Label: ESIKA- octinoxate and oxybenzone lipstick
- Label RSS
- Share
-
Contains inactivated NDC Code(s)
NDC Code(s): 13537-049-01, 13537-049-02, 13537-050-01, 13537-050-02, view more13537-051-01, 13537-051-02, 13537-052-01, 13537-052-02, 13537-053-01, 13537-053-02, 13537-054-01, 13537-054-02, 13537-055-01, 13537-055-02, 13537-056-01, 13537-056-02, 13537-057-01, 13537-057-02, 13537-058-01, 13537-058-02, 13537-059-01, 13537-059-02, 13537-060-01, 13537-060-02 - 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 September 20, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Use
- Warnings
- Directions
-
Inactive Ingredients
Ricinus communis seed oil (ricinus communis (castor) seed oil), ethylhexyl palmitate, caprylic/capric triglyceride, polyethylene, candelilla cera (euphorbia cerifera (candelilla) wax), butyrospermum parkii (butyrospermum parkii (shea butter)), cera alba (beeswax), silica dimethyl silylate, glycerin, octyldodecanol, parfum (fragrance), glyceryl isostearate, isostearyl alcohol, sodium saccharin, propylparaben, cera microcristallina (microcrystalline wax), beta-sitosterol, petrolatum, bht, phospholipids, cholesterol, cetearyl alcohol, cetearyl glucoside, copernicia cerifera cera (copernicia cerifera (carnauba ) wax), polyglyceryl-2 dipolyhydroxystearate, glycosphingolipids, CI 77742 (manganese violet), CI 77491 (iron oxides), CI 77499 (iron oxides), CI 77492 (iron oxides), CI 77891 (titanium dioxide ), CI 45410 (red 27 lake), CI 15850 (red 7 lake), CI 45380 (red 21 lake), CI 19140 (yellow 5 lake), CI 77019 (mica), CI 73360 (red 30 lake), talc, CI 42090 (blue 1 lake), CI 75470 (carmine)
- PRINCIPAL DISPLAY PANEL - 4 g Carton - ROJO PROVOCACION
- PRINCIPAL DISPLAY PANEL - 4 g Carton - ROJO VIVAZ
- PRINCIPAL DISPLAY PANEL - 4 g Carton - FUCSIA FANTASIA
- PRINCIPAL DISPLAY PANEL - 4 g Carton - FUCSIA SEDUCTOR
- PRINCIPAL DISPLAY PANEL - 4 g Carton - ROSA INTRIGA
- PRINCIPAL DISPLAY PANEL - 4 g Carton - MORADO OBSESION
- PRINCIPAL DISPLAY PANEL - 4 g Carton - ROSA COQUETA
- PRINCIPAL DISPLAY PANEL - 4 g Carton - MALVA ILUSION
- PRINCIPAL DISPLAY PANEL - 4 g Carton - VINO SENSUAL
- PRINCIPAL DISPLAY PANEL - 4 g Carton - MARRON OTONO
- PRINCIPAL DISPLAY PANEL - 4 g Carton - MARRON TENTACION
- PRINCIPAL DISPLAY PANEL - 4 g Carton - ROSADO MAGICO
-
INGREDIENTS AND APPEARANCE
ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-049 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 0.0182 g in 1 g Inactive Ingredients Ingredient Name Strength castor oil (UNII: D5340Y2I9G) ethylhexyl palmitate (UNII: 2865993309) medium-chain triglycerides (UNII: C9H2L21V7U) high density polyethylene (UNII: UG00KM4WR7) candelilla wax (UNII: WL0328HX19) shea butter (UNII: K49155WL9Y) yellow wax (UNII: 2ZA36H0S2V) glycerin (UNII: PDC6A3C0OX) octyldodecanol (UNII: 461N1O614Y) glyceryl isostearate (UNII: HYE7O27HAO) isostearyl alcohol (UNII: Q613OCQ44Y) saccharin sodium (UNII: SB8ZUX40TY) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) .beta.