DR. JART BB GET READY- octinoxate, zinc oxide, octisalate, titanium dioxide 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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Drug Facts

Octinoxate 7.000%
Zinc Oxide 4.900%
Octisalate 4.500%
Titanium Dioxide 2.905%

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
Cyclomethicone 6
Glycerin
Dimethicone
Niacinamide
Dipropylene Glycol
Peg-10 Dimethicone (600 Cst)
Cetyl Peg/Ppg-10/1 Dimethicone (Hlb 2)
Magnesium Sulfate
Disteardimonium Hectorite
Ferric Oxide Red
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle)
Aluminum Hydroxide
Stearic Acid
Phenoxyethanol
Glyceryl Caprylate
Caprylyl Glycol
Talc
Caffeine
Adenosine
Lavandula Angustifolia Whole
Butylene Glycol
Sodium Chloride
Sucrose
Salix Nigra Bark
Serine
Arginine
Pidolic Acid
Alanine
Polyquaternium-51 (2-Methacryloyloxyethyl Phosphorylcholine/N-Butyl Methacrylate; 3:7)
Melissa Officinalis Leaf
Malva Sylvestris Flowering Top
Achillea Millefolium
Alchemilla Xanthochlora Flowering Top
Primula Veris
Mentha Piperita Leaf
Threonine
Benzyl Alcohol
Purslane
Dehydroacetic Acid

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 BB GET READY
octinoxate, zinc oxide, octisalate, titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49404-205
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.1 mg in 30 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.47 mg in 30 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.35 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.8715 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
Glycerin (UNII: PDC6A3C0OX)
Dimethicone (UNII: 92RU3N3Y1O)
Niacinamide (UNII: 25X51I8RD4)
Dipropylene Glycol (UNII: E107L85C40)
FERRIC OXIDE RED (UNII: 1K09F3G675)
Caprylyl Glycol (UNII: 00YIU5438U)
Talc (UNII: 7SEV7J4R1U)
Butylene Glycol (UNII: 3XUS85K0RA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49404-205-02	1 in 1 CARTON	05/25/2017	06/08/2017
1	NDC:49404-205-01	30 mL in 1 TUBE; 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	05/25/2017	06/08/2017

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Cosmax, Inc.		689049693	manufacture(49404-205)

Revised: 6/2017

Document Id: aacb3728-31c3-4c91-8ebb-59d714a19e3f

Set id: ab45ae2e-dc92-44cb-bf14-872f2659effa

Version: 9

Effective Time: 20170608

Have and Be Co., Ltd.