| NDC | 43419-730-19, 43419-731-19 |
| Set ID | dbfa475a-abe8-45f0-a962-92e023fcecc1 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | AMOREPACIFIC CORPORATION |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENTS
- PURPOSE
-
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
-
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
- PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - No. 1 Brightening BB
- PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - No. 2 Natural BB
-
INGREDIENTS AND APPEARANCE
LANEIGE SNOW BB NO.1 BRIGHTENING BB
octinoxate, titanium dioxide, and zinc oxide creamProduct 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 02/23/2022 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 02/23/2022 LANEIGE SNOW BB NO.2 NATURAL BB
octinoxate, titanium dioxide, and zinc oxide creamProduct 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 02/23/2022 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 02/23/2022 Labeler - AMOREPACIFIC CORPORATION (631035289) Establishment Name Address ID/FEI Business Operations AMOREPACIFIC CORPORATION 694894112 manufacture(43419-730, 43419-731)
