DR.JART PREMUIM BEAUTY BALM 03 DEEP- octinoxate, octisalate cream
Have & Be Co., Ltd.

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.

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49404-136_Deactivation

Octinoxate 6.79%

Octisalate 4.50%

Sunscreen

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

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

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

WATER
CYCLOPENTASILOXANE
CYCLOHEXASILOXANE
TITANIUM DIOXIDE
ZINC OXIDE
GLYCERIN
TALC
PEG-10 DIMETHICONE
IRON OXIDES
C12-15 ALKYL BENZOATE
NIACINAMIDE
DIPHENYLSILOXY PHENYL TRIMETHICONE
DIPROPYLENE GLYCOL
HEXYL LAURATE
DISTEARDIMONIUM HECTORITE
MAGNESIUM SULFATE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER
DIMETHICONE
TRIETHOXYCAPRYLYLSILANE
PHENOXYETHANOL
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

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

image description

DR.JART PREMUIM BEAUTY BALM 03 DEEP
octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49404-136
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.71 mg in 40 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.8 mg in 40 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ZINC OXIDE (UNII: SOI2LOH54Z)
GLYCERIN (UNII: PDC6A3C0OX)
TALC (UNII: 7SEV7J4R1U)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
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)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PLATINUM (UNII: 49DFR088MY)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49404-136-02	1 in 1 CARTON	01/08/2018	03/27/2020
1	NDC:49404-136-01	40 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/08/2018	03/27/2020

Labeler - Have & Be Co., Ltd. (690400408)

Registrant - Have & Be Co., Ltd. (690400408)

Name	Address	ID/FEI	Business Operations
Establishment
Kolmar Korea Co., Ltd.		689512611	manufacture(49404-136)

Revised: 3/2020

Document Id: a1daa13c-8a88-efb0-e053-2995a90a9fb3

Set id: 82f8def2-679b-4b5f-8a24-b610dbbec4a6

Version: 2

Effective Time: 20200327

Have & Be Co., Ltd.