SOLFUL SPRITZ FACE SUN MIST- homosalate, avobenzone, otisalate, octocrylene spray

solful spritz face sun mist by

Drug Labeling and Warnings

solful spritz face sun mist 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

Octocrylene 9.5%, Homosalate 7.3%, Octisalate 4.8%, Avobenzone 2.8%

INDICATIONS & USAGE

Helps prevent sunburn

DOSAGE & ADMINISTRATION

 Shake well before use  Hold container 4 to 6 inches from the skin to apply  Spray liberally and spread evenly by hand 15 minutes before sun exposure  Do not spray directly into face  Spray on hands then apply to face  Do not apply in windy conditions  Use in well-ventilated area  reapply after 40 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours  Ask a doctor to use for children under 6 months
 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

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

Alcohol, Butyloctyl Salicylate, Water, Benzyl Glycol, Ethylhexylglycerin, Butylene Glycol, 1,2-Hexanediol, Glycerin, Ethyl Hexanediol, Melaleuca Alternifolia (Tea Tree) Leaf Water, Centella Asiatica Extract, Madecassic Acid, Asiaticoside, Asiatic Acid, Aloe Barbadensis Leaf Juice, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citral, Linalool, Limonene

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOLFUL SPRITZ FACE SUN MIST 
homosalate, avobenzone, otisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83918-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	73 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	95 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	48 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	28 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
WATER (UNII: 059QF0KO0R)
ETHYLENE GLYCOL MONOBENZYL ETHER (UNII: 06S8147L47)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GLYCERIN (UNII: PDC6A3C0OX)
ETHOHEXADIOL (UNII: M9JGK7U88V)
TEA TREE OIL (UNII: VIF565UC2G)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
MADECASSIC ACID (UNII: M7O1N24J82)
ASIATICOSIDE (UNII: PKO39VY215)
ASIATIC ACID (UNII: 9PA5A687X5)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BERGAMOT OIL (UNII: 39W1PKE3JI)
CITRAL (UNII: T7EU0O9VPP)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83918-002-02	1 in 1 CARTON	06/02/2024
1	NDC: 83918-002-01	100 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	06/02/2024

Labeler - KARA BEAUTY INC (056308932)

Registrant - KARA BEAUTY INC (056308932)

Establishment
Name	Address	ID/FEI	Business Operations
Rebom Co., Ltd.		695951708	manufacture(83918-002)