Label: SUNSCREEN CREAM- avobenzone , homosalate ,octisalate , octocrylene lotion, augmented

  • NDC Code(s): 84445-005-01
  • Packager: Shenzhen Furuizhilian keji Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 16, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Avobenzone 3%, Homosalate 6%,Octisalate 5%, Octocrylene 5%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Helps prevent sunburn
    if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • WARNINGS

    For external use only

  • STOP USE

    rash occurs

  • DO NOT USE

    on damaged or broken skin

  • WHEN USING

    keep out of eyes. Rinse with water to remone

  • KEEP OUT OF REACH OF CHILDREN

    If product is swallowed, get medical help or contact a Poison Control Center right away. May stain some fabrics.

  • INACTIVE INGREDIENT

    Water, Ethylhexyl Methoxycinnamate, Butylene Glycol, Ethylhexyl Salicylate, Phenylbenzimidazole Sulfonic Acid, Cetearyl Alcohol, Dicaprylyl Carbonate, Diethylhexyl Butamido Triazone, Titanium Dioxide, C20-22 Alkyl Phosphate, Aluminum Starch Octenylsuccinate, C20-22 Alcohols, Arginine, Pentylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Sodium Stearoyl Glutamate, Sodium Hydroxide, Hydroxyacetophenone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Squalane, Silica, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Allantoin, Caprylyl Glycol, Tocopherol (Vitamin E), Stearyl Glycyrrhetinate, Polysorbate 60, Disodium EDTA, Fragrance, Sorbitan Isostearate, BHT, Caprylic/Capric Triglyceride, Theobroma Cacao (Cocoa) Seed Extract, Glucose, Potassium Sorbate

  • DOSAGE & ADMINISTRATION

    Use when going out

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN CREAM 
    avobenzone , homosalate ,octisalate , octocrylene lotion, augmented
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84445-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 50 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3 g  in 50 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 g  in 50 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.5 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    C20-22 ALCOHOLS (UNII: O4M0347C6A)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S AT 1.0%) (UNII: 8Z5ZAL5H3V)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BEMOTRIZINOL (UNII: PWZ1720CBH)  
    ARGININE (UNII: 94ZLA3W45F)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    COCOA (UNII: D9108TZ9KG)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ISCOTRIZINOL (UNII: 2UTZ0QC864)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    OCTINOXATE (UNII: 4Y5P7MUD51)  
    ENSULIZOLE (UNII: 9YQ9DI1W42)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALLANTOIN (UNII: 344S277G0Z)  
    FRAGRANCE 13576 (UNII: 5EM498GW35)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SQUALANE (UNII: GW89575KF9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84445-005-0150 g in 1 TUBE; Type 0: Not a Combination Product07/16/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/16/2024
    Labeler - Shenzhen Furuizhilian keji Co., Ltd. (418598613)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Furuizhilian keji Co., Ltd.418598613manufacture(84445-005)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!