Label: DR.JART PREMIUM BEAUTY BALM MEDIUM-TAN- zinc oxide, titanium dioxide, octinoxate, octisalate cream
- NDC Code(s): 49404-150-02
- Packager: Have & Be Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 20, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
For sunscreen use:
■ apply liberally 15 minutes before sun exposure
■ reapply at least every two hours
■ use a water resistant sunscreen if swimming or sweating
■ 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 a.m. – 2 p.m.
– wear long-sleeved shirts, pants, hats and sunglasses
■ children under 6 months of age: ask a doctor - WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
WATER, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, GLYCERIN, TALC, PEG-10 DIMETHICONE, IRON OXIDES(CI 77492), C12-15 ALKYL BENZOATE, HEXYL LAURATE, DIPHENYLSILOXY PHENYL TRIMETHICONE, NIACINAMIDE, DIPROPYLENE GLYCOL, DISTEARDIMONIUM HECTORITE, TITANIUM DIOXIDE(CI 77891), MAGNESIUM SULFATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DIMETHICONE, IRON OXIDES(CI 77491), TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, IRON OXIDES(CI 77499), METHICONE, POLYGLYCERYL-6 POLYRICINOLEATE, TRIHYDROXYSTEARIN, ETHYLHEXYLGLYCERIN, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, ADENOSINE, CITRUS AURANTIFOLIA (LIME) OIL, PINUS SYLVESTRIS LEAF OIL, BHT, EUCALYPTUS GLOBULUS LEAF OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, CITRUS LIMON (LEMON) PEEL OIL, TOCOPHEROL, ALLANTOIN, GLYCERYL POLYMETHACRYLATE, PROPYLENE GLYCOL, 1,2-HEXANEDIOL, POLYSORBATE 80, PLATINUM POWDER, PALMITOYL TRIPEPTIDE-1
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR.JART PREMIUM BEAUTY BALM MEDIUM-TAN
zinc oxide, titanium dioxide, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49404-150 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.8 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 5 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.8 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) TALC (UNII: 7SEV7J4R1U) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) NIACINAMIDE (UNII: 25X51I8RD4) DIPROPYLENE GLYCOL (UNII: E107L85C40) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) DIMETHICONE (UNII: 92RU3N3Y1O) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) METHICONE (20 CST) (UNII: 6777U11MKT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ADENOSINE (UNII: K72T3FS567) ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B) LIME OIL, COLD PRESSED (UNII: UZH29XGA8G) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) EUCALYPTUS OIL (UNII: 2R04ONI662) BERGAMOT OIL (UNII: 39W1PKE3JI) LEMON OIL, COLD PRESSED (UNII: I9GRO824LL) TOCOPHEROL (UNII: R0ZB2556P8) ALLANTOIN (UNII: 344S277G0Z) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PLATINUM (UNII: 49DFR088MY) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49404-150-02 1 in 1 CARTON 04/25/2022 1 40 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 04/25/2022 Labeler - Have & Be Co., Ltd. (690400408) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co., Ltd. 963271750 manufacture(49404-150)