LANEIGE SunScreen Triple

Dosage form: cream
Ingredients: OCTINOXATE 70mg in 1mL, TITANIUM DIOXIDE 58.1mg in 1mL, ZINC OXIDE 19.6g in 1mL
Labeler: AMOREPACIFIC
NDC Code: 43419-811

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.

LANEIGE SunScreen Triple

Drug Facts

ACTIVE INGREDIENTS

ETHYLHEXYL METHOXYCINNAMATE 7%
TITANIUM DIOXIDE 5.81%
ZINC OXIDE 1.96%

PURPOSE

Sunscreen

USE
  • helps prevent sunburn

WARNINGS

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

  • 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 use and ask a doctor if rash occurs

  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS
  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor

INACTIVE INGREDIENTS

WATER, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, BUTYLENE GLYCOL, DICAPRYLYL CARBONATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, SORBITAN ISOSTEARATE, DISTEARDIMONIUM HECTORITE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, SODIUM CHLORIDE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, ALUMINUM HYDROXIDE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, STEARIC ACID, OZOKERITE, CAPRYLYL GLYCOL, SODIUM CITRATE, ETHYLHEXYLGLYCERIN, DISODIUM EDTA, TRIETHOXYCAPRYLYLSILANE, ADENOSINE, MAGNESIUM SULFATE, MANGANESE SULFATE, ZINC SULFATE, FRAGRANCE, TITANIUM DIOXIDE (CI 77891), MICA (CI 77019)

OTHER INFORMATION
  • protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

LANEIGE

SunScreen
Triple

Sunscreen
SPF 40

50 mL / 1.6 FL.OZ. e

LANEIGE SUNSCREEN TRIPLE 
octinoxate, titanium dioxide, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-811
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE70 mg  in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE58.1 mg  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE19.6 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
CYCLOMETHICONE 6 
BUTYLENE GLYCOL 
DICAPRYLYL CARBONATE 
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE 
SORBITAN ISOSTEARATE 
DISTEARDIMONIUM HECTORITE 
SODIUM CHLORIDE 
ALUMINUM HYDROXIDE 
STEARIC ACID 
CAPRYLYL GLYCOL 
SODIUM CITRATE 
ETHYLHEXYLGLYCERIN 
EDETATE DISODIUM 
TRIETHOXYCAPRYLYLSILANE 
ADENOSINE 
MAGNESIUM SULFATE 
MANGANESE SULFATE 
ZINC SULFATE 
MICA 
Packaging
#Item CodePackage Description
1NDC:43419-811-831 TUBE in 1 CARTON
150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/05/2013
Labeler - AMOREPACIFIC (687995683)
Establishment
NameAddressID/FEIOperations
AMOREPACIFIC687995683MANUFACTURE(43419-811)

Revised: 07/2013
 
AMOREPACIFIC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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