Label: FATAZEN BEAUTIHOOD WHITENING SUNSCREEN cream

  • NDC Code(s): 83885-003-01
  • Packager: Guangzhou Guocui Biological Technology Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 31, 2024

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  • ACTIVE INGREDIENT

    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

  • PURPOSE

    SUNSCREEN

  • INDICATIONS & USAGE

    Sun protection, UV protection,
    sunburn protection

  • WARNINGS

    For external use only

  • DO NOT USE

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

  • WHEN USING

    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

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

  • STOP USE

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

  • DOSAGE & ADMINISTRATION

    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)

  • STORAGE AND HANDLING

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

  • INACTIVE INGREDIENT

    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

  • PRINCIPAL DISPLAY PANEL

    83885-003-01

  • INGREDIENTS AND APPEARANCE
    FATAZEN BEAUTIHOOD WHITENING SUNSCREEN 
    fatazen beautihood whitening sunscreen cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83885-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISOCTRIZOLE (UNII: 8NT850T0YS) (BISOCTRIZOLE - UNII:8NT850T0YS) BISOCTRIZOLE4 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2 g  in 100 g
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 g
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE2 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83885-003-0130 g in 1 BOTTLE; Type 0: Not a Combination Product03/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/31/2024
    Labeler - Guangzhou Guocui Biological Technology Co., Ltd (419547269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Guocui Biological Technology Co Ltd419547269manufacture(83885-003)
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