LANEIGE SNOW BB NO.1 BRIGHTENING BB- octinoxate, titanium dioxide, and zinc oxide cream LANEIGE SNOW BB NO.2 NATURAL BB- octinoxate, titanium dioxide, and zinc oxide cream

LANEIGE Snow BB No.2 Natural BB by

Drug Labeling and Warnings

LANEIGE Snow BB No.2 Natural 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 5.81%

ZINC OXIDE 1.96%

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

WATER, METHYL TRIMETHICONE, CYCLOPENTASILOXANE, TITANIUM DIOXIDE (CI 77891), NEOPENTYL GLYCOL DIHEPTANOATE, CYCLOHEXASILOXANE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ARBUTIN, BUTYLENE GLYCOL, DISTEARDIMONIUM HECTORITE, SODIUM CHLORIDE, LAURYL PEG/PPG-18/18 METHICONE, PEG-10 DIMETHICONE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, IRON OXIDES (CI 77492), ALUMINUM HYDROXIDE, STEARIC ACID, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, METHYLMETHACRYLATE CROSSPOLYMER, FRAGRANCE, PHENOXYETHANOL, IRON OXIDES (CI 77491), CAPRYLYL GLYCOL, TRIETHOXYCAPRYLYLSILANE, IRON OXIDES (CI 77499), DISODIUM EDTA, CRATAEGUS MONOGYNA FRUIT EXTRACT, GLYCERIN, ADENOSINE, BEHENYL ALCOHOL, ULTRAMARINES (CI 77007), POLYGLYCERYL-10 PENTASTEARATE, CETEARYL ALCOHOL, SODIUM STEAROYL LACTYLATE, CETYL ETHYLHEXANOATE, LIMNANTHES ALBA (MEADOWFOAM) SEED OIL, CETEARYL GLUCOSIDE, HYDROGENATED LECITHIN

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - No. 1 Brightening BB

Snow BB
Cream
Broad Spectrum
SPF 30
Sunscreen

No. 1
Brightening BB

40 mL / 1.3 FL. OZ. e

LANEIGE

PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - No. 2 Natural BB

Snow BB
Cream
Broad Spectrum
SPF 30
Sunscreen

No. 2
Natural BB

40 mL / 1.3 FL. OZ. e

LANEIGE

INGREDIENTS AND APPEARANCE

LANEIGE SNOW BB NO.1 BRIGHTENING BB 
octinoxate, titanium dioxide, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-730
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.8 g  in 40 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.324 g  in 40 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.784 g  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
ARBUTIN (UNII: C5INA23HXF)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
PEG-14 DIMETHICONE (UNII: G7DL1Y4G26)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CRATAEGUS MONOGYNA FRUIT (UNII: KJI2JZT1TS)
GLYCERIN (UNII: PDC6A3C0OX)
ADENOSINE (UNII: K72T3FS567)
DOCOSANOL (UNII: 9G1OE216XY)
ULTRAMARINE BLUE (UNII: I39WR998BI)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-730-19	1 in 1 CARTON	04/21/2014
1		40 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	04/21/2014

LANEIGE SNOW BB NO.2 NATURAL BB 
octinoxate, titanium dioxide, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-731
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.8 g  in 40 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.324 g  in 40 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.784 g  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
ARBUTIN (UNII: C5INA23HXF)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
PEG-14 DIMETHICONE (UNII: G7DL1Y4G26)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CRATAEGUS MONOGYNA FRUIT (UNII: KJI2JZT1TS)
GLYCERIN (UNII: PDC6A3C0OX)
ADENOSINE (UNII: K72T3FS567)
DOCOSANOL (UNII: 9G1OE216XY)
ULTRAMARINE BLUE (UNII: I39WR998BI)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-731-19	1 in 1 CARTON	04/21/2014
1		40 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	04/21/2014

Labeler - AMOREPACIFIC CORPORATION (631035289)

Establishment
Name	Address	ID/FEI	Business Operations
AMOREPACIFIC CORPORATION		694894112	MANUFACTURE(43419-730, 43419-731)