Label: ESIKA- octinoxate and oxybenzone lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-364-01, 13537-364-02, 13537-365-01, 13537-365-02, view more13537-366-01, 13537-366-02, 13537-367-01, 13537-367-02, 13537-368-01, 13537-368-02, 13537-369-01, 13537-369-02, 13537-370-01, 13537-370-02, 13537-371-01, 13537-371-02, 13537-372-01, 13537-372-02, 13537-373-01, 13537-373-02, 13537-374-01, 13537-374-02 - Packager: Ventura Corporation (San Juan, P.R)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 21, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Uses
- Warnings
- Directions
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Inactive Ingredients
Caprylic/capric triglyceride, dipentaerythrityl hexacaprylate/hexacaprate, tridecyl trimellitate, octyldodecanol, vp/hexadecene copolymer, candelilla cera (euphorbia cerifera (candelilla) wax), castor isostearate beeswax succinate, cera alba (beeswax), ozokerite, polyethylene, copernicia cerifera cera (copernicia cerifera (carnauba) wax), tridecyl stearate, silica, glyceryl isostearate, isostearyl alcohol, myristyl myristate, neopentyl glycol dicaprylate/dicaprate, parfum (fragrance), butyrospermum parkii butter (butyrospermum parkii (shea) butter), glycerin, isopropyl myristate, mentha piperita oil (mentha piperita (peppermint) oil), beta-sitosterol, brassica campestris seed oil (brassica campestris (rapeseed) seed oil), sodium saccharin, phenoxyethanol, disteardimonium hectorite, silica silylate, ethyl menthane carboxamide, menthoxypropanediol, microcristallina cera (microcrystalline wax), tocopheryl acetate, methylparaben, petrolatum, phospholipids, bht, mica, schinus terebinthifolius seed extract, propylparaben, cholesterol, butylparaben, ethylparaben, cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, isobutylparaben, glycosphingolipids, dimethicone, trimethylsiloxysilicate. May Contain: diisopropyl dimer dilinoleate, ricinus communis seed oil (ricinus communis (castor) seed oil), hydrogenated polyisobutene, cetyl alcohol, menthyl lactate, propylene glycol, dipalmitoyl hydroxyproline, CI 15850 (red 7 lake), CI 77491 (iron oxides), CI 77492 (iron oxides), CI 77499 (iron oxides), CI 77019 (mica), CI 45410 (red 27 lake), CI 77891 (titanium dioxide ), CI 19140 (yellow 5 lake), CI 45380 (red 21 lake), CI 75470 (carmine), ppg-26-buteth-26, bertholletia excelsa seed oil, orbignya oleifera seed oil, peg-40 hydrogenated castor oil, silica dimethyl silylate, cetearyl ethylhexanoate, aqua (water), hydrogenated coconut oil, oleyl alcohol, cetyl ricinoleate, talc.
- PRINCIPAL DISPLAY PANEL - 4 g Carton - MARRÓN DELICIA
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INGREDIENTS AND APPEARANCE
ESIKA CORE SENSATIONS
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-364 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.065 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.020 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) CASTOR OIL (UNII: D5340Y2I9G) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) OCTYLDODECANOL (UNII: 461N1O614Y) CANDELILLA WAX (UNII: WL0328HX19) CARNAUBA WAX (UNII: R12CBM0EIZ) TRIDECYL STEARATE (UNII: A8OE252M6L) CETYL ALCOHOL (UNII: 936JST6JCN) MENTHYL LACTATE (UNII: 2BF9E65L7I) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82) SHEA BUTTER (UNII: K49155WL9Y) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PEPPERMINT OIL (UNII: AV092KU4JH) BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MICA (UNII: V8A1AW0880) BRAZILIAN PEPPER (UNII: SUG822G7CD) PROPYLPARABEN (UNII: Z8IX2SC1OH) CHOLESTEROL (UNII: 97C5T2UQ7J) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) DIMETHICONE (UNII: 92RU3N3Y1O) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) D&C RED NO. 27 (UNII: 2LRS185U6K) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) WATER (UNII: 059QF0KO0R) COCONUT OIL (UNII: Q9L0O73W7L) OLEYL ALCOHOL (UNII: 172F2WN8DV) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color BROWN (MARRÓN DELICIA) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-364-02 1 in 1 CARTON 1 NDC:13537-364-01 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/02/2011 ESIKA CORE SENSATIONS
