Label: ESIKA- octinoxate and oxybenzone lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-343-01, 13537-343-02, 13537-344-01, 13537-344-02, view more13537-345-01, 13537-345-02, 13537-346-01, 13537-346-02, 13537-347-01, 13537-347-02, 13537-348-01, 13537-348-02, 13537-349-01, 13537-349-02, 13537-350-01, 13537-350-02, 13537-351-01, 13537-351-02, 13537-352-01, 13537-352-02 - Packager: Ventura Corporation (San Juan, P.R)
- Category: HUMAN OTC DRUG LABEL
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 May 18, 2011
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- Official Label (Printer Friendly)
- Active Ingredients
- Use
- Warnings
- Directions
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Inactive Ingredients
Diisopropyl dimer dilinoleate, ethylhexyl palmitate, ozokerite, copernicia cerifera cera (copernicia cerifera (carnauba ) wax), polyethylene, butyrospermum parkii butter (butyrospermum parkii (shea) butter), silica, octyldodecanol, aqua (water), phenoxyethanol, microcristallina cera (microcrystalline wax), petrolatum, phospholipids, methylparaben, parfum (fragrance), bht, cholesterol, butylparaben, ethylparaben, candelilla cera (euphorbia cerifera (candelilla) wax), cera alba (beeswax), cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, isobutylparaben, propylparaben, glycosphingolipids, maltodextrin, zea mays starch( zea mays (corn) starch), sodium hyaluronate, CI 15850 (red 7 lake), CI 45410 (red 27 lake), CI 77491 (iron oxides), CI 77492 (iron oxides), CI 77499 (iron oxides), CI 77019 (mica), CI 19140 (yellow 5 lake), CI 77891 (titanium dioxide ), CI 15850 (red 6 lake), isononyl isononanoate, talc, isopropyl myristate, CI 42090 (blue 1 lake), CI 75470 (carmine), isopropyl titanium triisostearate, triethoxycaprylylsilane, stearalkonium hectorite, C9-15 fluoroalcohol phosphate, polyhydroxystearic acid, propylene carbonate.
- PRINCIPAL DISPLAY PANEL - 4 g Carton - Rojo Amor
- PRINCIPAL DISPLAY PANEL - 4 g Carton - Naranja Vivaz
- PRINCIPAL DISPLAY PANEL - 4 g Carton - Rojo Cherry
- PRINCIPAL DISPLAY PANEL - 4 g Carton - Fucsia Fancy
- PRINCIPAL DISPLAY PANEL - 4 g Carton - Magenta Atrevida
- PRINCIPAL DISPLAY PANEL - 4 g Carton - Vino Glamour
- PRINCIPAL DISPLAY PANEL - 4 g Carton - Rosa Divina
- PRINCIPAL DISPLAY PANEL - 4 g Carton - Coral Shine
- PRINCIPAL DISPLAY PANEL - 4 g Carton - Mocca Misterio
- PRINCIPAL DISPLAY PANEL - 4 g Carton - Marron Calido
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INGREDIENTS AND APPEARANCE
ESIKA MAXIMUM COLOR SPF 18
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-343 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.073 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.0165 g in 1 g Inactive Ingredients Ingredient Name Strength ethylhexyl palmitate (UNII: 2865993309) carnauba wax (UNII: R12CBM0EIZ) shea butter (UNII: K49155WL9Y) silicon dioxide (UNII: ETJ7Z6XBU4) octyldodecanol (UNII: 461N1O614Y) water (UNII: 059QF0KO0R) phenoxyethanol (UNII: HIE492ZZ3T) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) methylparaben (UNII: A2I8C7HI9T) butylated hydroxytoluene (UNII: 1P9D0Z171K) cholesterol (UNII: 97C5T2UQ7J) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) isobutylparaben (UNII: 0QQJ25X58G) propylparaben (UNII: Z8IX2SC1OH) maltodextrin (UNII: 7CVR7L4A2D) starch, corn (UNII: O8232NY3SJ) hyaluronate sodium (UNII: YSE9PPT4TH) d&c red no. 7 (UNII: ECW0LZ41X8) d&c red no. 28 (UNII: 767IP0Y5NH) aluminum oxide (UNII: LMI26O6933) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) mica (UNII: V8A1AW0880) fd&c yellow no. 5 (UNII: I753WB2F1M) titanium dioxide (UNII: 15FIX9V2JP) d&c red no. 6 (UNII: 481744AI4O) isononyl isononanoate (UNII: S4V5BS6GCX) talc (UNII: 7SEV7J4R1U) isopropyl myristate (UNII: 0RE8K4LNJS) fd&c blue no. 1 (UNII: H3R47K3TBD) cochineal (UNII: TZ8Z31B35M) triethoxycaprylylsilane (UNII: LDC331P08E) propylene carbonate (UNII: 8D08K3S51E) Product Characteristics Color RED (Rojo Amor) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-343-02 1 in 1 BOX 1 NDC:13537-343-01 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 05/17/2011 ESIKA MAXIMUM COLOR SPF 18
