Label: DR.JART DIS-A-PORE BEAUTY BALM 02- titanium dioxide, octinoxate, octisalate cream
- NDC Code(s): 49404-146-02
- Packager: Have & Be Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 20, 2024
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- Official Label (Printer Friendly)
- 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, CYCLOPENTASILOXANE, DIMETHICONE/VINYL DIMETHICONECROSSPOLYMER, ISODODECANE, LAURYL PEG-10TRIS(TRIMETHYLSILOXY)SILYLETHYLDIMETHICONE, DIMETHICONE, NIACINAMIDE, METHYLPROPANEDIOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, IRON OXIDES(CI 77492), DISTEARDIMONIUM HECTORITE, GLYCERIN, MAGNESIUM SULFATE, ISOPROPYL PALMITATE, HDI/TRIMETHYLOL HEXYLLACTONECROSSPOLYMER, TRIETHOXYCAPRYLYLSILANE, IRON OXIDES(CI 77491), DIPENTAERYTHRITYLHEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, POLYGLYCERYL-4 ISOSTEARATE, ALUMINUM HYDROXIDE, IRON OXIDES(CI 77499), CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, TRIHYDROXYSTEARIN, ETHYLHEXYLGLYCERIN, PINUS SYLVESTRIS LEAF OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT)FRUIT OIL, SILICA, ADENOSINE, SYNTHETIC FLUORPHLOGOPITE, BHT, TOCOPHEROL, BUTYLENE GLYCOL, ALCOHOL, 1,2-HEXANEDIOL, LECITHIN, PISTACIA LENTISCUS (MASTIC) GUM
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DR.JART DIS-A-PORE BEAUTY BALM 02
titanium dioxide, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49404-146 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6.388 mg in 40 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.996 mg in 40 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.2 mg in 40 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) ISODODECANE (UNII: A8289P68Y2) DIMETHICONE (UNII: 92RU3N3Y1O) NIACINAMIDE (UNII: 25X51I8RD4) METHYLPROPANEDIOL (UNII: N8F53B3R4R) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) GLYCERIN (UNII: PDC6A3C0OX) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49404-146-02 1 in 1 CARTON 11/07/2019 1 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 Drug M020 11/07/2019 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(49404-146)