DR.JART BLACK LABEL DETOX BEAUTY BALM- titanium dioxide, octinoxate, octisalate, zinc oxide cream

Dr.Jart Black Label Detox Beauty Balm by

Drug Labeling and Warnings

Dr.Jart Black Label Detox Beauty Balm by is a Otc medication manufactured, distributed, or labeled by Have & Be Co., Ltd., Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 8.32%

Octinoxate 6.00%

Octisalate 2.00%

Zinc Oxide 1.96%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

If used as directed with other sun protection meausres (see Directions), decreases the risk of skin cancer and early skin aging casued by the sun

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

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
PHENYL TRIMETHICONE
METHYLPROPANEDIOL
CAPRYLIC/CAPRIC TRIGLYCERIDE
CYCLOMETHICONE
GLYCERIN
LAURYL PEG-10TRIS(TRIMETHYLSILOXY)SILYLETHYLDIMETHICONE
NIACINAMID

DIPENTAERYTHRITYL 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

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

You may report a serious adverse event from use of this product to: Report Reaction, LLC PO Box 22 Plainsboro, NJ 08536-0222

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.JART BLACK LABEL DETOX BEAUTY BALM 
titanium dioxide, octinoxate, octisalate, zinc oxide cream

Product 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)