ABIB HEARTLEAF MILD SUNSCREEN RELIEF TUBE- zinc oxide cream

Abib Heartleaf mild sunscreen Relief tube by

Drug Labeling and Warnings

Abib Heartleaf mild sunscreen Relief tube by is a Otc medication manufactured, distributed, or labeled by FOURCOMPANY CO., LTD., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient(s)

Zinc Oxide 19.32%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Use(s)

■ Helps prevent sunburn

■ If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS

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 use and ask a doctor if rash occurs

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

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.

DOSAGE & ADMINISTRATION

Directions

■ Apply liberally and evenly 15 minutes before sun exposure

■ Reapply at least every 2 hours

■ Use a water-resistant sunscreen if swimming or sweating

■ Children under 6 months of age: Ask a doctor

■ 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:

■ Limit time in the sun, especially from 10 a.m. ‒ 2 p.m.

■ Wear long-sleeved shirts, pants, hats, and sunglasses

OTHER SAFETY INFORMATION

Other Information

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

QUESTIONS

Questions

■ contact@fourco.co.kr

INACTIVE INGREDIENT

Inactive ingredients

Water, Butyloctyl Salicylate, Propylheptyl Caprylate, Propanediol, C15-19 Alkane, Disiloxane, Isododecane, Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone, Caprylyl Methicone, Isopropyl Myristate, Sodium Chloride, Triethylhexanoin, Glycerin, Disteardimonium Hectorite, Methyl Methacrylate Crosspolymer, Polymethylsilsesquioxane, Triethoxycaprylylsilane, 1,2-Hexanediol, Dipentaerythrityl Tri-Polyhydroxystearate, Houttuynia Cordata Extract, Lauryl Dimethicone/Polyglycerin-3 Crosspolymer, Polyglyceryl-2 Dipolyhydroxystearate, Panthenol, Caprylyl Glycol, Glyceryl Caprylate, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Coccinia Indica Fruit Extract, Butylene Glycol, Amber Powder, Solanum Melongena (Eggplant) Fruit Extract, Curcuma Longa (Turmeric) Root Extract, Dipropylene Glycol, Ocimum Sanctum Leaf Extract, Corallina Officinalis Extract, Moringa Oleifera Seed Oil, Tocopherol, Sodium Citrate, Lecithin, Sodium Hyaluronate, Allantoin, Dipotassium Glycyrrhizate, Sodium PCA, Arginine, Ceramide NP, Erythritol, Asiaticoside, Madecassic Acid, Asiatic Acid, Centella Asiatica Extract, Pentylene Glycol, Octanediol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ABIB HEARTLEAF MILD SUNSCREEN RELIEF TUBE 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73676-217
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	19.32 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CETYL DIGLYCERYL TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE (950 MM2/S) (UNII: C982F2EKT3)
DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52)
C15-19 ALKANE (UNII: CI87N1IM01)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPANEDIOL (UNII: 5965N8W85T)
DISILOXANE (UNII: D7M4659BPU)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73676-217-02	1 in 1 CARTON	05/01/2025
1	NDC: 73676-217-01	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	05/01/2025

Labeler - FOURCOMPANY CO., LTD. (694864584)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(73676-217)