
lightening suncreen cream emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84423-010
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	0.5 mg  in 50 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3 mg  in 50 mg

Inactive Ingredients
Ingredient Name	Strength
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
MINERAL OIL (UNII: T5L8T28FGP)
DIMETHICONE (UNII: 92RU3N3Y1O)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
UREA (UNII: 8W8T17847W)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALLANTOIN (UNII: 344S277G0Z)
3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-100 STEARATE (UNII: YD01N1999R)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84423-010-01	50 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/08/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	07/08/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Kadiya Biotechnology Co., Ltd.		713172913	manufacture(84423-010)