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-344 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.073 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.0165 g in 1 g Inactive Ingredients Ingredient Name Strength ethylhexyl palmitate (UNII: 2865993309) carnauba wax (UNII: R12CBM0EIZ) shea butter (UNII: K49155WL9Y) silicon dioxide (UNII: ETJ7Z6XBU4) octyldodecanol (UNII: 461N1O614Y) water (UNII: 059QF0KO0R) phenoxyethanol (UNII: HIE492ZZ3T) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) methylparaben (UNII: A2I8C7HI9T) butylated hydroxytoluene (UNII: 1P9D0Z171K) cholesterol (UNII: 97C5T2UQ7J) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) isobutylparaben (UNII: 0QQJ25X58G) propylparaben (UNII: Z8IX2SC1OH) maltodextrin (UNII: 7CVR7L4A2D) starch, corn (UNII: O8232NY3SJ) hyaluronate sodium (UNII: YSE9PPT4TH) d&c red no. 7 (UNII: ECW0LZ41X8) d&c red no. 28 (UNII: 767IP0Y5NH) aluminum oxide (UNII: LMI26O6933) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) mica (UNII: V8A1AW0880) fd&c yellow no. 5 (UNII: I753WB2F1M) titanium dioxide (UNII: 15FIX9V2JP) d&c red no. 6 (UNII: 481744AI4O) isononyl isononanoate (UNII: S4V5BS6GCX) talc (UNII: 7SEV7J4R1U) isopropyl myristate (UNII: 0RE8K4LNJS) fd&c blue no. 1 (UNII: H3R47K3TBD) cochineal (UNII: TZ8Z31B35M) triethoxycaprylylsilane (UNII: LDC331P08E) propylene carbonate (UNII: 8D08K3S51E) Product Characteristics Color ORANGE (Naranja Vivaz) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-344-02 1 in 1 BOX 1 NDC:13537-344-01 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 05/17/2011 ESIKA MAXIMUM COLOR SPF 18
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-345 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.073 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.0165 g in 1 g Inactive Ingredients Ingredient Name Strength ethylhexyl palmitate (UNII: 2865993309) carnauba wax (UNII: R12CBM0EIZ) shea butter (UNII: K49155WL9Y) silicon dioxide (UNII: ETJ7Z6XBU4) octyldodecanol (UNII: 461N1O614Y) water (UNII: 059QF0KO0R) phenoxyethanol (UNII: HIE492ZZ3T) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) methylparaben (UNII: A2I8C7HI9T) butylated hydroxytoluene (UNII: 1P9D0Z171K) cholesterol (UNII: 97C5T2UQ7J) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) isobutylparaben (UNII: 0QQJ25X58G) propylparaben (UNII: Z8IX2SC1OH) maltodextrin (UNII: 7CVR7L4A2D) starch, corn (UNII: O8232NY3SJ) hyaluronate sodium (UNII: YSE9PPT4TH) d&c red no. 7 (UNII: ECW0LZ41X8) d&c red no. 28 (UNII: 767IP0Y5NH) aluminum oxide (UNII: LMI26O6933) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) mica (UNII: V8A1AW0880) fd&c yellow no. 5 (UNII: I753WB2F1M) titanium dioxide (UNII: 15FIX9V2JP) d&c red no. 6 (UNII: 481744AI4O) isononyl isononanoate (UNII: S4V5BS6GCX) talc (UNII: 7SEV7J4R1U) isopropyl myristate (UNII: 0RE8K4LNJS) fd&c blue no. 1 (UNII: H3R47K3TBD) cochineal (UNII: TZ8Z31B35M) triethoxycaprylylsilane (UNII: LDC331P08E) propylene carbonate (UNII: 8D08K3S51E) Product Characteristics Color RED (Rojo Cherry) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-345-02 1 in 1 BOX 1 NDC:13537-345-01 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 05/17/2011 ESIKA MAXIMUM COLOR SPF 18
