DR.JART EVERY SUN DAY MINERAL SUN SCREEN- zinc oxide, titanium dioxide cream

Dr.Jart Every Sun Day Mineral Sun Screen by

Drug Labeling and Warnings

Dr.Jart Every Sun Day Mineral Sun Screen by is a Otc medication manufactured, distributed, or labeled by Have & Be Co., Ltd., Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 11.5%

Titanium Dioxide 4.1%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

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

DOSAGE & ADMINISTRATION

• Apply liberally 15 minutes before sun exposure.

• Use a water resistant sunscreen if swimming or sweating

• 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 am - 2 pm

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

• Children under 6 months: Ask a doctor

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 using and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT

Water, CYCLOPENTASILOXANE, PROPANEDIOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, LAURYL POLYGLYCERYL-3POLYDIMETHYLSILOXYETHYL DIMETHICONE, METHYL METHACRYLATE CROSSPOLYMER, BUTYLOCTYL SALICYLATE, CAPRYLYL METHICONE, 1,2-HEXANEDIOL, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, STEARIC ACID, ALUMINUM HYDROXIDE, POLYGLYCERYL-3, POLYDIMETHYLSILOXYETHYLDIMETHICONE, TRIETHOXYCAPRYLYLSILANE, SORBITAN CAPRYLATE, CITRUS AURANTIUM DULCIS (ORANGE) OIL, GLYCERYL CAPRYLATE, ETHYLHEXYLGLYCERIN, CITRUS NOBILIS (MANDARIN ORANGE) PEEL OIL, LITSEA CUBEBA FRUIT OIL, TOCOPHEROL

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sunlight

You may report a serious adverse event from use of this product to: Report Reaction, LLC PO Box 22 Plainsboro, NJ 08536-0222

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.JART EVERY SUN DAY MINERAL SUN SCREEN 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49404-143
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.05 mg  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	5.75 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPANEDIOL (UNII: 5965N8W85T)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49404-143-02	1 in 1 CARTON	10/31/2019
1	NDC: 49404-143-01	50 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/31/2019

Labeler - Have & Be Co., Ltd. (690400408)

Registrant - Have & Be Co., Ltd. (690400408)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(49404-143)