SOLFUL FACE SUNLOTION- homosalate, avobenzone, otisalate, octocrylene lotion 
KARA BEAUTY INC

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83918-001_solful face sun lotion

Sunscreen

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

Helps prevent sunburn

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

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

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

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

image description
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)

Revised: 12/2023
Document Id: 0d9b03a5-1bcc-f586-e063-6394a90a1bab
Set id: 1946b94b-43ae-4183-9eae-1112f0a2c951
Version: 1
Effective Time: 20231228
 
KARA BEAUTY INC