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-365 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.065 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.020 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) CASTOR OIL (UNII: D5340Y2I9G) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) OCTYLDODECANOL (UNII: 461N1O614Y) CANDELILLA WAX (UNII: WL0328HX19) CARNAUBA WAX (UNII: R12CBM0EIZ) TRIDECYL STEARATE (UNII: A8OE252M6L) CETYL ALCOHOL (UNII: 936JST6JCN) MENTHYL LACTATE (UNII: 2BF9E65L7I) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82) SHEA BUTTER (UNII: K49155WL9Y) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PEPPERMINT OIL (UNII: AV092KU4JH) BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MICA (UNII: V8A1AW0880) BRAZILIAN PEPPER (UNII: SUG822G7CD) PROPYLPARABEN (UNII: Z8IX2SC1OH) CHOLESTEROL (UNII: 97C5T2UQ7J) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) DIMETHICONE (UNII: 92RU3N3Y1O) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) D&C RED NO. 27 (UNII: 2LRS185U6K) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) WATER (UNII: 059QF0KO0R) COCONUT OIL (UNII: Q9L0O73W7L) OLEYL ALCOHOL (UNII: 172F2WN8DV) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color RED (ROJO AMOROSO) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-365-02 1 in 1 CARTON 1 NDC:13537-365-01 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/02/2011 ESIKA CORE SENSATIONS
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-366 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.065 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.020 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) CASTOR OIL (UNII: D5340Y2I9G) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) OCTYLDODECANOL (UNII: 461N1O614Y) CANDELILLA WAX (UNII: WL0328HX19) CARNAUBA WAX (UNII: R12CBM0EIZ) TRIDECYL STEARATE (UNII: A8OE252M6L) CETYL ALCOHOL (UNII: 936JST6JCN) MENTHYL LACTATE (UNII: 2BF9E65L7I) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82) SHEA BUTTER (UNII: K49155WL9Y) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PEPPERMINT OIL (UNII: AV092KU4JH) BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MICA (UNII: V8A1AW0880) BRAZILIAN PEPPER (UNII: SUG822G7CD) PROPYLPARABEN (UNII: Z8IX2SC1OH) CHOLESTEROL (UNII: 97C5T2UQ7J) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) DIMETHICONE (UNII: 92RU3N3Y1O) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) D&C RED NO. 27 (UNII: 2LRS185U6K) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) WATER (UNII: 059QF0KO0R) COCONUT OIL (UNII: Q9L0O73W7L) OLEYL ALCOHOL (UNII: 172F2WN8DV) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color ORANGE (CIRUELA CONFIDENTE) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-366-02 1 in 1 CARTON 1 NDC:13537-366-01 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/02/2011 ESIKA CORE SENSATIONS
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-367 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.065 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.020 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) CASTOR OIL (UNII: D5340Y2I9G) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) OCTYLDODECANOL (UNII: 461N1O614Y) CANDELILLA WAX (UNII: WL0328HX19) CARNAUBA WAX (UNII: R12CBM0EIZ) TRIDECYL STEARATE (UNII: A8OE252M6L) CETYL ALCOHOL (UNII: 936JST6JCN) MENTHYL LACTATE (UNII: 2BF9E65L7I) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82) SHEA BUTTER (UNII: K49155WL9Y) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PEPPERMINT OIL (UNII: AV092KU4JH) BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MICA (UNII: V8A1AW0880) BRAZILIAN PEPPER (UNII: SUG822G7CD) PROPYLPARABEN (UNII: Z8IX2SC1OH) CHOLESTEROL (UNII: 97C5T2UQ7J) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) DIMETHICONE (UNII: 92RU3N3Y1O) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) D&C RED NO. 27 (UNII: 2LRS185U6K) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) WATER (UNII: 059QF0KO0R) COCONUT OIL (UNII: Q9L0O73W7L) OLEYL ALCOHOL (UNII: 172F2WN8DV) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color RED (FRESA COQUETA) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-367-02 1 in 1 CARTON 1 NDC:13537-367-01 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/02/2011 ESIKA CORE SENSATIONS
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-368 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.065 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.020 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) CASTOR OIL (UNII: D5340Y2I9G) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) OCTYLDODECANOL (UNII: 461N1O614Y) CANDELILLA WAX (UNII: WL0328HX19) CARNAUBA WAX (UNII: R12CBM0EIZ) TRIDECYL STEARATE (UNII: A8OE252M6L) CETYL ALCOHOL (UNII: 936JST6JCN) MENTHYL LACTATE (UNII: 2BF9E65L7I) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82) SHEA BUTTER (UNII: K49155WL9Y) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PEPPERMINT OIL (UNII: AV092KU4JH) BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MICA (UNII: V8A1AW0880) BRAZILIAN PEPPER (UNII: SUG822G7CD) PROPYLPARABEN (UNII: Z8IX2SC1OH) CHOLESTEROL (UNII: 97C5T2UQ7J) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) DIMETHICONE (UNII: 92RU3N3Y1O) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) D&C RED NO. 27 (UNII: 2LRS185U6K) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) WATER (UNII: 059QF0KO0R) COCONUT OIL (UNII: Q9L0O73W7L) OLEYL ALCOHOL (UNII: 172F2WN8DV) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color RED, PINK (MAGENTA ENAMORADA) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-368-02 1 in 1 CARTON 1 NDC:13537-368-01 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/02/2011 ESIKA CORE SENSATIONS