-sitosterol (UNII: S347WMO6M4) petrolatum (UNII: 4T6H12BN9U) butylated hydroxytoluene (UNII: 1P9D0Z171K) cholesterol (UNII: 97C5T2UQ7J) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) ferric oxide yellow (UNII: EX438O2MRT) titanium dioxide (UNII: 15FIX9V2JP) D&C red no. 27 (UNII: 2LRS185U6K) D&C red no. 7 (UNII: ECW0LZ41X8) D&C red no. 21 (UNII: 08744Z6JNY) FD&C yellow no. 5 (UNII: I753WB2F1M) D&C red no. 30 (UNII: 2S42T2808B) FD&C blue no. 1 (UNII: H3R47K3TBD) mica (UNII: V8A1AW0880) talc (UNII: 7SEV7J4R1U) cochineal (UNII: TZ8Z31B35M) Product Characteristics Color RED (ROJO PROVOCACION) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-049-02 1 in 1 BOX 1 NDC:13537-049-01 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 09/23/2011 ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-050 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 0.0182 g in 1 g Inactive Ingredients Ingredient Name Strength castor oil (UNII: D5340Y2I9G) ethylhexyl palmitate (UNII: 2865993309) medium-chain triglycerides (UNII: C9H2L21V7U) high density polyethylene (UNII: UG00KM4WR7) candelilla wax (UNII: WL0328HX19) shea butter (UNII: K49155WL9Y) yellow wax (UNII: 2ZA36H0S2V) glycerin (UNII: PDC6A3C0OX) octyldodecanol (UNII: 461N1O614Y) glyceryl isostearate (UNII: HYE7O27HAO) isostearyl alcohol (UNII: Q613OCQ44Y) saccharin sodium (UNII: SB8ZUX40TY) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) .beta.-sitosterol (UNII: S347WMO6M4) petrolatum (UNII: 4T6H12BN9U) butylated hydroxytoluene (UNII: 1P9D0Z171K) cholesterol (UNII: 97C5T2UQ7J) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) ferric oxide yellow (UNII: EX438O2MRT) titanium dioxide (UNII: 15FIX9V2JP) D&C red no. 27 (UNII: 2LRS185U6K) D&C red no. 7 (UNII: ECW0LZ41X8) D&C red no. 21 (UNII: 08744Z6JNY) FD&C yellow no. 5 (UNII: I753WB2F1M) D&C red no. 30 (UNII: 2S42T2808B) FD&C blue no. 1 (UNII: H3R47K3TBD) aluminum oxide (UNII: LMI26O6933) mica (UNII: V8A1AW0880) talc (UNII: 7SEV7J4R1U) cochineal (UNII: TZ8Z31B35M) Product Characteristics Color RED (ROJO VIVAZ) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-050-02 1 in 1 BOX 1 NDC:13537-050-01 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 09/23/2011 ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-051 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 0.0182 g in 1 g Inactive Ingredients Ingredient Name Strength castor oil (UNII: D5340Y2I9G) ethylhexyl palmitate (UNII: 2865993309) medium-chain triglycerides (UNII: C9H2L21V7U) high density polyethylene (UNII: UG00KM4WR7) candelilla wax (UNII: WL0328HX19) shea butter (UNII: K49155WL9Y) yellow wax (UNII: 2ZA36H0S2V) glycerin (UNII: PDC6A3C0OX) octyldodecanol (UNII: 461N1O614Y) glyceryl isostearate (UNII: HYE7O27HAO) isostearyl alcohol (UNII: Q613OCQ44Y) saccharin sodium (UNII: SB8ZUX40TY) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) .beta.-sitosterol (UNII: S347WMO6M4) petrolatum (UNII: 4T6H12BN9U) butylated hydroxytoluene (UNII: 1P9D0Z171K) cholesterol (UNII: 97C5T2UQ7J) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) ferric oxide yellow (UNII: EX438O2MRT) titanium dioxide (UNII: 15FIX9V2JP) D&C red no. 27 (UNII: 2LRS185U6K) D&C red no. 7 (UNII: ECW0LZ41X8) D&C red no. 21 (UNII: 08744Z6JNY) FD&C yellow no. 5 (UNII: I753WB2F1M) D&C red no. 30 (UNII: 2S42T2808B) FD&C blue no. 1 (UNII: H3R47K3TBD) aluminum oxide (UNII: LMI26O6933) mica (UNII: V8A1AW0880) talc (UNII: 7SEV7J4R1U) cochineal (UNII: TZ8Z31B35M) Product Characteristics Color PURPLE (FUCSIA FANTASIA) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-051-02 1 in 1 BOX 1 NDC:13537-051-01 