DR.JART PREMIUM BEAUTY BALM 03 DEEP- titanium dioxide, zinc oxide, octinoxate, octisalate cream

Dr.Jart Premium Beauty Balm 03 Deep by

Drug Labeling and Warnings

Dr.Jart Premium Beauty Balm 03 Deep 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 5.8%

Zinc Oxide 5.00%

Octinoxate 6.79

Octisalate 4.50%

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
CYCLOHEXASILOXANE
GLYCERIN
TALC
PEG-10 DIMETHICONE
IRON OXIDES(CI 77492)
C12-15 ALKYL BENZOATE
NIACINAMIDE
DIPHENYLSILOXY PHENYL TRIMETHICONE
DIPROPYLENE GLYCOL
HEXYL LAURATE
DISTEARDIMONIUM HECTORITE
MAGNESIUM SULFATE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER
DIMETHICONE
IRON OXIDES(CI 77491)
TRIETHOXYCAPRYLYLSILANE
PHENOXYETHANOL
IRON OXIDES(CI 77499)
METHICONE
POLYGLYCERYL-6 POLYRICINOLEATE
ETHYLHEXYLGLYCERIN
TRIHYDROXYSTEARIN
CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL
ADENOSINE
PINUS SYLVESTRIS LEAF OIL
CITRUS AURANTIFOLIA (LIME) OIL
BHT
EUCALYPTUS GLOBULUS LEAF OIL
CITRUS LIMON (LEMON) PEEL OIL
CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL
ALLANTOIN
GLYCERYL POLYMETHACRYLATE
PROPYLENE GLYCOL
1,2-HEXANEDIOL
PLATINUM POWDER
PALMITOYL TRIPEPTIDE-1
POLYSORBATE 80

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 PREMIUM BEAUTY BALM 03 DEEP 
titanium dioxide, zinc oxide, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49404-141
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.32 mg  in 40 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2 mg  in 40 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.716 mg  in 40 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.8 mg  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
GLYCERIN (UNII: PDC6A3C0OX)
TALC (UNII: 7SEV7J4R1U)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
NIACINAMIDE (UNII: 25X51I8RD4)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
METHICONE (20 CST) (UNII: 6777U11MKT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
ORANGE OIL (UNII: AKN3KSD11B)
ADENOSINE (UNII: K72T3FS567)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
LIME OIL (UNII: UZH29XGA8G)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LEMON OIL (UNII: I9GRO824LL)
BERGAMOT OIL (UNII: 39W1PKE3JI)
ALLANTOIN (UNII: 344S277G0Z)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PLATINUM (UNII: 49DFR088MY)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49404-141-02	1 in 1 CARTON	09/11/2018
1	NDC: 49404-141-01	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	09/11/2018

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(49404-141)