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-346 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.073 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.0165 g in 1 g Inactive Ingredients Ingredient Name Strength ethylhexyl palmitate (UNII: 2865993309) carnauba wax (UNII: R12CBM0EIZ) shea butter (UNII: K49155WL9Y) silicon dioxide (UNII: ETJ7Z6XBU4) octyldodecanol (UNII: 461N1O614Y) water (UNII: 059QF0KO0R) phenoxyethanol (UNII: HIE492ZZ3T) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) methylparaben (UNII: A2I8C7HI9T) butylated hydroxytoluene (UNII: 1P9D0Z171K) cholesterol (UNII: 97C5T2UQ7J) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) isobutylparaben (UNII: 0QQJ25X58G) propylparaben (UNII: Z8IX2SC1OH) maltodextrin (UNII: 7CVR7L4A2D) starch, corn (UNII: O8232NY3SJ) hyaluronate sodium (UNII: YSE9PPT4TH) d&c red no. 7 (UNII: ECW0LZ41X8) d&c red no. 28 (UNII: 767IP0Y5NH) aluminum oxide (UNII: LMI26O6933) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) mica (UNII: V8A1AW0880) fd&c yellow no. 5 (UNII: I753WB2F1M) titanium dioxide (UNII: 15FIX9V2JP) d&c red no. 6 (UNII: 481744AI4O) isononyl isononanoate (UNII: S4V5BS6GCX) talc (UNII: 7SEV7J4R1U) isopropyl myristate (UNII: 0RE8K4LNJS) fd&c blue no. 1 (UNII: H3R47K3TBD) cochineal (UNII: TZ8Z31B35M) triethoxycaprylylsilane (UNII: LDC331P08E) propylene carbonate (UNII: 8D08K3S51E) Product Characteristics Color PINK (Fucsia Fancy) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-346-02 1 in 1 BOX 1 NDC:13537-346-01 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 05/17/2011 ESIKA MAXIMUM COLOR SPF 18
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-347 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.073 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.0165 g in 1 g Inactive Ingredients Ingredient Name Strength ethylhexyl palmitate (UNII: 2865993309) carnauba wax (UNII: R12CBM0EIZ) shea butter (UNII: K49155WL9Y) silicon dioxide (UNII: ETJ7Z6XBU4) octyldodecanol (UNII: 461N1O614Y) water (UNII: 059QF0KO0R) phenoxyethanol (UNII: HIE492ZZ3T) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) methylparaben (UNII: A2I8C7HI9T) butylated hydroxytoluene (UNII: 1P9D0Z171K) cholesterol (UNII: 97C5T2UQ7J) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) isobutylparaben (UNII: 0QQJ25X58G) propylparaben (UNII: Z8IX2SC1OH) maltodextrin (UNII: 7CVR7L4A2D) starch, corn (UNII: O8232NY3SJ) hyaluronate sodium (UNII: YSE9PPT4TH) d&c red no. 7 (UNII: ECW0LZ41X8) d&c red no. 28 (UNII: 767IP0Y5NH) aluminum oxide (UNII: LMI26O6933) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) mica (UNII: V8A1AW0880) fd&c yellow no. 5 (UNII: I753WB2F1M) titanium dioxide (UNII: 15FIX9V2JP) d&c red no. 6 (UNII: 481744AI4O) isononyl isononanoate (UNII: S4V5BS6GCX) talc (UNII: 7SEV7J4R1U) isopropyl myristate (UNII: 0RE8K4LNJS) fd&c blue no. 1 (UNII: H3R47K3TBD) cochineal (UNII: TZ8Z31B35M) triethoxycaprylylsilane (UNII: LDC331P08E) propylene carbonate (UNII: 8D08K3S51E) Product Characteristics Color PURPLE (Magenta Atrevida) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-347-02 1 in 1 BOX 1 NDC:13537-347-01 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 05/17/2011 ESIKA MAXIMUM COLOR SPF 18
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-348 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.073 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.0165 g in 1 g Inactive Ingredients Ingredient Name Strength ethylhexyl palmitate (UNII: 2865993309) carnauba wax (UNII: R12CBM0EIZ) shea butter (UNII: K49155WL9Y) silicon dioxide (UNII: ETJ7Z6XBU4) octyldodecanol (UNII: 461N1O614Y) water (UNII: 059QF0KO0R) phenoxyethanol (UNII: HIE492ZZ3T) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) methylparaben (UNII: A2I8C7HI9T) butylated hydroxytoluene (UNII: 1P9D0Z171K) cholesterol (UNII: 