FATAZEN BEAUTIHOOD Whitening Sunscreen by Guangzhou Guocui Biological Technology Co., Ltd / Guangzhou Guocui Biological Technology Co Ltd

FATAZEN BEAUTIHOOD Whitening Sunscreen by

Drug Labeling and Warnings

FATAZEN BEAUTIHOOD Whitening Sunscreen by is a Otc medication manufactured, distributed, or labeled by Guangzhou Guocui Biological Technology Co., Ltd, Guangzhou Guocui Biological Technology Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FATAZEN BEAUTIHOOD WHITENING SUNSCREEN- fatazen beautihood whitening sunscreen cream 
Guangzhou Guocui Biological Technology Co., Ltd

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OCTOCRYLENE 10%------------------------------------SUNSCREEN
BUTYL METHOXYDIBENZOYLMETHANE 4%------ SSUNSCREEN
ETHYLHEXYL SALICYLATE 4 %-----------------------SUNSCREEN
METHYLENE BIS-BENZOTRIAZOLYL
TETRAMETHYLBUTYLPHENOL 3%------------------SUNSCREEN
TITANIUM DIOXIDE 2 %---------------------------------SUNSCREEN
DIMETHICONE 2 %---------------------------------------SKIN PROTECTANT
PHENYLBENZIMIDAZOLE SULFONIC ACID 2 %----SUNSCREEN

SUNSCREEN

Sun protection, UV protection,
sunburn protection

For external use only

in children less than 2 months of age
on open skin wounds

When using this product keep out of eyes, ears, and
mouth. In case of contact with eyes, rinse eyes
thoroughly with water.Stop use and ask a doctor if
irritation or rash occurs. These may be signs of a
serious condition.Keep out of reach of children. If
swallowed, get medical help or contact a Poison
Control Center right away.

Keep out of reach of children. swallowed, get medical elp or contact a Poison ControlCenter right away.

Stop use and ask a doctor if irritation or rash occurs.
These may be signs of a serious condition.

Before going out, take an appropriate amount of thisproduct and apply
it on your skin, then spread it evenly on your face. Apply once every 4-6 hours.
Please supervise children under 6 years old to avoid swallowing when using
this product.Storage temperature is 15-30C (59-86F)

Store between 15-30C ( 59-86F )

Dioctyl carbonate, potassium cetyl phosphate, water, decyl glucoside, propylene
glycol, xanthan gum, cetearyl alcohol, silica, dimethicone, butylene glycol,
glycerin, behenyl alcohol , Tromethamine, Dimethicone, Silica, Polyglyceryl-10
Decearate, Polyhydroxystearic Acid, Panthenol, Tocopheryl Acetate, Xanthan Gum,
Allantoin, Parahydroxy Acetophenone, 1,2-hexanediol, acrylicacid (ester)/C10-30
alkanol acrylate crosspolymer, EDTA disodium, (daily) fragrance, superoxide
dismutase (SOD), yeast Bacterial fermentation products, lactic acid bacteria
fermentation products, yogurt extract, butylene glycol, p-hydroxyacetophenone,
1,2-hexanediol

FATAZEN BEAUTIHOOD WHITENING SUNSCREEN 
fatazen beautihood whitening sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83885-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	2 g  in 100 g
BISOCTRIZOLE (UNII: 8NT850T0YS) (BISOCTRIZOLE - UNII:8NT850T0YS)	BISOCTRIZOLE	4 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
XANTHAN GUM (UNII: TTV12P4NEE)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYGLYCERYL-10 DECAOLEATE (UNII: NJR3XZA3NW)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PANTHENOL (UNII: WV9CM0O67Z)
ALLANTOIN (UNII: 344S277G0Z)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
WATER (UNII: 059QF0KO0R)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83885-003-01	30 g in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2024	02/14/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/31/2024	02/14/2025

Labeler - Guangzhou Guocui Biological Technology Co., Ltd (419547269)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Guocui Biological Technology Co Ltd		419547269	manufacture(83885-003)

Revised: 2/2025

Document Id: 2e166d78-b142-aadf-e063-6394a90acfba

34390-5

Set id: 14ec1591-c404-b714-e063-6294a90afa76

Version: 2

Effective Time: 20250214

 

Guangzh