DR.JART DIS-A-PORE BEAUTY BALM 01- titanium dioxide, octinoxate, octisalate cream

Dr.Jart Dis-A-Pore Beauty Balm 01 by

Drug Labeling and Warnings

Dr.Jart Dis-A-Pore Beauty Balm 01 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 15.97%

Octinoxate 4.99%

Octisalate 3.00%

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, DIMETHICONE/VINYL DIMETHICONECROSSPOLYMER, ISODODECANE, LAURYL PEG-10TRIS(TRIMETHYLSILOXY)SILYLETHYLDIMETHICONE, DIMETHICONE, NIACINAMIDE, METHYLPROPANEDIOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, IRON OXIDES(CI 77492), SYNTHETIC FLUORPHLOGOPITE, DISTEARDIMONIUM HECTORITE, GLYCERIN, MAGNESIUM SULFATE, ISOPROPYL PALMITATE, HDI/TRIMETHYLOL HEXYLLACTONECROSSPOLYMER, TRIETHOXYCAPRYLYLSILANE, DIPENTAERYTHRITYLHEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, POLYGLYCERYL-4 ISOSTEARATE, ALUMINUM HYDROXIDE, IRON OXIDES(CI 77491), CAPRYLYL GLYCOL, IRON OXIDES(CI 77499), GLYCERYL CAPRYLATE, TRIHYDROXYSTEARIN, ETHYLHEXYLGLYCERIN, PINUS SYLVESTRIS LEAF OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT)FRUIT OIL, SILICA, ADENOSINE, BHT, TOCOPHEROL, BUTYLENE GLYCOL, ALCOHOL, 1,2-HEXANEDIOL, LECITHIN, PISTACIA LENTISCUS (MASTIC) GUM

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.JART DIS-A-PORE BEAUTY BALM 01 
titanium dioxide, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49404-145
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.388 mg  in 40 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.996 mg  in 40 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.2 mg  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
NIACINAMIDE (UNII: 25X51I8RD4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49404-145-02	1 in 1 CARTON	11/07/2019
1	NDC: 49404-145-01	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	11/07/2019

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(49404-145)