Dr.Jart Dis-A-Pore Beauty Balm 02 MEDIUM-DEEP by Have & Be Co., Ltd. / Cosmax, Inc. 49404-126_Deactivation

Dr.Jart Dis-A-Pore Beauty Balm 02 MEDIUM-DEEP by

Drug Labeling and Warnings

Dr.Jart Dis-A-Pore Beauty Balm 02 MEDIUM-DEEP by is a Otc medication manufactured, distributed, or labeled by Have & Be Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DR.JART DIS-A-PORE BEAUTY BALM 02 MEDIUM-DEEP- titanium dioxide, octinoxate, zinc oxide 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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49404-126_Deactivation

Ethylhexyl Methoxycinnamate 4.00%
Titanium Dioxide 9.453%
Zinc Oxide 0.980%

Sunscreen

Helps prevent sunburn

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

Apply liberally 15 minutes before sun exposure.

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hgours.

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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

Ask a doctor to use for children under 6 months

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, Dimethicone, PEG-10 Dimethicone, Iron Oxides, Butylene Glycol, Niacinamide, Pentylene Glycol, Polymethylsilsesquioxane, Disteardimonium Hectorite, Cyclopentasiloxane, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Dimethicone Crosspolymer, Methylpropanediol, Magnesium Sulfate, Phenoxyethanol, Cetyl PEG/PPG-10/1 Dimethicone, Phenyl Trimethicone, Methyl Methacrylate Crosspolymer, Triethoxycaprylylsilane, Aluminum Hydroxide, Stearic Acid, Ethylhexylglycerin, Butyl Avocadate, Adenosine, Disodium EDTA, Cananga Odorata Flower Extract, Chamaecyparis Obtusa Oil, Lavandula Angustifolia (Lavender) Flower Water, Rosmarinus Officinalis (Rosemary) Leaf Water, Mentha Rotundifolia Leaf Extract, Chamomilla Recutita (Matricaria) Flower Water, Mentha Piperita (Peppermint) Leaf Water, Hibiscus Sabdariffa Flower Extract, Jasminum Officinale (Jasmine) Flower Water, Argania Spinosa Kernel Extract, Sodium Cocoyl Glutamate, Rosa Multiflora Fruit Extract, Carbomer, Propyl Gallate

image description

DR.JART DIS-A-PORE BEAUTY BALM 02 MEDIUM-DEEP 
titanium dioxide, octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49404-126
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.73 mg  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 mg  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.49 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ADENOSINE (UNII: K72T3FS567)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)  
CHAMAECYPARIS OBTUSA WOOD OIL (UNII: P2OMP71Y62)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
MENTHA X ROTUNDIFOLIA LEAF (UNII: K59TXG2L3U)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)  
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
ROSA MULTIFLORA FRUIT (UNII: EZ5DSL4T27)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49404-126-021 in 1 CARTON12/30/201512/19/2019
1NDC: 49404-126-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/30/201512/19/2019
Labeler - Have & Be Co., Ltd. (690400408)
Registrant - Have & Be Co., Ltd. (690400408)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(49404-126)

Revised: 12/2019
 
Have & Be Co., Ltd.