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-369 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.065 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.020 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) CASTOR OIL (UNII: D5340Y2I9G) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) OCTYLDODECANOL (UNII: 461N1O614Y) CANDELILLA WAX (UNII: WL0328HX19) CARNAUBA WAX (UNII: R12CBM0EIZ) TRIDECYL STEARATE (UNII: A8OE252M6L) CETYL ALCOHOL (UNII: 936JST6JCN) MENTHYL LACTATE (UNII: 2BF9E65L7I) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82) SHEA BUTTER (UNII: K49155WL9Y) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PEPPERMINT OIL (UNII: AV092KU4JH) BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MICA (UNII: V8A1AW0880) BRAZILIAN PEPPER (UNII: SUG822G7CD) PROPYLPARABEN (UNII: Z8IX2SC1OH) CHOLESTEROL (UNII: 97C5T2UQ7J) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) DIMETHICONE (UNII: 92RU3N3Y1O) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) D&C RED NO. 27 (UNII: 2LRS185U6K) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) WATER (UNII: 059QF0KO0R) COCONUT OIL (UNII: Q9L0O73W7L) OLEYL ALCOHOL (UNII: 172F2WN8DV) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color RED (ROSA TERNURA) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-369-02 1 in 1 CARTON 1 NDC:13537-369-01 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/02/2011 ESIKA CORE SENSATIONS
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-370 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.065 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.020 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) CASTOR OIL (UNII: D5340Y2I9G) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) OCTYLDODECANOL (UNII: 461N1O614Y) CANDELILLA WAX (UNII: WL0328HX19) CARNAUBA WAX (UNII: R12CBM0EIZ) TRIDECYL STEARATE (UNII: A8OE252M6L) CETYL ALCOHOL (UNII: 936JST6JCN) MENTHYL LACTATE (UNII: 2BF9E65L7I) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82) SHEA BUTTER (UNII: K49155WL9Y) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PEPPERMINT OIL (UNII: AV092KU4JH) BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MICA (UNII: V8A1AW0880) BRAZILIAN PEPPER (UNII: SUG822G7CD) PROPYLPARABEN (UNII: Z8IX2SC1OH) CHOLESTEROL (UNII: 97C5T2UQ7J) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) DIMETHICONE (UNII: 92RU3N3Y1O) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) D&C RED NO. 27 (UNII: 2LRS185U6K) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) WATER (UNII: 059QF0KO0R) COCONUT OIL (UNII: Q9L0O73W7L) OLEYL ALCOHOL (UNII: 172F2WN8DV) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color RED, PINK (MALVA ROMÁNTICA) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-370-02 1 in 1 CARTON 1 NDC:13537-370-01 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/02/2011 ESIKA CORE SENSATIONS
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-371 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.065 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.020 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) CASTOR OIL (UNII: D5340Y2I9G) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) OCTYLDODECANOL (UNII: 461N1O614Y) CANDELILLA WAX (UNII: WL0328HX19) CARNAUBA WAX (UNII: R12CBM0EIZ) TRIDECYL STEARATE (UNII: A8OE252M6L) CETYL ALCOHOL (UNII: 936JST6JCN) MENTHYL LACTATE (UNII: 2BF9E65L7I) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82) SHEA BUTTER (UNII: K49155WL9Y) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PEPPERMINT OIL (UNII: AV092KU4JH) BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MICA (UNII: V8A1AW0880) BRAZILIAN PEPPER (UNII: SUG822G7CD) PROPYLPARABEN (UNII: Z8IX2SC1OH) CHOLESTEROL (UNII: 97C5T2UQ7J) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) DIMETHICONE (UNII: 92RU3N3Y1O) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) D&C RED NO. 27 (UNII: 2LRS185U6K) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) WATER (UNII: 059QF0KO0R) COCONUT OIL (UNII: Q9L0O73W7L) OLEYL ALCOHOL (UNII: 172F2WN8DV) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color RED (VINO SEDUCTOR) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-371-02 1 in 1 CARTON 1 NDC:13537-371-01 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/02/2011 ESIKA CORE SENSATIONS
