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
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- Official Label (Printer Friendly)
- PURPOSE
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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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
- KEEP OUT OF REACH OF CHILDREN
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SOLFUL FACE SUNLOTION
homosalate, avobenzone, otisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83918-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 40 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:83918-001-02 1 in 1 CARTON 12/27/2023 1 NDC:83918-001-01 50 mL in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 12/27/2023 Labeler - KARA BEAUTY INC (056308932) Registrant - KARA BEAUTY INC (056308932) Establishment Name Address ID/FEI Business Operations Rebom Co., Ltd. 695951708 manufacture(83918-001)