DR. ESLEE PHYSICAL SUNSCREEN- zinc oxide cream

Dr. Eslee Physical Sunscreen by

Drug Labeling and Warnings

Dr. Eslee Physical Sunscreen by is a Otc medication manufactured, distributed, or labeled by dr.eslee Lab Co., Ltd., Kolmar Korea Co.,LTD. Gwanjeong Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

zinc oxide

INACTIVE INGREDIENT

Water, Cyclopentasiloxane, Dicaprylyl Carbonate, Dipropylene Glycol, PEG-10 Dimethicone, Disteardimonium Hectorite, Portulaca Oleracea Extract, Tocopheryl Acetate, Lavendula Angustifolia (Lavender) Extract, Ocimum Basilicum (Basil) Flower/Leaf Extract, Cellulose Gum, Rosmarinus Officinalis (Rosmary) Leaf Extract, Althea Officinalis Leaf/Root Extract, Pyrus Malus (Apple) Fruit Water, Sodium Hyaluronate, Houttuynia Cordata Extract, Chamomilla Recutita (Matricaria) Flower Extract, Foeniculum Vulgare (Fennel) Fruit Extract, Magnesium Sulfate, Methicone, Methyl Methacrylate Crosspolymer, Aluminum Hydroxide, Caprylyl Glycol, Stearic Acid, Dimethicone, Glyceryl Caprylate, Polyglyceryl-6 Polycinoleate, Microcrystalline Cellulose, Phenoxy Ethanol

PURPOSE

helps to protect from UV-Rays

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

■ Apply Proper Amount of the cream on skin before sun exposure.
■ Reapply Frequently, every 2 hours for best result.

WARNINGS

■ For external use only.
■ Avoid contact with eyes.
■ Do not swallow. If swallowed, get medical help.
■ Keep out of reach of children.
■ Stop use and ask doctor if rash and irritation develops.

DOSAGE & ADMINISTRATION

for topical use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR. ESLEE PHYSICAL SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82700-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.01248 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ROSEMARY (UNII: IJ67X351P9)
ALTHAEA OFFICINALIS WHOLE (UNII: 8SG7244265)
APPLE (UNII: B423VGH5S9)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82700-0002-1	60 g in 1 TUBE; Type 0: Not a Combination Product	05/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/15/2022

Labeler - dr.eslee Lab Co., Ltd. (557804925)

Registrant - dr.eslee Lab Co., Ltd. (557804925)

Establishment
Name	Address	ID/FEI	Business Operations
dr.eslee Lab Co., Ltd.		557804925	label(82700-0002)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(82700-0002)