DR.JART EVERY SUN DAY SUN FLUID- homosalate, octinoxate, octisalate, octocrylene, avobenzone liquid

Dr.Jart Every Sun Day Sun Fluid by

Drug Labeling and Warnings

Dr.Jart Every Sun Day Sun Fluid 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

Homosalate 9.00%

Octinoxate 6.80%

Octisalate 4.50%

Octocrylene 4.00%

Avobenzone 2.90%

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, PROPANEDIOL, ALCOHOL, BENZOTRIAZOLYL DODECYL P-CRESOL, PENTYLENE GLYCOL, 1,2-HEXANEDIOL, SILICA, DIMETHICONE/VINYL DIMETHICONECROSSPOLYMER, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VPCOPOLYMER, STYRENE/ACRYLATES COPOLYMER, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ETHYLHEXYLGLYCERIN, HYDROXYPROPYL METHYLCELLULOSESTEAROXY ETHER, POLYACRYLATE CROSSPOLYMER-6, BUTYLENE GLYCOL, BHT, T-BUTYL ALCOHOL, TOCOPHEROL

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.JART EVERY SUN DAY SUN FLUID 
homosalate, octinoxate, octisalate, octocrylene, avobenzone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49404-144
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 mg  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.8 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 mg  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 mg  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.9 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
ALCOHOL (UNII: 3K9958V90M)
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
LAVENDER OIL (UNII: ZBP1YXW0H8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49404-144-02	1 in 1 CARTON	10/31/2019
1	NDC: 49404-144-01	100 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	10/31/2019

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(49404-144)