GOODAL HEARTLEAF SOOTHING MOISTURE SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene cream

GOODAL HEARTLEAF SOOTHING MOISTURE SUNSCREEN by

Drug Labeling and Warnings

GOODAL HEARTLEAF SOOTHING MOISTURE SUNSCREEN 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 2.85%

Homosalate 7.00%

Octisalate 4.50%

Octocrylene 9.00%

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

Water, Butylene Glycol, Tripropylene Glycol, Silica, Ethylhexyl Methoxycrylene, Diethylhexyl 2,6-Naphthalate, 1,2-Hexanediol, Dimethicone, Methyl Trimethicone, Pentylene Glycol, Polymethylsilsesquioxane, Hydroxyethyl Urea, Poly C10-30 Alkyl Acrylate, Cetearyl Olivate, Sorbitan Olivate, Cetyl Alcohol, Tromethamine, Polyacrylic Acid, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Carbomer, Sodium Stearoyl Glutamate, Xanthan Gum, Ethylhexylglycerin, Houttuynia Cordata Extract, Glycerin, Tocopherol, Ceramide NP, Pyrus Malus (Apple) Fruit Extract, Propanediol, Dipotassium Phosphate, Acetyl Glutamine, Soluble Collagen, Sodium Chloride, Camellia Sinensis Leaf Extract, Mentha Rotundifolia Leaf Extract, Thymus Vulgaris (Thyme) Leaf Extract, Dimethylsilanol Hyaluronate, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Bacillus Ferment, Hyaluronic Acid, Magnesium Chloride, Potassium Hyaluronate, Sodium Hyaluronate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Trifluoroacetate, Hydroxypropyltrimonium Hyaluronate, Sodium Hyaluronate Crosspolymer, Cellulose Gum, Hydrolyzed Collagen, Sodium Hyaluronate Dimethylsilanol, Sodium Acetylated Hyaluronate, Sodium Bicarbonate, Calcium Chloride, Potassium Chloride, Collagen Extract

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GOODAL HEARTLEAF SOOTHING MOISTURE SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84532-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	90 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	28.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIPROPYLENE GLYCOL (UNII: 3C8845E7C1)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CETYL ALCOHOL (UNII: 936JST6JCN)
TROMETHAMINE (UNII: 023C2WHX2V)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
GLYCERIN (UNII: PDC6A3C0OX)
TOCOPHEROL (UNII: R0ZB2556P8)
CERAMIDE NP (UNII: 4370DF050B)
APPLE (UNII: B423VGH5S9)
PROPANEDIOL (UNII: 5965N8W85T)
POTASSIUM PHOSPHATE, DIBASIC, TRIHYDRATE (UNII: RJK174X3TZ)
ACEGLUTAMIDE (UNII: 01J18G9G97)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MENTHA X ROTUNDIFOLIA LEAF (UNII: K59TXG2L3U)
THYMUS VULGARIS LEAF (UNII: GRX3499643)
DIMETHYLSILANOL HYALURONATE (UNII: Z853O1D4TE)
HYALURONIC ACID (UNII: S270N0TRQY)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE (UNII: 0UBP26S1LG)
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: 84532-002-02	1 in 1 CARTON	03/09/2026
1	NDC: 84532-002-01	50 mL in 1 TUBE; 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	03/09/2026

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(84532-002)