97C5T2UQ7J) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) isobutylparaben (UNII: 0QQJ25X58G) propylparaben (UNII: Z8IX2SC1OH) maltodextrin (UNII: 7CVR7L4A2D) starch, corn (UNII: O8232NY3SJ) hyaluronate sodium (UNII: YSE9PPT4TH) d&c red no. 7 (UNII: ECW0LZ41X8) d&c red no. 28 (UNII: 767IP0Y5NH) aluminum oxide (UNII: LMI26O6933) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) mica (UNII: V8A1AW0880) fd&c yellow no. 5 (UNII: I753WB2F1M) titanium dioxide (UNII: 15FIX9V2JP) d&c red no. 6 (UNII: 481744AI4O) isononyl isononanoate (UNII: S4V5BS6GCX) talc (UNII: 7SEV7J4R1U) isopropyl myristate (UNII: 0RE8K4LNJS) fd&c blue no. 1 (UNII: H3R47K3TBD) cochineal (UNII: TZ8Z31B35M) triethoxycaprylylsilane (UNII: LDC331P08E) propylene carbonate (UNII: 8D08K3S51E) Product Characteristics Color RED (Vino Glamour) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-348-02 1 in 1 BOX 1 NDC:13537-348-01 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 05/17/2011 ESIKA MAXIMUM COLOR SPF 18
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-349 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.073 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.0165 g in 1 g Inactive Ingredients Ingredient Name Strength ethylhexyl palmitate (UNII: 2865993309) carnauba wax (UNII: R12CBM0EIZ) shea butter (UNII: K49155WL9Y) silicon dioxide (UNII: ETJ7Z6XBU4) octyldodecanol (UNII: 461N1O614Y) water (UNII: 059QF0KO0R) phenoxyethanol (UNII: HIE492ZZ3T) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) methylparaben (UNII: A2I8C7HI9T) butylated hydroxytoluene (UNII: 1P9D0Z171K) cholesterol (UNII: 97C5T2UQ7J) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) isobutylparaben (UNII: 0QQJ25X58G) propylparaben (UNII: Z8IX2SC1OH) maltodextrin (UNII: 7CVR7L4A2D) starch, corn (UNII: O8232NY3SJ) hyaluronate sodium (UNII: YSE9PPT4TH) d&c red no. 7 (UNII: ECW0LZ41X8) d&c red no. 28 (UNII: 767IP0Y5NH) aluminum oxide (UNII: LMI26O6933) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) mica (UNII: V8A1AW0880) fd&c yellow no. 5 (UNII: I753WB2F1M) titanium dioxide (UNII: 15FIX9V2JP) d&c red no. 6 (UNII: 481744AI4O) isononyl isononanoate (UNII: S4V5BS6GCX) talc (UNII: 7SEV7J4R1U) isopropyl myristate (UNII: 0RE8K4LNJS) fd&c blue no. 1 (UNII: H3R47K3TBD) cochineal (UNII: TZ8Z31B35M) triethoxycaprylylsilane (UNII: LDC331P08E) propylene carbonate (UNII: 8D08K3S51E) Product Characteristics Color RED (Rosa Divina) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-349-02 1 in 1 BOX 1 NDC:13537-349-01 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 05/17/2011 ESIKA MAXIMUM COLOR SPF 18
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-350 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.073 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.0165 g in 1 g Inactive Ingredients Ingredient Name Strength ethylhexyl palmitate (UNII: 2865993309) carnauba wax (UNII: R12CBM0EIZ) shea butter (UNII: K49155WL9Y) silicon dioxide (UNII: ETJ7Z6XBU4) octyldodecanol (UNII: 461N1O614Y) water (UNII: 059QF0KO0R) phenoxyethanol (UNII: HIE492ZZ3T) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) methylparaben (UNII: A2I8C7HI9T) butylated hydroxytoluene (UNII: 1P9D0Z171K) cholesterol (UNII: 97C5T2UQ7J) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) isobutylparaben (UNII: 0QQJ25X58G) propylparaben (UNII: Z8IX2SC1OH) maltodextrin (UNII: 7CVR7L4A2D) starch, corn (UNII: O8232NY3SJ) hyaluronate sodium (UNII: YSE9PPT4TH) d&c red no. 7 (UNII: ECW0LZ41X8) d&c red no. 28 (UNII: 767IP0Y5NH) aluminum oxide (UNII: LMI26O6933) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) mica (UNII: V8A1AW0880) fd&c yellow no. 5 (UNII: I753WB2F1M) titanium dioxide (UNII: 15FIX9V2JP) d&c red no. 6 (UNII: 481744AI4O) isononyl isononanoate (UNII: S4V5BS6GCX) talc (UNII: 7SEV7J4R1U) isopropyl myristate (UNII: 0RE8K4LNJS) fd&c blue no. 1 (UNII: H3R47K3TBD) cochineal (UNII: TZ8Z31B35M) triethoxycaprylylsilane (UNII: LDC331P08E) propylene carbonate (UNII: 8D08K3S51E) Product Characteristics Color RED (Coral Shine) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-350-02 1 in 1 BOX 1 NDC:13537-350-01 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 05/17/2011 ESIKA MAXIMUM COLOR SPF 18
