GOODAL HEARTLEAF SOOTHING QUICK SLIDING SUNSCREEN STICK- avobenzone, homosalate, octisalate, octocrylene stick

GOODAL HEARTLEAF SOOTHING QUICK SLIDING SUNSCREEN Stick by

Drug Labeling and Warnings

GOODAL HEARTLEAF SOOTHING QUICK SLIDING SUNSCREEN Stick by is a Otc medication manufactured, distributed, or labeled by CLIO COSMETICS Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 2.8%

Homosalate 6.5%

Octisalate 4.5%

Octocrylene 6.5%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn
If used as directed with other sun protection measures (see Directions) decrease the risk of skin cancer and early skin aging caused by the sun

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure
Reapply at least every two hours
Use a water-resistant sunscreen if swimming or sweating

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 value of 15 or higher and other sun protection measures including: 1) Limit time in the sun, especially from 10 a.m. to 2 p.m. 2) Wear long-sleeved shirts, pants, hats, and sunglasses

WARNINGS

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

INACTIVE INGREDIENT

Octyldodecanol, Butylene Glycol Dicaprylate/Dicaprate, Diethylhexyl Carbonate, Dibutyl Lauroyl Glutamide, Isopropyl Palmitate, Dibutyl Ethylhexanoyl Glutamide, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Diisostearyl Malate, Dextrin Palmitate, Polyamide-8, Water, Houttuynia Cordata Extract, Glycerin, Butylene Glycol, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, 1,2-Hexanediol, Ethylhexylglycerin, Adenosine, Ectoin, Niacinamide, Dipotassium Phosphate, Acetyl Glutamine, Propanediol, Sucrose Palmitate, Hydrogenated Lecithin, Macadamia Integrifolia Seed Oil, Olea Europaea (Olive) Fruit Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Sodium Chloride, Dimethylsilanol Hyaluronate, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Hyaluronic Acid, Potassium Hyaluronate, Sodium Hyaluronate, Hydroxypropyltrimonium Hyaluronate, Sodium Hyaluronate Crosspolymer, Cellulose Gum, Sodium Hyaluronate Dimethylsilanol, Sodium Acetylated Hyaluronate, Sodium Bicarbonate, Calcium Chloride, Potassium Chloride

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GOODAL HEARTLEAF SOOTHING QUICK SLIDING SUNSCREEN STICK 
avobenzone, homosalate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84532-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)
WATER (UNII: 059QF0KO0R)
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TROMETHAMINE (UNII: 023C2WHX2V)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
ECTOINE (UNII: 7GXZ3858RY)
NIACINAMIDE (UNII: 25X51I8RD4)
ACEGLUTAMIDE (UNII: 01J18G9G97)
PROPANEDIOL (UNII: 5965N8W85T)
SUCROSE PALMITATE (UNII: 3OSQ643ZK5)
MACADAMIA INTEGRIFOLIA SEED OIL (UNII: 7VK9GL8RUP)
OLIVE OIL (UNII: 6UYK2W1W1E)
JOJOBA OIL (UNII: 724GKU717M)
GRAPE SEED OIL (UNII: 930MLC8XGG)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHYLSILANOL HYALURONATE (UNII: Z853O1D4TE)
HYALURONIC ACID (UNII: S270N0TRQY)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM HYALURONATE CROSSPOLYMER-1 (UNII: 4D4QKG9VN2)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84532-004-02	1 in 1 CARTON	03/15/2026
1	NDC: 84532-004-01	22 g 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	03/15/2026

Labeler - CLIO COSMETICS Co., Ltd. (689115249)

Registrant - CLIO COSMETICS Co., Ltd. (689115249)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(84532-004)