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-372 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.065 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.020 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) CASTOR OIL (UNII: D5340Y2I9G) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) OCTYLDODECANOL (UNII: 461N1O614Y) CANDELILLA WAX (UNII: WL0328HX19) CARNAUBA WAX (UNII: R12CBM0EIZ) TRIDECYL STEARATE (UNII: A8OE252M6L) CETYL ALCOHOL (UNII: 936JST6JCN) MENTHYL LACTATE (UNII: 2BF9E65L7I) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82) SHEA BUTTER (UNII: K49155WL9Y) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PEPPERMINT OIL (UNII: AV092KU4JH) BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MICA (UNII: V8A1AW0880) BRAZILIAN PEPPER (UNII: SUG822G7CD) PROPYLPARABEN (UNII: Z8IX2SC1OH) CHOLESTEROL (UNII: 97C5T2UQ7J) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) DIMETHICONE (UNII: 92RU3N3Y1O) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) D&C RED NO. 27 (UNII: 2LRS185U6K) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) WATER (UNII: 059QF0KO0R) COCONUT OIL (UNII: Q9L0O73W7L) OLEYL ALCOHOL (UNII: 172F2WN8DV) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color BROWN (BRONCE CAUTIVANTE) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-372-02 1 in 1 CARTON 1 NDC:13537-372-01 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/02/2011 ESIKA CORE SENSATIONS
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-373 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.065 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.020 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) CASTOR OIL (UNII: D5340Y2I9G) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) OCTYLDODECANOL (UNII: 461N1O614Y) CANDELILLA WAX (UNII: WL0328HX19) CARNAUBA WAX (UNII: R12CBM0EIZ) TRIDECYL STEARATE (UNII: A8OE252M6L) CETYL ALCOHOL (UNII: 936JST6JCN) MENTHYL LACTATE (UNII: 2BF9E65L7I) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82) SHEA BUTTER (UNII: K49155WL9Y) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PEPPERMINT OIL (UNII: AV092KU4JH) BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MICA (UNII: V8A1AW0880) BRAZILIAN PEPPER (UNII: SUG822G7CD) PROPYLPARABEN (UNII: Z8IX2SC1OH) CHOLESTEROL (UNII: 97C5T2UQ7J) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) DIMETHICONE (UNII: 92RU3N3Y1O) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) D&C RED NO. 27 (UNII: 2LRS185U6K) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) WATER (UNII: 059QF0KO0R) COCONUT OIL (UNII: Q9L0O73W7L) OLEYL ALCOHOL (UNII: 172F2WN8DV) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color RED (FUCSIA FESTIVA) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-373-02 1 in 1 CARTON 1 NDC:13537-373-01 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/02/2011 ESIKA CORE SENSATIONS
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-374 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.065 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.020 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) CASTOR OIL (UNII: D5340Y2I9G) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) OCTYLDODECANOL (UNII: 461N1O614Y) CANDELILLA WAX (UNII: WL0328HX19) CARNAUBA WAX (UNII: R12CBM0EIZ) TRIDECYL STEARATE (UNII: A8OE252M6L) CETYL ALCOHOL (UNII: 936JST6JCN) MENTHYL LACTATE (UNII: 2BF9E65L7I) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82) SHEA BUTTER (UNII: K49155WL9Y) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PEPPERMINT OIL (UNII: AV092KU4JH) BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MICA (UNII: V8A1AW0880) BRAZILIAN PEPPER (UNII: SUG822G7CD) PROPYLPARABEN (UNII: Z8IX2SC1OH) CHOLESTEROL (UNII: 97C5T2UQ7J) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) DIMETHICONE (UNII: 92RU3N3Y1O) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) D&C RED NO. 27 (UNII: 2LRS185U6K) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) WATER (UNII: 059QF0KO0R) COCONUT OIL (UNII: Q9L0O73W7L) OLEYL ALCOHOL (UNII: 172F2WN8DV) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color ORANGE (CORAL ENCANTADOR) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-374-02 1 in 1 CARTON 1 NDC:13537-374-01 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/02/2011 Labeler - Ventura Corporation (San Juan, P.R) (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE Establishment Name Address ID/FEI Business Operations Yobel Supply Chain Management, S. A. 934116930 MANUFACTURE
