Label: SOLFUL FACE SUNLOTION- homosalate, avobenzone, otisalate, octocrylene lotion

  • NDC Code(s): 83918-001-01, 83918-001-02
  • Packager: KARA BEAUTY INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 28, 2023

If you are a consumer or patient please visit this version.

  • PURPOSE

    Sunscreen

  • ACTIVE INGREDIENT

    Homosalate 10%, Octocrylene 5%, Octisalate 4%, Avobenzone 3%

  • INDICATIONS & USAGE

    Helps prevent sunburn

  • DOSAGE & ADMINISTRATION

    Apply liberally 15 minutes before sun exposure. Reapply at least every two hours
    Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
    Ask a doctor to use for children under 6 months

  • WARNINGS

    For external use only.

    Do not use on damaged or broken skin

    When using this product, keep out of eyes. Rinse with water to remove.

    Stop using and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

  • INACTIVE INGREDIENT

    Water, Dipropylene Glycol, Silica, Diphenylsiloxy Phenyl Trimethicone, Isohexadecane, Butyloctyl Salicylate, Polysorbate 80, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Benzyl Glycol, Glyceryl Stearate, PEG-100 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Xanthan Gum, Centella Asiatica Extract, Butylene Glycol, Ethylhexylglycerin, Propanediol, Bambusa Vulgaris Leaf Extract, Oldenlandia Diffusa Extract, Sodium Hyaluronate Crosspolymer, Lonicera Caprifolium (Honeysuckle) Extract, 1,2-Hexanediol, Hydrolyzed Glycosaminoglycans, Yeast Extract, Limonia Acidissima Extract, Glycerin, Sodium Hyaluronate, Hydrolyzed Hyaluronic Acid, Madecassic Acid, Asiaticoside, Asiatic Acid, Caprylyl Glycol, Hyaluronic Acid, Ascorbyl Glucoside, Sodium Ascorbyl Phosphate, Magnesium Ascorbyl Phosphate, Tetrahexyldecyl Ascorbate, Sodium Riboflavin Phosphate, Fragrance, Citral, Benzyl Salicylate, Linalool, Limonene

  • OTHER SAFETY INFORMATION

    Protect the product in the container from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL

    image description
  • INGREDIENTS AND APPEARANCE
    SOLFUL FACE SUNLOTION 
    homosalate, avobenzone, otisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83918-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)  
    ETHYLENE GLYCOL MONOBENZYL ETHER (UNII: 06S8147L47)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
    ARGININE (UNII: 94ZLA3W45F)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BAMBUSA VULGARIS LEAF (UNII: EMY54R518C)  
    SCLEROMITRION DIFFUSUM WHOLE (UNII: 291PPU5K9I)  
    PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    LIMONIA ACIDISSIMA WHOLE (UNII: MU5C4X2819)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    MADECASSIC ACID (UNII: M7O1N24J82)  
    ASIATICOSIDE (UNII: PKO39VY215)  
    ASIATIC ACID (UNII: 9PA5A687X5)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    RIBOFLAVIN 5'-PHOSPHATE SODIUM ANHYDROUS (UNII: 957E53WV42)  
    CITRAL (UNII: T7EU0O9VPP)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83918-001-021 in 1 CARTON12/27/2023
    1NDC:83918-001-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/27/2023
    Labeler - KARA BEAUTY INC (056308932)
    Registrant - KARA BEAUTY INC (056308932)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebom Co., Ltd.695951708manufacture(83918-001)