Dr.Jart Every Sun Day Sunscreen SPF 50 by Have & Be Co., Ltd. / Kolmar Korea Co., Ltd. 49404-130_Deactivation

Dr.Jart Every Sun Day Sunscreen SPF 50 by

Drug Labeling and Warnings

Dr.Jart Every Sun Day Sunscreen SPF 50 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]

DR.JART EVERY SUN DAY SUNSCREEN SPF 50- zinc oxide, octinoxate, octisalate, titanium dioxide 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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49404-130_Deactivation

ZINC OXIDE 12.660%

OCTINOXATE 6.800%

OCTISALATE 4.500%

TITANIUM DIOXIDE 2.490%

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, Cyclopentasiloxane, Dipropylene Glycol, Dicaprylyl Carbonate, Butyloctyl Salicylate, Peg-10 Dimethicone, Caprylyl Methicone, Glycerin, Disteardimonium Hectorite, Dimethicone, Viscum Album (Mistletoe) Leaf Extract, Centella Asiatica Extract, Portulaca Oleracea Extract, Magnesium Sulfate, Mica, Silica, Phenoxyethanol, Polymethylsilsesquioxane, Aluminum Hydroxide, Triethoxycaprylylsilane, Dimethicone/Vinyl Dimethiconecrosspolymer, Aluminum Stearate, Caprylyl Glycol, Polyglyceryl-6 Polyricinoleate, Vinyl Dimethicone/Methiconesilsesquioxane Crosspolymer, Microcrystalline Cellulose, Glyceryl Caprylate, Lavandula Angustifolia (Lavender) Oil, Iron Oxides, Rose Flower Oil, Polyurethane-11, Juniperus Mexicana Oil, Cellulose Gum, Sodium Hyaluronate, Aminopropyl Dimethicone, Calendula Officinalis Flower, Aloe Barbadensis Leaf Extract

image description

DR.JART EVERY SUN DAY SUNSCREEN SPF 50 
zinc oxide, octinoxate, octisalate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49404-130
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION6.33 mg  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.4 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.25 mg  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.25 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
GLYCERIN (UNII: PDC6A3C0OX)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
PURSLANE (UNII: M6S840WXG5)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
MICA (UNII: V8A1AW0880)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ROSA RUGOSA FLOWER BUD (UNII: TZ0BE8I3MW)  
JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49404-130-021 in 1 CARTON01/25/201612/19/2019
1NDC: 49404-130-0150 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 finalpart35201/25/201612/19/2019
Labeler - Have & Be Co., Ltd. (690400408)
Registrant - Have & Be Co., Ltd. (690400408)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(49404-130)

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