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

solful face sunlotion by

Drug Labeling and Warnings

solful face sunlotion by is a Otc medication manufactured, distributed, or labeled by KARA BEAUTY INC, Rebom Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SOLFUL FACE SUNLOTION 
homosalate, avobenzone, otisalate, octocrylene lotion

Product 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)