NDC | 49404-140-01, 49404-140-02, 49404-140-03, 49404-140-04 |
Set ID | e9a38ac6-147e-4a63-9061-a8b445a0503f |
Category | HUMAN OTC DRUG LABEL |
Packager | Have & Be Co., Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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
- KEEP OUT OF REACH OF CHILDREN
-
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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DR.JART CICAPAIR TIGER GRASS COLOR CORRECTING TREATMENT
zinc oxide, titanium dioxide creamProduct 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)