Dr.Jart Every Sun Day Sun Fluid SPF 30 by Have & Be Co., Ltd. / Cosmecca Korea Co., Ltd. 49404-129_Deactivation

Dr.Jart Every Sun Day Sun Fluid SPF 30 by

Drug Labeling and Warnings

Dr.Jart Every Sun Day Sun Fluid SPF 30 by is a Otc medication manufactured, distributed, or labeled by Have & Be Co., Ltd., Cosmecca Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DR.JART EVERY SUN DAY SUN FLUID SPF 30- homosalate, octocrylene, octisalate, avobenzone 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.

----------

49404-129_Deactivation

HOMOSALATE 10.000%

OCTOCRYLENE 5.000%

OCTISALATE 5.000%

AVOBENZONE 3.000%

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 a.m.-2 p.m.
– 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, Dipropylene Glycol, Butylene Glycol, Methyl Methacrylate Crosspolymer, Ethylhexyl Methoxycrylene, Dimethicone, Bis-PEG/PPG-20/5 PEG/PPG-20/5 Dimethicone, Methoxy PEG/PPG-25/4 Dimethicone, Caprylyl Glycol, Caprylic/Capric Triglyceride, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cyclopentasiloxane, Potassium Hydroxide, 1,2-Hexanediol, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ethylhexylglycerin, Citrus Aurantium Dulcis (Orange) Oil, Acrylates/Dimethicone Copolymer, Isohexadecane, Polysorbate 80, Disodium EDTA, Lavandula Angustifolia (Lavender) Oil, Aloe Barbadensis Leaf Extract, Chamaecyparis Obtusa Water, Mentha Piperita (Peppermint) Leaf Extract, Geranium Maculatum Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Santalum Album (Sandalwood) Oil, Rose Flower Oil, Alcohol, Chamomilla Recutita (Matricaria) Flower Oil, Xylitol, Styrax Benzoin Gum, Commiphora Myrrha Oil, Phenoxyethanol, Polyquaternium-7, Acrylamidopropyltrimonium Chloride/Acrylamide Copolymer, Ecklonia cava Extract, Gelidium Cartilagineum Extract, Hizikia Fusiforme Extract, Codium Tomentosum Extract

image description

DR.JART EVERY SUN DAY SUN FLUID SPF 30 
homosalate, octocrylene, octisalate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49404-129
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 mg  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ORANGE OIL (UNII: AKN3KSD11B)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CHAMAECYPARIS OBTUSA WOOD OIL (UNII: P2OMP71Y62)  
MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
GERANIUM MACULATUM ROOT OIL (UNII: H2E371EDYX)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
SANDALWOOD OIL (UNII: X7X01WMQ5F)  
ROSA RUGOSA FLOWER BUD (UNII: TZ0BE8I3MW)  
ALCOHOL (UNII: 3K9958V90M)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
XYLITOL (UNII: VCQ006KQ1E)  
STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)  
MYRRH OIL (UNII: H74221J5J4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
ACRYLAMIDOPROPYLTRIMONIUM CHLORIDE/ACRYLAMIDE COPOLYMER (400 MPA.S) (UNII: 2RX4MI2LCX)  
ECKLONIA CAVA (UNII: UXX2N5V39P)  
GELIDIUM CARTILAGINEUM (UNII: 37LBZ0E1UE)  
SARGASSUM FUSIFORME (UNII: X436TJ4A11)  
CODIUM TOMENTOSUM (UNII: B8B45BRU87)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49404-129-021 in 1 CARTON01/25/201612/19/2019
1NDC: 49404-129-01100 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 finalpart35201/25/201612/19/2019
Labeler - Have & Be Co., Ltd. (690400408)
Registrant - Have & Be Co., Ltd. (690400408)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(49404-129)

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