GOODAL HEARTLEAF SOOTHING ZINC 100 MINERAL SUNSCREEN- zinc oxide cream

GOODAL HEARTLEAF SOOTHING ZINC 100 MINERAL SUNSCREEN by

Drug Labeling and Warnings

GOODAL HEARTLEAF SOOTHING ZINC 100 MINERAL SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by CLIO COSMETICS Co., Ltd., Kolmar Korea Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 21.96%

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, DIMETHICONE, PROPYLHEPTYL CAPRYLATE, METHYL TRIMETHICONE, BUTYLOCTYL SALICYLATE, PROPANEDIOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, ALCOHOL, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, DICAPRYLYL CARBONATE, C9-12 ALKANE, DISTEARDIMONIUM HECTORITE, METHYL METHACRYLATE CROSSPOLYMER, BENZOTRIAZOLYL DODECYL P-CRESOL, LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, MAGNESIUM SULFATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, 1,2-HEXANEDIOL, SILICA, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, CAPRYLYL GLYCOL, DIMETHICONOL, TRISILOXANE, OLEA EUROPAEA (OLIVE) FRUIT OIL, ETHYLHEXYLGLYCERIN, DIPROPYLENE GLYCOL, SODIUM CITRATE, ABIES SIBIRICA OIL, TOCOPHEROL, BUTYLENE GLYCOL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, SALVIA SCLAREA (CLARY) OIL, PELARGONIUM GRAVEOLENS FLOWER OIL, EUGENIA CARYOPHYLLUS (CLOVE) LEAF OIL, ANTHEMIS NOBILIS FLOWER OIL, POGOSTEMON CABLIN OIL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER OIL, JUNIPERUS MEXICANA OIL, NIACINAMIDE, CERAMIDE NP, LACTOBACILLUS FERMENT, PENTYLENE GLYCOL, GLYCERYL GLUCOSIDE, HOUTTUYNIA CORDATA EXTRACT, GANODERMA LUCIDUM (MUSHROOM) STEM EXTRACT, GLYCERIN, DIMETHYLSILANOL HYALURONATE, HYDROLYZED HYALURONIC ACID, HYDROLYZED SODIUM HYALURONATE, SODIUM HYALURONATE, HYALURONIC ACID, POTASSIUM HYALURONATE, SODIUM HYALURONATE CROSSPOLYMER, HYDROXYPROPYLTRIMONIUM HYALURONATE, ACETYL HEXAPEPTIDE-8, SODIUM HYALURONATE DIMETHYLSILANOL, SODIUM ACETYLATED HYALURONATE

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GOODAL HEARTLEAF SOOTHING ZINC 100 MINERAL SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84532-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	219.606 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PROPANEDIOL (UNII: 5965N8W85T)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
ALCOHOL (UNII: 3K9958V90M)
LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE (UNII: 35J49U6PZS)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
C9-12 ALKANE (UNII: 7J5R5W72QM)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRISILOXANE (UNII: 9G1ZW13R0G)
OLIVE OIL (UNII: 6UYK2W1W1E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ABIES SIBIRICA LEAF OIL (UNII: XRY0V4VZKZ)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ROSEMARY OIL (UNII: 8LGU7VM393)
CLARY SAGE OIL (UNII: 87L0D4U3M0)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
CLOVE LEAF OIL (UNII: VCA5491KVF)
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686)
NIACINAMIDE (UNII: 25X51I8RD4)
CERAMIDE NP (UNII: 4370DF050B)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
GLYCERYL GLUCOSIDE (UNII: 3297VXM8Z6)
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
GANODERMA LUCIDUM STEM (UNII: U8PA41532G)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHYLSILANOL HYALURONATE (UNII: Z853O1D4TE)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HYALURONIC ACID (UNII: S270N0TRQY)
ACETYL HEXAPEPTIDE-8 AMIDE (UNII: L4EL31FWIL)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84532-003-02	1 in 1 CARTON	03/15/2026
1	NDC: 84532-003-01	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	03/15/2026

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd		963271745	manufacture(84532-003)