DR.JART CICAPAIR TIGER GRASS COLOR CORRECTING TREATMENT- zinc oxide, titanium dioxide cream

Dr.Jart Cicapair Tiger Grass Color Correcting Treatment by

Drug Labeling and Warnings

Dr.Jart Cicapair Tiger Grass Color Correcting Treatment 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 5.76%

Titanium Dioxide 4.72%

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, CENTELLA ASIATICA LEAF WATER, ISONONYL ISONONANOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, ISOTRIDECYL ISONONANOATE, METHYLPROPANEDIOL, BIS-HYDROXYETHOXYPROPYL DIMETHICONE, METHYL METHACRYLATE CROSSPOLYMER, BUTYLOCTYL SALICYLATE, POLYGLYCERYL-4DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, BEESWAX, LAURYL POLYGLYCERYL-3POLYDIMETHYLSILOXYETHYL DIMETHICONE, GLYCERIN, NIACINAMIDE, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, POLYMETHYLSILSESQUIOXANE, IRON OXIDES(CI 77492), TRIETHOXYCAPRYLYLSILANE, CAPRYLYL GLYCOL, CHROMIUM OXIDE GREENS, SYNTHETIC FLUORPHLOGOPITE, IRON OXIDES(CI 77491), GLYCERYL CAPRYLATE, ZEIN, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ETHYLHEXYLGLYCERIN, CITRUS PARADISI (GRAPEFRUIT) PEEL OIL, SILICA DIMETHYL SILYLATE, ROSMARINUS OFFICINALIS (ROSEMARY) LEAFOIL, ALUMINUM HYDROXIDE, ADENOSINE, ZEA MAYS (CORN) STARCH, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HYDROGENATED LECITHIN, ANTHEMIS NOBILIS FLOWER OIL, TOCOPHEROL, DIPOTASSIUM PHOSPHATE, MADECASSOSIDE, SODIUM CHLORIDE, CALCIUM STEARATE, BUTYLENE GLYCOL, PANTHENOL , HOUTTUYNIA CORDATA EXTRACT , ANIBA ROSODORA (ROSEWOOD) WOOD OIL, GOSSYPIUM HERBACEUM (COTTON) EXTRACT, ALCOHOL , CENTELLA ASIATICA MERISTEM CELL CULTURE, ANASTATICA HIEROCHUNTICA EXTRACT, 1,2-HEXANEDIOL, PENTYLENE GLYCOL, MAGNESIUM ASPARTATE, ZINC GLUCONATE, ARNICA MONTANA FLOWER EXTRACT, LECITHIN, BRASSICA CAMPESTRIS (RAPESEED) STEROLS, GENTIANA LUTEA ROOT EXTRACT, ACHILLEA MILLEFOLIUM EXTRACT, ARTEMISIA ABSINTHIUM EXTRACT, LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE, SUCROSE LAURATE, POLYGLYCERYL-2 CAPRATE, CENTELLA ASIATICA EXTRACT, FRAGARIA VESCA (STRAWBERRY) FRUIT EXTRACT, PHENOXYETHANOL, GLUCONOLACTONE, LYSOLECITHIN, CERAMIDE NP, COPPER GLUCONATE, SODIUM BENZOATE, SODIUM ASCORBYL PHOSPHATE, XANTHAN GUM, POTASSIUM SORBATE, DISODIUM EDTA, MADECASSIC ACID, ASIATICOSIDE, ASIATIC ACID

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 CICAPAIR TIGER GRASS COLOR CORRECTING TREATMENT 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49404-140
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.36 mg  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.88 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
YELLOW WAX (UNII: 2ZA36H0S2V)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHROMIC OXIDE (UNII: X5Z09SU859)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
ZEIN (UNII: 80N308T1NN)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GRAPEFRUIT OIL (UNII: YR377U58W9)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ROSEMARY OIL (UNII: 8LGU7VM393)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ADENOSINE (UNII: K72T3FS567)
STARCH, CORN (UNII: O8232NY3SJ)
SUNFLOWER OIL (UNII: 3W1JG795YI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49404-140-02	1 in 1 CARTON	05/02/2018
1	NDC: 49404-140-01	50 mL in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 49404-140-04	1 in 1 PACKAGE	05/02/2018
2	NDC: 49404-140-03	15 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	05/02/2018

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(49404-140)