DR.JART PREMIUM BEAUTY BALM MEDIUM-TAN- zinc oxide, titanium dioxide, octinoxate, octisalate cream

Dr.Jart Premium Beauty Balm Medium-Tan by

Drug Labeling and Warnings

Dr.Jart Premium Beauty Balm Medium-Tan by is a Otc medication manufactured, distributed, or labeled by Have & Be Co., Ltd., Estee Lauder Companies Inc., HK Kolmar Canada, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

OCTINOXATE 6.8%
OCTISALATE 4.5%
TITANIUM DIOXIDE 4.8%
ZINC OXIDE 5.0%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

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

For external use only.
Do not use on damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove.
Stop using and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

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

Protect the product in this container from excessive heat and direct sunlight

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.JART PREMIUM BEAUTY BALM MEDIUM-TAN 
zinc oxide, titanium dioxide, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49404-303
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)
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)
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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49404-303-01	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 Drug	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(49404-303)