Label: DR.JART CICAPAIR TIGER GRASS COLOR CORRECTING TREATMENT- zinc oxide, titanium dioxide cream
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NDC Code(s):
49404-147-01,
49404-147-02,
49404-147-03,
49404-147-04, view more49404-147-05, 49404-147-06, 49404-147-07
- Packager: Have & Be Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 21, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
- For Sunscreen use: 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
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INACTIVE INGREDIENT
WATER/AQUA/EAU, ISONONYL ISONONANOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, ISOTRIDECYL ISONONANOATE, TITANIUM DIOXIDE(CI 77891), METHYLPROPANEDIOL, BIS-HYDROXYETHOXYPROPYL DIMETHICONE, METHYL METHACRYLATE CROSSPOLYMER, BUTYLOCTYL SALICYLATE, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, BEESWAX/CERA ALBA/CIRE D'ABEILLE, LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, GLYCERIN, NIACINAMIDE, DISTEARDIMONIUM HECTORITE, POLYMETHYLSILSESQUIOXANE, MAGNESIUM SULFATE, IRON OXIDES(CI 77492), TRIETHOXYCAPRYLYLSILANE, CAPRYLYL GLYCOL, CHROMIUM OXIDE GREENS, SYNTHETIC FLUORPHLOGOPITE, IRON OXIDES(CI 77491), GLYCERYL CAPRYLATE, ZEIN, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ETHYLHEXYLGLYCERIN, CENTELLA ASIATICA LEAF EXTRACT, CITRUS PARADISI (GRAPEFRUIT) PEEL OIL, SILICA DIMETHYL SILYLATE, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, ALUMINUM HYDROXIDE, ADENOSINE, ZEA MAYS (CORN) STARCH, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HYDROGENATED LECITHIN, CAPRYLHYDROXAMIC ACID, ANTHEMIS NOBILIS FLOWER OIL, TOCOPHEROL, CALCIUM STEARATE, DIPOTASSIUM PHOSPHATE, MADECASSOSIDE, SODIUM CHLORIDE, PANTHENOL, BUTYLENE GLYCOL, ANIBA ROSODORA (ROSEWOOD) WOOD OIL, GOSSYPIUM HERBACEUM (COTTON) EXTRACT, ALCOHOL, ANASTATICA HIEROCHUNTICA EXTRACT, CENTELLA ASIATICA MERISTEM CELL CULTURE, HOUTTUYNIA CORDATA EXTRACT, 1,2-HEXANEDIOL, PENTYLENE GLYCOL, MAGNESIUM ASPARTATE, ZINC GLUCONATE, ARNICA MONTANA FLOWER EXTRACT, LECITHIN, BRASSICA CAMPESTRIS (RAPESEED) STEROLS, ACHILLEA MILLEFOLIUM EXTRACT, GENTIANA LUTEA ROOT EXTRACT, ARTEMISIA ABSINTHIUM EXTRACT, LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE, POLYGLYCERYL-2 CAPRATE, SUCROSE LAURATE, CENTELLA ASIATICA EXTRACT, FRAGARIA VESCA (STRAWBERRY) FRUIT EXTRACT, PHENOXYETHANOL, PROPYLENE GLYCOL, GLUCONOLACTONE, COPPER GLUCONATE, CERAMIDE NP, LYSOLECITHIN, CITRIC ACID, XANTHAN GUM, SODIUM ASCORBYL PHOSPHATE, SODIUM BENZOATE, POTASSIUM SORBATE, LIMONENE, LINALOOL
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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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:49404-147 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.8 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 5.8 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 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) CENTELLA ASIATICA LEAF (UNII: 6810070TYD) 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) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839) TOCOPHEROL (UNII: R0ZB2556P8) CALCIUM STEARATE (UNII: 776XM7047L) MADECASSOSIDE (UNII: CQ2F5O6YIY) SODIUM CHLORIDE (UNII: 451W47IQ8X) PANTHENOL (UNII: WV9CM0O67Z) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ROSEWOOD OIL (UNII: F2522O5L7B) LEVANT COTTON SEED (UNII: 550E4N439V) ALCOHOL (UNII: 3K9958V90M) ANASTATICA HIEROCHUNTICA WHOLE (UNII: SU125S6473) HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) PENTYLENE GLYCOL (UNII: 50C1307PZG) MAGNESIUM ASPARTATE (UNII: R17X820ROL) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) RAPESEED STEROL (UNII: B46B6DD20U) ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK) GENTIANA LUTEA ROOT (UNII: S72O3284MS) WORMWOOD (UNII: F84709P2XV) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) POLYGLYCERYL-2 CAPRATE (UNII: JX7WXJ41DH) SUCROSE LAURATE (UNII: 05Q7CD0E49) CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U) FRAGARIA VESCA FRUIT (UNII: CG6IX3GCMU) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLUCONOLACTONE (UNII: WQ29KQ9POT) COPPER GLUCONATE (UNII: RV823G6G67) CERAMIDE NP (UNII: 4370DF050B) LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49404-147-01 5 mL in 1 JAR; Type 0: Not a Combination Product 10/28/2021 2 NDC:49404-147-02 10 mL in 1 JAR; Type 0: Not a Combination Product 10/28/2021 3 NDC:49404-147-03 1 mL in 1 POUCH; Type 0: Not a Combination Product 12/21/2021 4 NDC:49404-147-05 1 in 1 CARTON 12/21/2021 4 NDC:49404-147-04 15 mL in 1 JAR; Type 0: Not a Combination Product 5 NDC:49404-147-07 1 in 1 CARTON 12/21/2021 5 NDC:49404-147-06 50 mL in 1 JAR; 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 10/28/2021 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(49404-147)