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-351 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.073 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.0165 g in 1 g Inactive Ingredients Ingredient Name Strength ethylhexyl palmitate (UNII: 2865993309) carnauba wax (UNII: R12CBM0EIZ) shea butter (UNII: K49155WL9Y) silicon dioxide (UNII: ETJ7Z6XBU4) octyldodecanol (UNII: 461N1O614Y) water (UNII: 059QF0KO0R) phenoxyethanol (UNII: HIE492ZZ3T) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) methylparaben (UNII: A2I8C7HI9T) butylated hydroxytoluene (UNII: 1P9D0Z171K) cholesterol (UNII: 97C5T2UQ7J) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) isobutylparaben (UNII: 0QQJ25X58G) propylparaben (UNII: Z8IX2SC1OH) maltodextrin (UNII: 7CVR7L4A2D) starch, corn (UNII: O8232NY3SJ) hyaluronate sodium (UNII: YSE9PPT4TH) d&c red no. 7 (UNII: ECW0LZ41X8) d&c red no. 28 (UNII: 767IP0Y5NH) aluminum oxide (UNII: LMI26O6933) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) mica (UNII: V8A1AW0880) fd&c yellow no. 5 (UNII: I753WB2F1M) titanium dioxide (UNII: 15FIX9V2JP) d&c red no. 6 (UNII: 481744AI4O) isononyl isononanoate (UNII: S4V5BS6GCX) talc (UNII: 7SEV7J4R1U) isopropyl myristate (UNII: 0RE8K4LNJS) fd&c blue no. 1 (UNII: H3R47K3TBD) cochineal (UNII: TZ8Z31B35M) triethoxycaprylylsilane (UNII: LDC331P08E) propylene carbonate (UNII: 8D08K3S51E) Product Characteristics Color BROWN (Mocca Misterio) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-351-02 1 in 1 BOX 1 NDC:13537-351-01 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 05/17/2011 ESIKA MAXIMUM COLOR SPF 18
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-352 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.073 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.0165 g in 1 g Inactive Ingredients Ingredient Name Strength ethylhexyl palmitate (UNII: 2865993309) carnauba wax (UNII: R12CBM0EIZ) shea butter (UNII: K49155WL9Y) silicon dioxide (UNII: ETJ7Z6XBU4) octyldodecanol (UNII: 461N1O614Y) water (UNII: 059QF0KO0R) phenoxyethanol (UNII: HIE492ZZ3T) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) methylparaben (UNII: A2I8C7HI9T) butylated hydroxytoluene (UNII: 1P9D0Z171K) cholesterol (UNII: 97C5T2UQ7J) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) isobutylparaben (UNII: 0QQJ25X58G) propylparaben (UNII: Z8IX2SC1OH) maltodextrin (UNII: 7CVR7L4A2D) starch, corn (UNII: O8232NY3SJ) hyaluronate sodium (UNII: YSE9PPT4TH) d&c red no. 7 (UNII: ECW0LZ41X8) d&c red no. 28 (UNII: 767IP0Y5NH) aluminum oxide (UNII: LMI26O6933) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) mica (UNII: V8A1AW0880) fd&c yellow no. 5 (UNII: I753WB2F1M) titanium dioxide (UNII: 15FIX9V2JP) d&c red no. 6 (UNII: 481744AI4O) isononyl isononanoate (UNII: S4V5BS6GCX) talc (UNII: 7SEV7J4R1U) isopropyl myristate (UNII: 0RE8K4LNJS) fd&c blue no. 1 (UNII: H3R47K3TBD) cochineal (UNII: TZ8Z31B35M) triethoxycaprylylsilane (UNII: LDC331P08E) propylene carbonate (UNII: 8D08K3S51E) Product Characteristics Color BROWN (Marron Calido) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-352-02 1 in 1 BOX 1 NDC:13537-352-01 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 05/17/2011 Labeler - Ventura Corporation (San Juan, P.R) (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE
