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Sulwhasoo

AMOREPACIFIC

Sulwhasoo LUMITOUCH FOUNDATION (CREAM)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

ACTIVE INGREDIENTS

ETHYLHEXYL METHOXYCINNAMATE 3 %
TITANIUM DIOXIDE 1.66 %
ZINC OXIDE 1.96 %

PURPOSE

Sunscreen

USE

Helps prevent sunburn

WARNINGS

For external use only. Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occur.

When using this product keep out of eyes. Rinse with water to remove.

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

DIRECTIONS

Apply smoothly 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months : ask a doctor

OTHER INFORMATION

Protect this product from excessive heat and direct sun

INACTIVE INGREDIENTS

WATER, BUTYLENE GLYCOL, CYCLOPENTASILOXANE, TRIETHYLHEXANOIN, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, CYCLOHEXASILOXANE, OZOKERITE, DIMETHICONE, SQUALANE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PEG-10 DIMETHICONE, DISTEARDIMONIUM HECTORITE, POLYMETHYL METHACRYLATE, PHENYL TRIMETHICONE, GLYCERYL BEHENATE/EICOSADIOATE, TALC, SODIUM CHLORIDE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, CALCIUM STEARATE, SORBITAN SESQUIOLEATE, ALUMINUM HYDROXIDE, CAPRYLYL GLYCOL, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, POLYSORBATE 80, HYDROGENATED LECITHIN, DISODIUM EDTA, ADENOSINE, SILICA, CHRYSANTHEMUM MORIFOLIUM FLOWER EXTRACT, CITRUS UNSHIU PEEL EXTRACT, DIOSCOREA JAPONICA ROOT EXTRACT, CORNUS OFFICINALIS FRUIT EXTRACT, NELUMBO NUCIFERA SEED EXTRACT, PAEONIA ALBIFLORA ROOT EXTRACT, LILIUM TIGRINUM FLOWER/LEAF/STEM EXTRACT, REHMANNIA GLUTINOSA ROOT EXTRACT, POLYGONATUM OFFICINALE RHIZOME/ROOT EXTRACT, COIX LACRYMA-JOBI MA-YUEN SEED EXTRACT, ADENOPHORA STRICTA ROOT EXTRACT, BARIUM SULFATE, HONEY, LYCIUM CHINENSE ROOT EXTRACT, PAEONIA SUFFRUTICOSA ROOT EXTRACT, CAPSICUM ANNUUM FRUIT EXTRACT, GARDENIA FLORIDA FRUIT EXTRACT, POLYGONUM TINCTORIUM LEAF EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, ANGELICA TENUISSIMA ROOT EXTRACT, TRICHOSANTHES KIRILOWII ROOT EXTRACT, ANGELICA ACUTILOBA ROOT EXTRACT, GLYCERIN, NELUMBO NUCIFERA LEAF EXTRACT, MAGNESIUM MYRISTATE, SCUTELLARIA BAICALENSIS ROOT EXTRACT, TERMINALIA CHEBULA FRUIT EXTRACT, PHENOXYETHANOL, FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES (CI 77491, CI 77492)

AMOREPACIFIC INC. DIST
NEW YORK, NY 10012

PRINCIPAL DISPLAY PANEL - 30 ml Jar Carton No. 21

Sulwhasoo

LUMITOUCH FOUNDATION (CREAM)

Sulwhasoo

PRINCIPAL DISPLAY PANEL - 30 ml Jar Carton No. 23

Sulwhasoo

LUMITOUCH FOUNDATION (CREAM)

Sulwhasoo

PRINCIPAL DISPLAY PANEL - 30 ml Jar Carton No. 25

Sulwhasoo

LUMITOUCH FOUNDATION (CREAM)

Sulwhasoo

Sulwhasoo

OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:43419-002
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.9 g
titanium dioxide 0.498 g
Zinc Oxide Zinc oxide 0.588 g

Inactive Ingredients

Ingredient Name Strength
water
CYCLOMETHICONE 5
BUTYLENE GLYCOL
DIMETHICONE
SQUALANE
FERRIC OXIDE YELLOW
SODIUM CHLORIDE
aluminum hydroxide
ferric oxide red
CALCIUM STEARATE
polysorbate 80
PHENOXYETHANOL
TRIETHOXYCAPRYLYLSILANE
SORBITAN SESQUIOLEATE
CAPRYLYL GLYCOL
STEARIC ACID
FERROSOFERRIC OXIDE
EDETATE DISODIUM
ADENOSINE
CERAMIDE 3
NIACINAMIDE
SILICON DIOXIDE
DIOSCOREA JAPONICA ROOT
BARIUM SULFATE
GREEN TEA LEAF
PERSICARIA TINCTORIA LEAF
GARDENIA JASMINOIDES FRUIT
PAPRIKA
CHRYSANTHEMUM X MORIFOLIUM FLOWER
TANGERINE PEEL
CORNUS OFFICINALIS FRUIT
HYALURONIC ACID
POLYGONATUM ODORATUM ROOT
REHMANNIA GLUTINOSA ROOT
LILIUM LANCIFOLIUM FLOWERING TOP
PAEONIA LACTIFLORA ROOT
NELUMBO NUCIFERA SEED
COIX LACRYMA-JOBI VAR. MA-YUEN SEED
ADENOPHORA STRICTA ROOT
HONEY
LYCIUM CHINENSE ROOT BARK
PAEONIA SUFFRUTICOSA ROOT
LIGUSTICUM TENUISSIMUM ROOT
ANGELICA ACUTILOBA ROOT
TRICHOSANTHES KIRILOWII ROOT
MAGNESIUM MYRISTATE
GLYCERIN
NELUMBO NUCIFERA LEAF
TERMINALIA CHEBULA FRUIT
SCUTELLARIA BAICALENSIS ROOT

