DR.CEURACLE HYDRA BARRIER SUNSCREEN- zinc oxide lotion

Dr.Ceuracle HYDRA BARRIER SUNSCREEN by

Drug Labeling and Warnings

Dr.Ceuracle HYDRA BARRIER SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Leegeehaam Cosmetics, KOLMAR KOREA Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient...Purpose

Zinc Oxide 17% ....... Sunscreen

Uses

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

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• 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.

Inactive ingredients

Water, Propylheptyl Caprylate, Butyloctyl Salicylate, Propanediol, Caprylyl Methicone, Isododecane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Disteardimonium Hectorite, Polyglyceryl-2 Dipolyhydroxystearate, Polymethylsilsesquioxane, Magnesium Sulfate, Triethoxycaprylylsilane, Methyl Methacrylate Crosspolymer, 1,2-Hexanediol, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Glyceryl Caprylate, Caprylyl Glycol, Octyldodecanol, Ethylhexylglycerin, Echium Plantagineum Seed Oil, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Sodium Hyaluronate, Panthenol, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Citric Acid

Other information

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

Dosage and Administration

Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours.

Keep out of reach of children

Keep out of reach of children

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 product is swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.CEURACLE HYDRA BARRIER SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84773-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	170 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: H49Q67JS3B)
ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)
CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
OCTYLDODECANOL (UNII: 461N1O614Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TOCOPHEROL (UNII: R0ZB2556P8)
SUNFLOWER OIL UNSAPONIFIABLES (UNII: T7ZE2WA4MB)
PANTHENOL (UNII: WV9CM0O67Z)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
PROPANEDIOL (UNII: 5965N8W85T)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ISODODECANE (UNII: A8289P68Y2)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84773-001-03	10 in 1 BOX	02/01/2025
1	NDC: 84773-001-02	1 in 1 PACKAGE
1	NDC: 84773-001-01	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	02/01/2025

Labeler - Leegeehaam Cosmetics (689716868)

Registrant - KOLMAR KOREA Co., Ltd. (557822156)

Establishment
Name	Address	ID/FEI	Business Operations
KOLMAR KOREA Co., Ltd.		963271745	manufacture(84773-001)