Label: JUNGSAEMMOOL SKIN SETTING TONE BALANCING BASE- titanium dioxide, octinoxate, zinc oxide, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71261-010-01, 71261-010-02 - Packager: Jungsaemmool Beauty 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 July 14, 2020
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
Apply liberally 15 minutes before sun exposure. Reapply at least every two 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
Ask a doctor to use for children under 6 months
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Water, Cyclopentasiloxane, Diphenylsiloxy Phenyl Trimethicone, Cyclohexasiloxane, Pentaerythrityl Tetraethylhexanoate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Mica (CI 77019), Butylene Glycol, Glycerin, Niacinamide, Pentylene Glycol, Disteardimonium Hectorite, Cetyl PEG/PPG-10/1 Dimethicone, PEG-10 Dimethicone, Tribehenin, Magnesium Sulfate, Iron Oxides (CI 77492), Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Phenoxyethanol, Diphenyl Dimethicone, Stearic Acid, Iron Oxides (CI 77491), Ceresin, Triethoxycaprylylsilane, Iron Oxides (CI 77499), Dimethicone, Fragrance(Parfum), Ethylhexylglycerin, Adenosine, Disodium EDTA, Ethylhexyl Palmitate, Tocopherol, Sodium PCA, Magnesium PCA, Zinc PCA, Silica Dimethyl Silylate, Caprylyl Glycol, Manganese PCA, Actinidia Polygama Fruit Extract, Potassium Sorbate, Sodium Hyaluronate, Hexylene Glycol
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
JUNGSAEMMOOL SKIN SETTING TONE BALANCING BASE
titanium dioxide, octinoxate, zinc oxide, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71261-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 91 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 70 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 49 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) CYCLOMETHICONE 6 (UNII: XHK3U310BA) PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) MICA (UNII: V8A1AW0880) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) NIACINAMIDE (UNII: 25X51I8RD4) PENTYLENE GLYCOL (UNII: 50C1307PZG) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) TRIBEHENIN (UNII: 8OC9U7TQZ0) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIPHENYL DIMETHICONE (100 CST) (UNII: AG1ANB6B8O) STEARIC ACID (UNII: 4ELV7Z65AP) FERRIC OXIDE RED (UNII: 1K09F3G675) CERESIN (UNII: Q1LS2UJO3A) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ADENOSINE (UNII: K72T3FS567) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ETHYLHEXYL PALMITATE (UNII: 2865993309) TOCOPHEROL (UNII: R0ZB2556P8) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) MAGNESIUM PIDOLATE (UNII: V5PC588N7G) ZINC PIDOLATE (UNII: C32PQ86DH4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MANGANESE PIDOLATE (UNII: 3S6I84YKIV) ACTINIDIA POLYGAMA FRUIT (UNII: CJA97047JF) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) HYALURONATE SODIUM (UNII: YSE9PPT4TH) HEXYLENE GLYCOL (UNII: KEH0A3F75J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71261-010-02 1 in 1 CARTON 07/14/2020 1 NDC:71261-010-01 40 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 07/14/2020 Labeler - Jungsaemmool Beauty Co., Ltd. (694214725) Registrant - Jungsaemmool Beauty Co., Ltd. (694214725) Establishment Name Address ID/FEI Business Operations Shinsegae Intercos Korea Inc. 694526100 manufacture(71261-010)
