UV DEFENSE ME. NO SEBUM SUNSCREEN- zinc oxide cream

UV defense me. No sebum sunscreen by

Drug Labeling and Warnings

UV defense me. No sebum sunscreen by is a Otc medication manufactured, distributed, or labeled by Magnif Co., Ltd, Korea Kolmar Co. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

ZINC OXIDE (22.24%)

Purpose

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

Keep out of reach of children

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

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.

Inactive Ingredients

WATER, CYCLOHEXASILOXANE, CAPRYLYL METHICONE, BUTYLENE GLYCOL, DICAPRYLATE/DICAPRATE, BUTYLOCTYL SALICYLATE, DIPROPYLENE GLYCOL, PROPYLHEPTYL CAPRYLATE, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, METHYL METHACRYLATE CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, TRIETHOXYCAPRYLYLSILANE, 1,2-HEXANEDIOL, POLYGLYCERYL-2 TRIISOSTEARATE, LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, FRAGRANCE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, SODIUM HYALURONATE, TOCOPHEROL, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYGLYCERYL-10 DIISOSTEARATE, HYDROGENATED LECITHIN, MENADIONE, CENTELLA ASIATICA EXTRACT, BETA-GLUCAN

Directions

For sunscreen use:

apply liberally 15 minutes before sun exposure
reapply at least every 2 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:

limit time in the sun, especially from 10 a.m. – 2 p.m.
wear long-resistant shirts, pants, hats, and sunglasses

children under 6 months of age: Ask a doctor

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UV DEFENSE ME. NO SEBUM SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84523-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	11.12 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MENADIONE (UNII: 723JX6CXY5)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84523-101-02	1 in 1 BOX	07/09/2024
1	NDC: 84523-101-01	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	07/09/2024

Labeler - Magnif Co., Ltd (694496350)

Establishment
Name	Address	ID/FEI	Business Operations
Korea Kolmar Co. Ltd		963271745	manufacture(84523-101)