Sulwhasoo Lumitouch Twincake SPF25, PA plus plus

Dosage form: cream
Ingredients: OCTINOXATE 0.352g in 11g, TITANIUM DIOXIDE 1.533g in 11g, ZINC OXIDE 0.216g in 11g
Labeler: AMOREPACIFIC CO.
NDC Code: 43419-719

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.

Sulwhasoo
LUMITOUCH TWINCAKE

SPF 25, PA++ No. 25 Dark Beige

WARNING LABEL

FOR EXTERNAL USE ONLY.

AVOID CONTACT WITH EYES.

DISCONTINUE USE IF SIGNS OF IRRITATION APPEAR.

KEEP OUT OF REACH OF CHILDREN.

ACTIVE INGREDIENTS

ETHYLHEXYL METHOXYCINNAMATE 3.20%, TITANIUM DIOXIDE 13.932%, ZINC OXIDE 1.96%

INGREDIENTS

TALC, MICA, TITANIUM DIOXIDE, SILICA, TRIOCTYLDODECYL CITRATE, ETHYLHEXYL METHOXYCINNAMATE, NYLON-12, BORON NITRIDE, ZINC OXIDE, DIMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, METHICONE, TRIETHOXYCAPRYLYLSILANE, ETHYLHEXYLGLYCERIN, ALUMINUM HYDROXIDE, GLYCERYL CAPRYLATE, ACRYLATES/TRIDECYL ACRYLATE/TRIETHOXYSILYL-PROPYL METHACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, DIOSCOREA JAPONICA ROOT EXTRACT, BARIUM SULFATE, BUTYLENE GLYCOL, DIMETHICONOL, WATER, GARDENIA FLORIDA FRUIT EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, CAPSICUM ANNUUM FRUIT EXTRACT, POLYGONUM TINCTORIUM LEAF EXTRACT, CHRYSANTHEMUM MORIFOLIUM FLOWER EXTRACT, CITRUS UNSHIU PEEL EXTRACT, CORNUS OFFICINALIS FRUIT EXTRACT, POLYGONATUM OFFICINALE RHIZOME/ROOT EXTRACT, REHMANNIA GLUTINOSA ROOT EXTRACT, LILIUM TIGRINUM FLOWER/LEAF/STEM EXTRACT, PAEONIA ALBIFLORA ROOT EXTRACT, NELUMBO NUCIFERA SEED EXTRACT, ADENOPHORA STRICTA ROOT EXTRACT, COIX LACRYMA-JOBI MA-YUEN SEED EXTRACT, HONEY, LYCIUM CHINENSE ROOT EXTRACT, PAEONIA SUFFRUTICOSA ROOT EXTRACT, ANGELICA TENUISSIMA ROOT EXTRACT, ANGELICA ACUTILOBA ROOT EXTRACT, TRICHOSANTHES KIRILOWI ROOT EXTRACT, MAGNESIUM MYRISTATE, GLYCERIN, NELUMBO NUCIFERA LEAF EXTRACT, TERMINALIA CHEBULA FRUIT EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, IRON OXIDES (CI 77491, CI 77492, CI 77499), ULTRAMARINES, FRAGRANCE

0.4 oz. e / 11 g

AMOREPACIFIC US INC.
270 Sylvan Ave. #255
Englewood Cliffs, NJ 07632

MADE IN KOREA (1630)

PRINCIPAL DISPLAY PANEL - 11 g Jar Carton

Sulwhasoo

LUMITOUCH TWINCAKE

SPF25, PA++

0.4 oz. e / 11 g

SULWHASOO LUMITOUCH   TWINCAKE SPF25, PA PLUS PLUS
octinoxate, titanium dioxide, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-719
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE0.352 g  in 11 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE1.533 g  in 11 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.216 g  in 11 g
Inactive Ingredients
Ingredient NameStrength
TALC 
MICA 
SILICON DIOXIDE 
CITRIC ACID MONOHYDRATE 
BORON 
DIMETHICONE 
OCTYLTRIETHOXYSILANE 
ETHYLHEXYLGLYCERIN 
ALUMINUM HYDROXIDE 
GLYCERYL CAPRYLATE 
BARIUM SULFATE 
BUTYLENE GLYCOL 
WATER 
GREEN TEA LEAF 
PAPRIKA OIL 
CHRYSANTHEMUM X MORIFOLIUM FLOWER 
TANGERINE 
FRUIT 
REHMANNIA GLUTINOSA ROOT 
LILIUM TIGRINUM 
PAEONIA LACTIFLORA ROOT 
NELUMBO NUCIFERA SEED 
HONEY 
LYCIUM CHINENSIS FRUCTUS 
TRICHOSANTHES KIRILOWII ROOT 
MAGNESIUM 
GLYCERIN 
SCUTELLARIA LATERIFLORA TOP 
Packaging
#Item CodePackage Description
1NDC:43419-719-2811 g in 1 JAR
2NDC:43419-719-2911 g in 1 JAR
3NDC:43419-719-3011 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/01/2010
Labeler - AMOREPACIFIC CO. (687995683)
Establishment
NameAddressID/FEIOperations
AMOREPACIFIC687995683MANUFACTURE

Revised: 08/2010
 
AMOREPACIFIC CO.

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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