SULWHASOO SNOWISE BRIGHTENING BB BASE NO.1- octinoxate, titanium dioxide, and zinc oxide lotion SULWHASOO SNOWISE BRIGHTENING BB BASE NO.2- octinoxate, titanium dioxide, and zinc oxide lotion

SULWHASOO SNOWISE BRIGHTENING BB BASE by

Drug Labeling and Warnings

SULWHASOO SNOWISE BRIGHTENING BB BASE by is a Otc medication manufactured, distributed, or labeled by AMOREPACIFIC Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENTS

ETHYLHEXYL METHOXYCINNAMATE 7%, TITANIUM DIOXIDE 3.32%, ZINC OXIDE 7.84%

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

INACTIVE INGREDIENTS

ARTEMISIA VULGARIS EXTRACT, ANGELICA ACUTILOBA ROOT EXTRACT, CNIDIUM OFFICINALE ROOT EXTRACT, CYCLOPENTASILOXANE, METHYL TRIMETHICONE, BUTYLENE GLYCOL, CYCLOHEXASILOXANE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, NIACINAMIDE, PEG-10 DIMETHICONE, DIMETHICONE, 1,2- HEXANEDIOL, ANGELICA TENUISSIMA ROOT EXTRACT, CHRYSANTHEMUM MORIFOLIUM FLOWER EXTRACT, CITRUS UNSHIU PEEL EXTRACT, HONEY, MORINDA CITRIFOLIA FRUIT EXTRACT, ADENOPHORA STRICTA ROOT EXTRACT, DIMETHICONE/PEG-10/15 CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER, METHOXY PEG-114/POLYEPSILON CAPROLACTONE, PAEONIA SUFFRUTICOSA ROOT EXTRACT, LILIUM TIGRINUM FLOWER/LEAF/STEM EXTRACT, OLDENLANDIA DIFFUSA EXTRACT, SODIUM CHLORIDE, STEARIC ACID, ALUMINUM HYDROXIDE, NELUMBO NUCIFERA GERM EXTRACT, POLYGONATUM OFFICINALE RHIZOME/ROOT EXTRACT, COIX LACRYMAJOBI MA-YUEN SEED EXTRACT, PANAX GINSENG ROOT EXTRACT, PAEONIA ALBIFLORA ROOT EXTRACT, WATER, LYCIUM CHINENSE ROOT EXTRACT, REHMANNIA GLUTINOSA ROOT EXTRACT, TRIETHOXYCAPRYLYLSILANE, TRICALCIUM PHOSPHATE, POLOXAMER 184, POLYSORBATE 80, POLYSILICONE-11, HYDROGENATED LECITHIN, YEAST EXTRACT, DISODIUM EDTA, PHENOXYETHANOL, FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES (CI 77491, CI 77492, CI 77499)

OTHER INFORMATION

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

SPL UNCLASSIFIED SECTION

AMOREPACIFIC INC. DIST
NEW YORK, NY 10012

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton (NO.1 BLOOMING BEIGE)

Sulwhasoo

SNOWISE BRIGHTENING BB BASE

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton (NO.2 NATURAL BEIGE)

Sulwhasoo

SNOWISE BRIGHTENING BB BASE

INGREDIENTS AND APPEARANCE

SULWHASOO SNOWISE BRIGHTENING BB BASE  NO.1
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.1 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.996 g  in 30 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.352 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
NIACINAMIDE (UNII: 25X51I8RD4)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
SCLEROMITRION DIFFUSUM (UNII: 291PPU5K9I)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
NONI FRUIT (UNII: 7829X3G2X5)
ASIAN GINSENG (UNII: CUQ3A77YXI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-005-08	30 mL in 1 TUBE; Type 0: Not a Combination Product	10/05/2011
2	NDC: 43419-005-14	5 mL in 1 TUBE; Type 0: Not a Combination Product	10/05/2011	08/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/05/2011

SULWHASOO SNOWISE BRIGHTENING BB BASE  NO.2
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.1 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.996 g  in 30 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.352 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
NIACINAMIDE (UNII: 25X51I8RD4)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
SCLEROMITRION DIFFUSUM (UNII: 291PPU5K9I)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
NONI FRUIT (UNII: 7829X3G2X5)
ASIAN GINSENG (UNII: CUQ3A77YXI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-006-08	30 mL in 1 TUBE; Type 0: Not a Combination Product	10/05/2011
2	NDC: 43419-006-14	5 mL in 1 TUBE; Type 0: Not a Combination Product	10/05/2011	08/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/05/2011

Labeler - AMOREPACIFIC Corporation (631035289)

Establishment
Name	Address	ID/FEI	Business Operations
AMOREPACIFIC Corporation		694894112	manufacture(43419-005, 43419-006)