Dr. Jart DIS-A-PORE Beauty Balm by Have and Be Co., Ltd. / Cosmax, Inc. 49404-202_Deactivation

Dr. Jart DIS-A-PORE Beauty Balm by

Drug Labeling and Warnings

Dr. Jart DIS-A-PORE Beauty Balm by is a Otc medication manufactured, distributed, or labeled by Have and Be Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DR. JART DIS-A-PORE BEAUTY BALM- titanium dioxide, octinoxate, zinc oxide emulsion 
Have and 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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49404-202_Deactivation

Titanium Dioxide 9.455%

Octinoxate 4.000%

Zinc Oxide 0.980%

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

• 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
Cyclomethicone 5
Dimethicone
Butylene Glycol
Niacinamide
Pentylene Glycol
Disteardimonium Hectorite
Cyclomethicone
C30-45 Alkyl Methicone
Methyl Methacrylate
Ferric Oxide Red
Triethoxycaprylylsilane
Aluminum Hydroxide
Stearic Acid
Ethylhexylglycerin
Adenosine
Disodium Edta-Copper
Cananga Odorata Flower
Chamaecyparis Obtusa Wood Oil
Lavender Oil
Rosemary Oil
Mentha X Rotundifolia Leaf
Chamomile Flower Oil
Peppermint Oil
Hibiscus Sabdariffa Flower
Jasminum Officinale Flower
Argania Spinosa Seed
Sodium Cocoyl Glutamate
Rosa Multiflora Fruit
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked
Propyl Gallate

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

DR. JART DIS-A-PORE BEAUTY BALM 
titanium dioxide, octinoxate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49404-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.7275 mg  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.49 mg  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NIACINAMIDE (UNII: 25X51I8RD4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CYCLOMETHICONE (UNII: NMQ347994Z)
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)
METHYL METHACRYLATE (UNII: 196OC77688)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
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)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
PROPYL GALLATE (UNII: 8D4SNN7V92)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49404-202-02	1 in 1 BOX	03/01/2014	12/19/2019
1	NDC: 49404-202-01	50 mL in 1 TUBE; 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	03/01/2014	12/19/2019

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(49404-202)

Revised: 12/2019

Document Id: 9a13e6b8-7480-9cd4-e053-2a95a90afafb

34390-5

Set id: 57d1d256-4e1f-45df-992b-4c47f10ceb60

Version: 8

Effective Time: 20191219

 

Have and Be Co., Ltd.