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 
AMOREPACIFIC Corporation

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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Sulwhasoo

SNOWISE BRIGHTENING BB BASE

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

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. 1 BLOOMING BEIGE)

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

Sulwhasoo

SNOWISE BRIGHTENING BB BASE

Principal Display Panel  - 30 ml Tube Carton (NO.2 NATURAL BEIGE)
SULWHASOO SNOWISE BRIGHTENING BB BASE  NO.1
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.1 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.996 g  in 30 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.352 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-005-0830 mL in 1 TUBE; Type 0: Not a Combination Product10/05/201107/07/2020
2NDC:43419-005-145 mL in 1 TUBE; Type 0: Not a Combination Product10/05/201108/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/05/201107/07/2020
SULWHASOO SNOWISE BRIGHTENING BB BASE  NO.2
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.1 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.996 g  in 30 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.352 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-006-0830 mL in 1 TUBE; Type 0: Not a Combination Product10/05/201107/07/2020
2NDC:43419-006-145 mL in 1 TUBE; Type 0: Not a Combination Product10/05/201108/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/05/201107/07/2020
Labeler - AMOREPACIFIC Corporation (631035289)
Establishment
NameAddressID/FEIBusiness Operations
AMOREPACIFIC Corporation694894112manufacture(43419-005, 43419-006)

Revised: 7/2020
 
AMOREPACIFIC Corporation