SULWHASOO SNOWISE BRIGHTENING SERUM BB- octinoxate, titanium dioxide, and zinc oxide cream SULWHASOOSNOWISE BRIGHTENING SERUM BB- octinoxate, titanium dioxide, and zinc oxide cream

SulwhasooSNOWISE BRIGHTENING SERUM BB by

Drug Labeling and Warnings

SulwhasooSNOWISE BRIGHTENING SERUM BB 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

USES

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions),decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS

• 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
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months of age: Ask a doctor

INACTIVE INGREDIENTS

OPHIOPOGON JAPONICUS ROOT EXTRACT, GLYCYRRHIZA URALENSIS (LICORICE) ROOT EXTRACT, CYCLOPENTASILOXANE, METHYL TRIMETHICONE, BUTYLENE GLYCOL, PROPYLENE GLYCOL, CYCLOHEXASILOXANE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, NIACINAMIDE, PEG-10 DIMETHICONE, DIMETHICONE, SODIUM CHLORIDE, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, BORON NITRIDE, STEARIC ACID, DIMETHICONE/PEG-10/15 CROSSPOLYMER, TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, POLYSORBATE 80, CAPRYLYL GLYCOL, POLYSILICONE-11, HYDROGENATED LECITHIN, SCLEROTIUM GUM, ETHYLHEXYLGLYCERIN, DISODIUM EDTA, ADENOSINE, WATER, OLDENLANDIA DIFFUSA EXTRACT, YEAST EXTRACT, TRICALCIUM PHOSPHATE, METHOXY PEG-114/POLYEPSILON CAPROLACTONE, 1,2-HEXANEDIOL, HYDROLYZED GINSENG SAPONINS, MORINDA CITRIFOLIA FRUIT EXTRACT, PANAX GINSENG ROOT EXTRACT, FRAGRANCE, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77492, CI 77491, CI 77499)

OTHER INFORMATION

• Protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

Sulwhasoo

SNOWISE

BRIGHTENING
SERUM BB

NO. 1

BLOOMING BEIGE

BROAD SPECTRUM
SPF50+
SUNSCREEN

30 ml / 1.01 fl. oz.

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

Sulwhasoo

SNOWISE

BRIGHTENING
SERUM BB

NO. 2

NATURAL BEIGE

BROAD SPECTRUM
SPF50+
SUNSCREEN

30 ml / 1.01 fl. oz.

INGREDIENTS AND APPEARANCE

SULWHASOO SNOWISE BRIGHTENING SERUM BB 
octinoxate, titanium dioxide, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.4276 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.151376 g  in 30 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.718912 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)
GLYCYRRHIZA URALENSIS (UNII: 42B5YD8F0K)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
NIACINAMIDE (UNII: 25X51I8RD4)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BORON NITRIDE (UNII: 2U4T60A6YD)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ADENOSINE (UNII: K72T3FS567)
WATER (UNII: 059QF0KO0R)
SCLEROMITRION DIFFUSUM (UNII: 291PPU5K9I)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
NONI FRUIT (UNII: 7829X3G2X5)
ASIAN GINSENG (UNII: CUQ3A77YXI)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-029-24	1 in 1 CARTON	05/08/2013
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/08/2013

SULWHASOOSNOWISE BRIGHTENING SERUM BB 
octinoxate, titanium dioxide, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.4276 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.151376 g  in 30 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.718912 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)
GLYCYRRHIZA URALENSIS (UNII: 42B5YD8F0K)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
NIACINAMIDE (UNII: 25X51I8RD4)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BORON NITRIDE (UNII: 2U4T60A6YD)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ADENOSINE (UNII: K72T3FS567)
WATER (UNII: 059QF0KO0R)
SCLEROMITRION DIFFUSUM (UNII: 291PPU5K9I)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
NONI FRUIT (UNII: 7829X3G2X5)
ASIAN GINSENG (UNII: CUQ3A77YXI)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-030-24	1 in 1 CARTON	05/08/2013
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/08/2013

Labeler - AMOREPACIFIC CORPORATION (631035289)

Establishment
Name	Address	ID/FEI	Business Operations
AMOREPACIFIC CORPORATION		694894112	MANUFACTURE(43419-029, 43419-030)