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 09/23/2011 ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-052 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 0.0182 g in 1 g Inactive Ingredients Ingredient Name Strength castor oil (UNII: D5340Y2I9G) ethylhexyl palmitate (UNII: 2865993309) medium-chain triglycerides (UNII: C9H2L21V7U) high density polyethylene (UNII: UG00KM4WR7) candelilla wax (UNII: WL0328HX19) shea butter (UNII: K49155WL9Y) yellow wax (UNII: 2ZA36H0S2V) glycerin (UNII: PDC6A3C0OX) octyldodecanol (UNII: 461N1O614Y) glyceryl isostearate (UNII: HYE7O27HAO) isostearyl alcohol (UNII: Q613OCQ44Y) saccharin sodium (UNII: SB8ZUX40TY) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) .beta.-sitosterol (UNII: S347WMO6M4) petrolatum (UNII: 4T6H12BN9U) butylated hydroxytoluene (UNII: 1P9D0Z171K) cholesterol (UNII: 97C5T2UQ7J) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) ferric oxide yellow (UNII: EX438O2MRT) titanium dioxide (UNII: 15FIX9V2JP) D&C red no. 27 (UNII: 2LRS185U6K) D&C red no. 7 (UNII: ECW0LZ41X8) D&C red no. 21 (UNII: 08744Z6JNY) FD&C yellow no. 5 (UNII: I753WB2F1M) D&C red no. 30 (UNII: 2S42T2808B) FD&C blue no. 1 (UNII: H3R47K3TBD) aluminum oxide (UNII: LMI26O6933) mica (UNII: V8A1AW0880) talc (UNII: 7SEV7J4R1U) cochineal (UNII: TZ8Z31B35M) Product Characteristics Color PURPLE (FUCSIA SEDUCTOR) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-052-02 1 in 1 BOX 1 NDC:13537-052-01 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 09/23/2011 ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-053 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 0.0182 g in 1 g Inactive Ingredients Ingredient Name Strength castor oil (UNII: D5340Y2I9G) ethylhexyl palmitate (UNII: 2865993309) medium-chain triglycerides (UNII: C9H2L21V7U) high density polyethylene (UNII: UG00KM4WR7) candelilla wax (UNII: WL0328HX19) shea butter (UNII: K49155WL9Y) yellow wax (UNII: 2ZA36H0S2V) glycerin (UNII: PDC6A3C0OX) octyldodecanol (UNII: 461N1O614Y) glyceryl isostearate (UNII: HYE7O27HAO) isostearyl alcohol (UNII: Q613OCQ44Y) saccharin sodium (UNII: SB8ZUX40TY) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) .beta.-sitosterol (UNII: S347WMO6M4) petrolatum (UNII: 4T6H12BN9U) butylated hydroxytoluene (UNII: 1P9D0Z171K) cholesterol (UNII: 97C5T2UQ7J) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) ferric oxide yellow (UNII: EX438O2MRT) titanium dioxide (UNII: 15FIX9V2JP) D&C red no. 27 (UNII: 2LRS185U6K) D&C red no. 7 (UNII: ECW0LZ41X8) D&C red no. 21 (UNII: 08744Z6JNY) FD&C yellow no. 5 (UNII: I753WB2F1M) D&C red no. 30 (UNII: 2S42T2808B) FD&C blue no. 1 (UNII: H3R47K3TBD) aluminum oxide (UNII: LMI26O6933) mica (UNII: V8A1AW0880) talc (UNII: 7SEV7J4R1U) cochineal (UNII: TZ8Z31B35M) Product Characteristics Color RED (ROSA INTRIGA) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-053-02 1 in 1 BOX 1 NDC:13537-053-01 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 09/23/2011 ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-054 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 0.0182 g in 1 g Inactive Ingredients Ingredient Name Strength castor oil (UNII: D5340Y2I9G) ethylhexyl palmitate (UNII: 2865993309) medium-chain triglycerides (UNII: C9H2L21V7U) high density polyethylene (UNII: UG00KM4WR7) candelilla wax (UNII: WL0328HX19) shea butter (UNII: K49155WL9Y) yellow wax (UNII: 2ZA36H0S2V) glycerin (UNII: PDC6A3C0OX) octyldodecanol (UNII: 461N1O614Y) glyceryl isostearate (UNII: HYE7O27HAO) isostearyl alcohol (UNII: Q613OCQ44Y) saccharin sodium (UNII: SB8ZUX40TY) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) .beta.