Label: DR.JART BLACK LABEL DETOX BEAUTY BALM- titanium dioxide, octinoxate, octisalate, zinc oxide cream
- NDC Code(s): 49404-139-01, 49404-139-02
- 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
-
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
PHENYL TRIMETHICONE
METHYLPROPANEDIOL
CAPRYLIC/CAPRIC TRIGLYCERIDE
CYCLOMETHICONE
GLYCERIN
LAURYL PEG-10TRIS(TRIMETHYLSILOXY)SILYLETHYLDIMETHICONE
NIACINAMIDDIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE
DIMETHICONE/VINYL DIMETHICONECROSSPOLYMER
PENTYLENE GLYCOL
DISTEARDIMONIUM HECTORITE
DIISOSTEARYL MALATE
ISOEICOSANE
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYLDIMETHICONE
SYNTHETIC FLUORPHLOGOPITE
MAGNESIUM SULFATE
IRON OXIDES(CI 77492)
SILICA DIMETHYL SILYLATE
ACRYLATES/DIMETHICONE COPOLYMER
TRIETHOXYCAPRYLYLSILANE
ORYZA SATIVA (RICE) BRAN OIL
VEGETABLE OIL
IRON OXIDES(CI 77491)
IRON OXIDES(CI 77499)
CAPRYLYL GLYCOL
GLYCERYL CAPRYLATE
AMINOPROPYL DIMETHICONE
RHUS SUCCEDANEA FRUIT WAX
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX
ORYZA SATIVA (RICE) BRAN WAX
POLYMETHYLSILSESQUIOXANE
ETHYLHEXYLGLYCERIN
TOCOPHERYL ACETATE
ALUMINA
ALUMINUM HYDROXIDE
SILICA
ADENOSINE
CITRUS AURANTIUM DULCIS (ORANGE) PEELOIL
DIMETHICONE
SODIUM HYALURONATE
PINUS SYLVESTRIS LEAF OIL
CITRUS AURANTIFOLIA (LIME) OIL
EUCALYPTUS GLOBULUS LEAF OIL
TOCOPHEROL
CITRUS LIMON (LEMON) PEEL OIL
CITRUS AURANTIUM BERGAMIA (BERGAMOT)FRUIT OIL
ASCORBYL PALMITATE
BUTYLENE GLYCOL
CAMELLIA SINENSIS LEAF EXTRACT
PORTULACA OLERACEA EXTRACT
CYNARA SCOLYMUS (ARTICHOKE) LEAFEXTRACT
ALOE BARBADENSIS LEAF EXTRACT
1,2-HEXANEDIOL - OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DR.JART BLACK LABEL DETOX BEAUTY BALM
titanium dioxide, octinoxate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49404-139 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.328 mg in 40 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.4 mg in 40 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.784 mg in 40 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.8 mg in 40 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) METHYLPROPANEDIOL (UNII: N8F53B3R4R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CYCLOMETHICONE (UNII: NMQ347994Z) GLYCERIN (UNII: PDC6A3C0OX) NIACINAMIDE (UNII: 25X51I8RD4) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) PENTYLENE GLYCOL (UNII: 50C1307PZG) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) ISOEICOSANE (UNII: AR294KAG3T) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) RICE BRAN OIL (UNII: LZO6K1506A) CORN OIL (UNII: 8470G57WFM) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A) SUNFLOWER SEED (UNII: R9N3379M4Z) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALUMINUM OXIDE (UNII: LMI26O6933) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ADENOSINE (UNII: K72T3FS567) ORANGE OIL (UNII: AKN3KSD11B) DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49404-139-02 1 in 1 CARTON 06/18/2019 1 NDC:49404-139-01 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 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(49404-139)
