Label: DR.JART PREMIUM BEAUTY BALM LIGHT MEDIUM-MEDIUM- zinc oxide, titanium dioxide, octinoxate, octisalate cream
- NDC Code(s): 49404-302-01
- Packager: Have & Be Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 August 11, 2023
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- 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
■ 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, TITANIUM DIOXIDE(CI 77891), PEG-10 DIMETHICONE, TALC, C12-15 ALKYL BENZOATE, HEXYL LAURATE, DIPHENYLSILOXY PHENYL TRIMETHICONE, NIACINAMIDE, DIPROPYLENE GLYCOL, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DIMETHICONE, IRON OXIDES(CI 77492), TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, IRON OXIDES(CI 77491), METHICONE, IRON OXIDES(CI 77499), POLYGLYCERYL-6 POLYRICINOLEATE, TRIHYDROXYSTEARIN, ETHYLHEXYLGLYCERIN, ADENOSINE, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, 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, 1,2-HEXANEDIOL, PALMITOYL TRIPEPTIDE-5, POLYSORBATE 80, PLATINUM POWDER, PALMITOYL HEXAPEPTIDE-12
- OTHER SAFETY INFORMATION
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
DR.JART PREMIUM BEAUTY BALM LIGHT MEDIUM-MEDIUM
zinc oxide, titanium dioxide, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49404-302 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 48 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 50 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 68 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) CYCLOMETHICONE 6 (UNII: XHK3U310BA) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) TALC (UNII: 7SEV7J4R1U) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) 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) PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PLATINUM (UNII: 49DFR088MY) PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49404-302-01 1 in 1 CARTON 08/11/2023 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 final M020 08/11/2023 Labeler - Have & Be Co., Ltd. (690400408) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations HK Kolmar Canada, Inc 243501959 manufacture(49404-302)