-sitosterol (UNII: S347WMO6M4) petrolatum (UNII: 4T6H12BN9U) butylated hydroxytoluene (UNII: 1P9D0Z171K) cholesterol (UNII: 97C5T2UQ7J) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) ferric oxide yellow (UNII: EX438O2MRT) titanium dioxide (UNII: 15FIX9V2JP) D&C red no. 27 (UNII: 2LRS185U6K) D&C red no. 7 (UNII: ECW0LZ41X8) D&C red no. 21 (UNII: 08744Z6JNY) FD&C yellow no. 5 (UNII: I753WB2F1M) D&C red no. 30 (UNII: 2S42T2808B) FD&C blue no. 1 (UNII: H3R47K3TBD) aluminum oxide (UNII: LMI26O6933) mica (UNII: V8A1AW0880) talc (UNII: 7SEV7J4R1U) cochineal (UNII: TZ8Z31B35M) Product Characteristics Color BROWN (MORADO OBSESION) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-054-02 1 in 1 BOX 1 NDC:13537-054-01 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 09/23/2011 ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-055 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 0.0182 g in 1 g Inactive Ingredients Ingredient Name Strength castor oil (UNII: D5340Y2I9G) ethylhexyl palmitate (UNII: 2865993309) medium-chain triglycerides (UNII: C9H2L21V7U) high density polyethylene (UNII: UG00KM4WR7) candelilla wax (UNII: WL0328HX19) shea butter (UNII: K49155WL9Y) yellow wax (UNII: 2ZA36H0S2V) glycerin (UNII: PDC6A3C0OX) octyldodecanol (UNII: 461N1O614Y) glyceryl isostearate (UNII: HYE7O27HAO) isostearyl alcohol (UNII: Q613OCQ44Y) saccharin sodium (UNII: SB8ZUX40TY) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) .beta.-sitosterol (UNII: S347WMO6M4) petrolatum (UNII: 4T6H12BN9U) butylated hydroxytoluene (UNII: 1P9D0Z171K) cholesterol (UNII: 97C5T2UQ7J) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) ferric oxide yellow (UNII: EX438O2MRT) titanium dioxide (UNII: 15FIX9V2JP) D&C red no. 27 (UNII: 2LRS185U6K) D&C red no. 7 (UNII: ECW0LZ41X8) D&C red no. 21 (UNII: 08744Z6JNY) FD&C yellow no. 5 (UNII: I753WB2F1M) D&C red no. 30 (UNII: 2S42T2808B) FD&C blue no. 1 (UNII: H3R47K3TBD) aluminum oxide (UNII: LMI26O6933) mica (UNII: V8A1AW0880) talc (UNII: 7SEV7J4R1U) cochineal (UNII: TZ8Z31B35M) Product Characteristics Color RED (ROSA COQUETA) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-055-02 1 in 1 BOX 1 NDC:13537-055-01 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 09/23/2011 ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-056 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 0.0182 g in 1 g Inactive Ingredients Ingredient Name Strength castor oil (UNII: D5340Y2I9G) ethylhexyl palmitate (UNII: 2865993309) medium-chain triglycerides (UNII: C9H2L21V7U) high density polyethylene (UNII: UG00KM4WR7) candelilla wax (UNII: WL0328HX19) shea butter (UNII: K49155WL9Y) yellow wax (UNII: 2ZA36H0S2V) glycerin (UNII: PDC6A3C0OX) octyldodecanol (UNII: 461N1O614Y) glyceryl isostearate (UNII: HYE7O27HAO) isostearyl alcohol (UNII: Q613OCQ44Y) saccharin sodium (UNII: SB8ZUX40TY) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) .beta.