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43419-002-04 30 in 1 JAR
2 NDC:43419-002-13 4 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-05-01


Sulwhasoo

OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:43419-003
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.9 g
titanium dioxide 0.498 g
Zinc Oxide Zinc oxide 0.588 g

Inactive Ingredients

Ingredient Name Strength
water
CYCLOMETHICONE 5
BUTYLENE GLYCOL
DIMETHICONE
SQUALANE
FERRIC OXIDE YELLOW
SODIUM CHLORIDE
aluminum hydroxide
ferric oxide red
CALCIUM STEARATE
polysorbate 80
PHENOXYETHANOL
TRIETHOXYCAPRYLYLSILANE
SORBITAN SESQUIOLEATE
CAPRYLYL GLYCOL
STEARIC ACID
FERROSOFERRIC OXIDE
EDETATE DISODIUM
ADENOSINE
CERAMIDE 3
NIACINAMIDE
SILICON DIOXIDE
DIOSCOREA JAPONICA ROOT
BARIUM SULFATE
GREEN TEA LEAF
PERSICARIA TINCTORIA LEAF
GARDENIA JASMINOIDES FRUIT
PAPRIKA
CHRYSANTHEMUM X MORIFOLIUM FLOWER
TANGERINE PEEL
CORNUS OFFICINALIS FRUIT
HYALURONIC ACID
POLYGONATUM ODORATUM ROOT
REHMANNIA GLUTINOSA ROOT
LILIUM LANCIFOLIUM FLOWERING TOP
PAEONIA LACTIFLORA ROOT
NELUMBO NUCIFERA SEED
COIX LACRYMA-JOBI VAR. MA-YUEN SEED
ADENOPHORA STRICTA ROOT
HONEY
LYCIUM CHINENSE ROOT BARK
PAEONIA SUFFRUTICOSA ROOT
LIGUSTICUM TENUISSIMUM ROOT
ANGELICA ACUTILOBA ROOT
TRICHOSANTHES KIRILOWII ROOT
MAGNESIUM MYRISTATE
GLYCERIN
NELUMBO NUCIFERA LEAF
TERMINALIA CHEBULA FRUIT
SCUTELLARIA BAICALENSIS ROOT

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43419-003-04 30 in 1 JAR
2 NDC:43419-003-13 4 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-05-01


Sulwhasoo

OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:43419-007
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.9 g
titanium dioxide 0.498 g
Zinc Oxide Zinc oxide 0.588 g

Inactive Ingredients

Ingredient Name Strength
water
CYCLOMETHICONE 5
BUTYLENE GLYCOL
DIMETHICONE
SQUALANE
FERRIC OXIDE YELLOW
SODIUM CHLORIDE
aluminum hydroxide
ferric oxide red
CALCIUM STEARATE
polysorbate 80
PHENOXYETHANOL
TRIETHOXYCAPRYLYLSILANE
SORBITAN SESQUIOLEATE
CAPRYLYL GLYCOL
STEARIC ACID
FERROSOFERRIC OXIDE
EDETATE DISODIUM
ADENOSINE
CERAMIDE 3
NIACINAMIDE
SILICON DIOXIDE
DIOSCOREA JAPONICA ROOT
BARIUM SULFATE
GREEN TEA LEAF
PERSICARIA TINCTORIA LEAF
GARDENIA JASMINOIDES FRUIT
PAPRIKA
CHRYSANTHEMUM X MORIFOLIUM FLOWER
TANGERINE PEEL
CORNUS OFFICINALIS FRUIT
HYALURONIC ACID
POLYGONATUM ODORATUM ROOT
REHMANNIA GLUTINOSA ROOT
LILIUM LANCIFOLIUM FLOWERING TOP
PAEONIA LACTIFLORA ROOT
NELUMBO NUCIFERA SEED
COIX LACRYMA-JOBI VAR. MA-YUEN SEED
ADENOPHORA STRICTA ROOT
HONEY
LYCIUM CHINENSE ROOT BARK
PAEONIA SUFFRUTICOSA ROOT
LIGUSTICUM TENUISSIMUM ROOT
ANGELICA ACUTILOBA ROOT
TRICHOSANTHES KIRILOWII ROOT
MAGNESIUM MYRISTATE
GLYCERIN
NELUMBO NUCIFERA LEAF
TERMINALIA CHEBULA FRUIT
SCUTELLARIA BAICALENSIS ROOT

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43419-007-04 30 in 1 JAR
2 NDC:43419-007-13 4 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-10-15


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Be sure to consult your doctor before taking any medication!
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