-sitosterol (UNII: S347WMO6M4) petrolatum (UNII: 4T6H12BN9U) butylated hydroxytoluene (UNII: 1P9D0Z171K) cholesterol (UNII: 97C5T2UQ7J) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) ferric oxide yellow (UNII: EX438O2MRT) titanium dioxide (UNII: 15FIX9V2JP) D&C red no. 27 (UNII: 2LRS185U6K) D&C red no. 7 (UNII: ECW0LZ41X8) D&C red no. 21 (UNII: 08744Z6JNY) FD&C yellow no. 5 (UNII: I753WB2F1M) D&C red no. 30 (UNII: 2S42T2808B) FD&C blue no. 1 (UNII: H3R47K3TBD) aluminum oxide (UNII: LMI26O6933) mica (UNII: V8A1AW0880) talc (UNII: 7SEV7J4R1U) cochineal (UNII: TZ8Z31B35M) Product Characteristics Color PINK (MALVA ILUSION) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-056-02 1 in 1 BOX 1 NDC:13537-056-01 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 09/23/2011 ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-057 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 0.0182 g in 1 g Inactive Ingredients Ingredient Name Strength castor oil (UNII: D5340Y2I9G) ethylhexyl palmitate (UNII: 2865993309) medium-chain triglycerides (UNII: C9H2L21V7U) high density polyethylene (UNII: UG00KM4WR7) candelilla wax (UNII: WL0328HX19) shea butter (UNII: K49155WL9Y) yellow wax (UNII: 2ZA36H0S2V) glycerin (UNII: PDC6A3C0OX) octyldodecanol (UNII: 461N1O614Y) glyceryl isostearate (UNII: HYE7O27HAO) isostearyl alcohol (UNII: Q613OCQ44Y) saccharin sodium (UNII: SB8ZUX40TY) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) .beta.-sitosterol (UNII: S347WMO6M4) petrolatum (UNII: 4T6H12BN9U) butylated hydroxytoluene (UNII: 1P9D0Z171K) cholesterol (UNII: 97C5T2UQ7J) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) ferric oxide yellow (UNII: EX438O2MRT) titanium dioxide (UNII: 15FIX9V2JP) D&C red no. 27 (UNII: 2LRS185U6K) D&C red no. 7 (UNII: ECW0LZ41X8) D&C red no. 21 (UNII: 08744Z6JNY) FD&C yellow no. 5 (UNII: I753WB2F1M) D&C red no. 30 (UNII: 2S42T2808B) FD&C blue no. 1 (UNII: H3R47K3TBD) aluminum oxide (UNII: LMI26O6933) mica (UNII: V8A1AW0880) talc (UNII: 7SEV7J4R1U) cochineal (UNII: TZ8Z31B35M) Product Characteristics Color RED (VINO SENSUAL) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-057-02 1 in 1 BOX 1 NDC:13537-057-01 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 09/23/2011 ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-058 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 0.0182 g in 1 g Inactive Ingredients Ingredient Name Strength castor oil (UNII: D5340Y2I9G) ethylhexyl palmitate (UNII: 2865993309) medium-chain triglycerides (UNII: C9H2L21V7U) high density polyethylene (UNII: UG00KM4WR7) candelilla wax (UNII: WL0328HX19) shea butter (UNII: K49155WL9Y) yellow wax (UNII: 2ZA36H0S2V) glycerin (UNII: PDC6A3C0OX) octyldodecanol (UNII: 461N1O614Y) glyceryl isostearate (UNII: HYE7O27HAO) isostearyl alcohol (UNII: Q613OCQ44Y) saccharin sodium (UNII: SB8ZUX40TY) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) .beta.-sitosterol (UNII: S347WMO6M4) petrolatum (UNII: 4T6H12BN9U) butylated hydroxytoluene (UNII: 1P9D0Z171K) cholesterol (UNII: 97C5T2UQ7J) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) ferric oxide yellow (UNII: EX438O2MRT) titanium dioxide (UNII: 15FIX9V2JP) D&C red no. 27 (UNII: 2LRS185U6K) D&C red no. 7 (UNII: ECW0LZ41X8) D&C red no. 21 (UNII: 08744Z6JNY) FD&C yellow no. 5 (UNII: I753WB2F1M) D&C red no. 30 (UNII: 2S42T2808B) FD&C blue no. 1 (UNII: H3R47K3TBD) aluminum oxide (UNII: LMI26O6933) mica (UNII: V8A1AW0880) talc (UNII: 7SEV7J4R1U) cochineal (UNII: TZ8Z31B35M) Product Characteristics Color BROWN (MARRON OTONO) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-058-02 1 in 1 BOX 1 NDC:13537-058-01 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 09/23/2011 ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-059 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 0.0182 g in 1 g Inactive Ingredients Ingredient Name Strength castor oil (UNII: D5340Y2I9G) ethylhexyl palmitate (UNII: 2865993309) medium-chain triglycerides (UNII: C9H2L21V7U) high density polyethylene (UNII: UG00KM4WR7) candelilla wax (UNII: WL0328HX19) shea butter (UNII: K49155WL9Y) yellow wax (UNII: 2ZA36H0S2V) glycerin (UNII: PDC6A3C0OX) octyldodecanol (UNII: 461N1O614Y) glyceryl isostearate (UNII: HYE7O27HAO) isostearyl alcohol (UNII: Q613OCQ44Y) saccharin sodium (UNII: SB8ZUX40TY) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) .beta.-sitosterol (UNII: S347WMO6M4) petrolatum (UNII: 4T6H12BN9U) butylated hydroxytoluene (UNII: 1P9D0Z171K) cholesterol (UNII: 97C5T2UQ7J) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) ferric oxide yellow (UNII: EX438O2MRT) titanium dioxide (UNII: 15FIX9V2JP) D&C red no. 27 (UNII: 2LRS185U6K) D&C red no. 7 (UNII: ECW0LZ41X8) D&C red no. 21 (UNII: 08744Z6JNY) FD&C yellow no. 5 (UNII: I753WB2F1M) D&C red no. 30 (UNII: 2S42T2808B) FD&C blue no. 1 (UNII: H3R47K3TBD) aluminum oxide (UNII: LMI26O6933) mica (UNII: V8A1AW0880) talc (UNII: 7SEV7J4R1U) cochineal (UNII: TZ8Z31B35M) Product Characteristics Color BROWN (MARRON TENTACION) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-059-02 1 in 1 BOX 1 NDC:13537-059-01 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 09/23/2011 ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-060 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 0.0182 g in 1 g Inactive Ingredients Ingredient Name Strength castor oil (UNII: D5340Y2I9G) ethylhexyl palmitate (UNII: 2865993309) medium-chain triglycerides (UNII: C9H2L21V7U) high density polyethylene (UNII: UG00KM4WR7) candelilla wax (UNII: WL0328HX19) shea butter (UNII: K49155WL9Y) yellow wax (UNII: 2ZA36H0S2V) glycerin (UNII: PDC6A3C0OX) octyldodecanol (UNII: 461N1O614Y) glyceryl isostearate (UNII: HYE7O27HAO) isostearyl alcohol (UNII: Q613OCQ44Y) saccharin sodium (UNII: SB8ZUX40TY) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) .beta.-sitosterol (UNII: S347WMO6M4) petrolatum (UNII: 4T6H12BN9U) butylated hydroxytoluene (UNII: 1P9D0Z171K) cholesterol (UNII: 97C5T2UQ7J) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) ferric oxide yellow (UNII: EX438O2MRT) titanium dioxide (UNII: 15FIX9V2JP) D&C red no. 27 (UNII: 2LRS185U6K) D&C red no. 7 (UNII: ECW0LZ41X8) D&C red no. 21 (UNII: 08744Z6JNY) FD&C yellow no. 5 (UNII: I753WB2F1M) D&C red no. 30 (UNII: 2S42T2808B) FD&C blue no. 1 (UNII: H3R47K3TBD) aluminum oxide (UNII: LMI26O6933) mica (UNII: V8A1AW0880) talc (UNII: 7SEV7J4R1U) cochineal (UNII: TZ8Z31B35M) Product Characteristics Color PINK (ROSADO MAGICO) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-060-02 1 in 1 BOX 1 NDC:13537-060-01 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 09/23/2011 Labeler - Ventura Corporation (San Juan, P.R) (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE
