Label: ESIKA- titanium dioxide stick
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-037-01, 13537-037-02, 13537-038-01, 13537-038-02, view more13537-039-01, 13537-039-02, 13537-040-01, 13537-040-02, 13537-041-01, 13537-041-02, 13537-042-01, 13537-042-02, 13537-043-01, 13537-043-02, 13537-044-01, 13537-044-02, 13537-045-01, 13537-045-02, 13537-046-01, 13537-046-02, 13537-047-01, 13537-047-02, 13537-048-01, 13537-048-02 - 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
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Inactive Ingredients
Ethylhexyl palmitate, C12-15 alkyl benzoate, caprylic/capric triglyceride, mica, di-ppg-3 myristyl ether adipate, sorbitan isostearate, ozokerite, polyethylene, copernicia cerifera cera (copernicia cerifera (carnauba) wax), polymethyl methacrylate, zea mays (corn) starch, cera alba (beeswax), calendula officinalis flower oil, phenoxyethanol, chitosan, methylparaben, dimethicone, parfum (fragrance), peg-40 hydrogenated castor oil, polysorbate 80, ppg-26-buteth-26, butylparaben, C9-13 fluoroalcohol, ethylparaben, hedera helix extract (hedera helix (ivy) leaf/stem extract), trimethylsiloxysilicate, phosphoric acid, isobutylparaben, propylparaben, tocopheryl acetate, retinyl palmitate, ascorbyl palmitate, bioflavonoids, allantoin, CI 77891 (titanium dioxide), CI 77491 (iron oxides), CI 77492 (iron oxides), CI 77499 (iron oxides).
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 1
- PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 2
- PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 3
- PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 4
- PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 5
- PRINCIPAL DISPLAY PANEL - 2 g Carton - BEIGE 6
- PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 1
- PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 2
- PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 3
- PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 4
- PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 5
- PRINCIPAL DISPLAY PANEL - 2 g Carton - ROSA 6
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INGREDIENTS AND APPEARANCE
ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-037 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.04 g in 1 g Inactive Ingredients Ingredient Name Strength Ethylhexyl palmitate (UNII: 2865993309) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) medium-chain triglycerides (UNII: C9H2L21V7U) mica (UNII: V8A1AW0880) di-ppg-3 myristyl ether adipate (UNII: T32481VTXW) high density polyethylene (UNII: UG00KM4WR7) carnauba wax (UNII: R12CBM0EIZ) starch, corn (UNII: O8232NY3SJ) yellow wax (UNII: 2ZA36H0S2V) calendula officinalis flower (UNII: P0M7O4Y7YD) phenoxyethanol (UNII: HIE492ZZ3T) methylparaben (UNII: A2I8C7HI9T) dimethicone (UNII: 92RU3N3Y1O) polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F) polysorbate 80 (UNII: 6OZP39ZG8H) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) hedera helix top (UNII: 379040L9FW) phosphoric acid (UNII: E4GA8884NN) isobutylparaben (UNII: 0QQJ25X58G) propylparaben (UNII: Z8IX2SC1OH) vitamin a palmitate (UNII: 1D1K0N0VVC) ascorbyl palmitate (UNII: QN83US2B0N) allantoin (UNII: 344S277G0Z) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color BROWN (BEIGE 1) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-037-02 1 in 1 BOX 1 NDC:13537-037-01 2 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 PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-038 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.04 g in 1 g Inactive Ingredients Ingredient Name Strength Ethylhexyl palmitate (UNII: 2865993309) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) medium-chain triglycerides (UNII: C9H2L21V7U) mica (UNII: V8A1AW0880) di-ppg-3 myristyl ether adipate (UNII: T32481VTXW) high density polyethylene (UNII: UG00KM4WR7) carnauba wax (UNII: R12CBM0EIZ) starch, corn (UNII: O8232NY3SJ) yellow wax (UNII: 2ZA36H0S2V) calendula officinalis flower (UNII: P0M7O4Y7YD) phenoxyethanol (UNII: HIE492ZZ3T) methylparaben (UNII: A2I8C7HI9T) dimethicone (UNII: 92RU3N3Y1O) polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F) polysorbate 80 (UNII: 6OZP39ZG8H) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) hedera helix top (UNII: 379040L9FW) phosphoric acid (UNII: E4GA8884NN) isobutylparaben (UNII: 0QQJ25X58G) propylparaben (UNII: Z8IX2SC1OH) vitamin a palmitate (UNII: 1D1K0N0VVC) ascorbyl palmitate (UNII: QN83US2B0N) allantoin (UNII: 344S277G0Z) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color BROWN (BEIGE 2) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-038-02 1 in 1 BOX 1 NDC:13537-038-01 2 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 PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-039 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.04 g in 1 g Inactive Ingredients Ingredient Name Strength Ethylhexyl palmitate (UNII: 2865993309) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) medium-chain triglycerides (UNII: C9H2L21V7U) mica (UNII: V8A1AW0880) di-ppg-3 myristyl ether adipate (UNII: T32481VTXW) high density polyethylene (UNII: UG00KM4WR7) carnauba wax (UNII: R12CBM0EIZ) starch, corn (UNII: O8232NY3SJ) yellow wax (UNII: 2ZA36H0S2V) calendula officinalis flower (UNII: P0M7O4Y7YD) phenoxyethanol (UNII: HIE492ZZ3T) methylparaben (UNII: A2I8C7HI9T) dimethicone (UNII: 92RU3N3Y1O) polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F) polysorbate 80 (UNII: 6OZP39ZG8H) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) hedera helix top (UNII: 379040L9FW) phosphoric acid (UNII: E4GA8884NN) isobutylparaben (UNII: 0QQJ25X58G) propylparaben (UNII: Z8IX2SC1OH) vitamin a palmitate (UNII: 1D1K0N0VVC) ascorbyl palmitate (UNII: QN83US2B0N) allantoin (UNII: 344S277G0Z) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color BROWN (BEIGE 3) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-039-02 1 in 1 BOX 1 NDC:13537-039-01 2 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 PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-040 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.04 g in 1 g Inactive Ingredients Ingredient Name Strength Ethylhexyl palmitate (UNII: 2865993309) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) medium-chain triglycerides (UNII: C9H2L21V7U) mica (UNII: V8A1AW0880) di-ppg-3 myristyl ether adipate (UNII: T32481VTXW) high density polyethylene (UNII: UG00KM4WR7) carnauba wax (UNII: R12CBM0EIZ) starch, corn (UNII: O8232NY3SJ) yellow wax (UNII: 2ZA36H0S2V) calendula officinalis flower (UNII: P0M7O4Y7YD) phenoxyethanol (UNII: HIE492ZZ3T) methylparaben (UNII: A2I8C7HI9T) dimethicone (UNII: 92RU3N3Y1O) polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F) polysorbate 80 (UNII: 6OZP39ZG8H) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) hedera helix top (UNII: 379040L9FW) phosphoric acid (UNII: E4GA8884NN) isobutylparaben (UNII: 0QQJ25X58G) propylparaben (UNII: Z8IX2SC1OH) vitamin a palmitate (UNII: 1D1K0N0VVC) ascorbyl palmitate (UNII: QN83US2B0N) allantoin (UNII: 344S277G0Z) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color BROWN (BEIGE 4) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-040-02 1 in 1 BOX 1 NDC:13537-040-01 2 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 PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-041 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.04 g in 1 g Inactive Ingredients Ingredient Name Strength Ethylhexyl palmitate (UNII: 2865993309) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) medium-chain triglycerides (UNII: C9H2L21V7U) mica (UNII: V8A1AW0880) di-ppg-3 myristyl ether adipate (UNII: T32481VTXW) high density polyethylene (UNII: UG00KM4WR7) carnauba wax (UNII: R12CBM0EIZ) starch, corn (UNII: O8232NY3SJ) yellow wax (UNII: 2ZA36H0S2V) calendula officinalis flower (UNII: P0M7O4Y7YD) phenoxyethanol (UNII: HIE492ZZ3T) methylparaben (UNII: A2I8C7HI9T) dimethicone (UNII: 92RU3N3Y1O) polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F) polysorbate 80 (UNII: 6OZP39ZG8H) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) hedera helix top (UNII: 379040L9FW) phosphoric acid (UNII: E4GA8884NN) isobutylparaben (UNII: 0QQJ25X58G) propylparaben (UNII: Z8IX2SC1OH) vitamin a palmitate (UNII: 1D1K0N0VVC) ascorbyl palmitate (UNII: QN83US2B0N) allantoin (UNII: 344S277G0Z) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color BROWN (BEIGE 5) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-041-02 1 in 1 BOX 1 NDC:13537-041-01 2 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 PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-042 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.04 g in 1 g Inactive Ingredients Ingredient Name Strength Ethylhexyl palmitate (UNII: 2865993309) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) medium-chain triglycerides (UNII: C9H2L21V7U) mica (UNII: V8A1AW0880) di-ppg-3 myristyl ether adipate (UNII: T32481VTXW) high density polyethylene (UNII: UG00KM4WR7) carnauba wax (UNII: R12CBM0EIZ) starch, corn (UNII: O8232NY3SJ) yellow wax (UNII: 2ZA36H0S2V) calendula officinalis flower (UNII: P0M7O4Y7YD) phenoxyethanol (UNII: HIE492ZZ3T) methylparaben (UNII: A2I8C7HI9T) dimethicone (UNII: 92RU3N3Y1O) polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F) polysorbate 80 (UNII: 6OZP39ZG8H) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) hedera helix top (UNII: 379040L9FW) phosphoric acid (UNII: E4GA8884NN) isobutylparaben (UNII: 0QQJ25X58G) propylparaben (UNII: Z8IX2SC1OH) vitamin a palmitate (UNII: 1D1K0N0VVC) ascorbyl palmitate (UNII: QN83US2B0N) allantoin (UNII: 344S277G0Z) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color BROWN (BEIGE 6) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-042-02 1 in 1 BOX 1 NDC:13537-042-01 2 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 PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-043 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.04 g in 1 g Inactive Ingredients Ingredient Name Strength Ethylhexyl palmitate (UNII: 2865993309) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) medium-chain triglycerides (UNII: C9H2L21V7U) mica (UNII: V8A1AW0880) di-ppg-3 myristyl ether adipate (UNII: T32481VTXW) high density polyethylene (UNII: UG00KM4WR7) carnauba wax (UNII: R12CBM0EIZ) starch, corn (UNII: O8232NY3SJ) yellow wax (UNII: 2ZA36H0S2V) calendula officinalis flower (UNII: P0M7O4Y7YD) phenoxyethanol (UNII: HIE492ZZ3T) methylparaben (UNII: A2I8C7HI9T) dimethicone (UNII: 92RU3N3Y1O) polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F) polysorbate 80 (UNII: 6OZP39ZG8H) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) hedera helix top (UNII: 379040L9FW) phosphoric acid (UNII: E4GA8884NN) isobutylparaben (UNII: 0QQJ25X58G) propylparaben (UNII: Z8IX2SC1OH) vitamin a palmitate (UNII: 1D1K0N0VVC) ascorbyl palmitate (UNII: QN83US2B0N) allantoin (UNII: 344S277G0Z) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color RED (ROSA 1) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-043-02 1 in 1 BOX 1 NDC:13537-043-01 2 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 PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-044 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.04 g in 1 g Inactive Ingredients Ingredient Name Strength Ethylhexyl palmitate (UNII: 2865993309) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) medium-chain triglycerides (UNII: C9H2L21V7U) mica (UNII: V8A1AW0880) di-ppg-3 myristyl ether adipate (UNII: T32481VTXW) high density polyethylene (UNII: UG00KM4WR7) carnauba wax (UNII: R12CBM0EIZ) starch, corn (UNII: O8232NY3SJ) yellow wax (UNII: 2ZA36H0S2V) calendula officinalis flower (UNII: P0M7O4Y7YD) phenoxyethanol (UNII: HIE492ZZ3T) methylparaben (UNII: A2I8C7HI9T) dimethicone (UNII: 92RU3N3Y1O) polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F) polysorbate 80 (UNII: 6OZP39ZG8H) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) hedera helix top (UNII: 379040L9FW) phosphoric acid (UNII: E4GA8884NN) isobutylparaben (UNII: 0QQJ25X58G) propylparaben (UNII: Z8IX2SC1OH) vitamin a palmitate (UNII: 1D1K0N0VVC) ascorbyl palmitate (UNII: QN83US2B0N) allantoin (UNII: 344S277G0Z) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color RED (ROSA 2) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-044-02 1 in 1 BOX 1 NDC:13537-044-01 2 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 PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-045 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.04 g in 1 g Inactive Ingredients Ingredient Name Strength Ethylhexyl palmitate (UNII: 2865993309) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) medium-chain triglycerides (UNII: C9H2L21V7U) mica (UNII: V8A1AW0880) di-ppg-3 myristyl ether adipate (UNII: T32481VTXW) high density polyethylene (UNII: UG00KM4WR7) carnauba wax (UNII: R12CBM0EIZ) starch, corn (UNII: O8232NY3SJ) yellow wax (UNII: 2ZA36H0S2V) calendula officinalis flower (UNII: P0M7O4Y7YD) phenoxyethanol (UNII: HIE492ZZ3T) methylparaben (UNII: A2I8C7HI9T) dimethicone (UNII: 92RU3N3Y1O) polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F) polysorbate 80 (UNII: 6OZP39ZG8H) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) hedera helix top (UNII: 379040L9FW) phosphoric acid (UNII: E4GA8884NN) isobutylparaben (UNII: 0QQJ25X58G) propylparaben (UNII: Z8IX2SC1OH) vitamin a palmitate (UNII: 1D1K0N0VVC) ascorbyl palmitate (UNII: QN83US2B0N) allantoin (UNII: 344S277G0Z) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color RED (ROSA 3) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-045-02 1 in 1 BOX 1 NDC:13537-045-01 2 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 PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-046 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.04 g in 1 g Inactive Ingredients Ingredient Name Strength Ethylhexyl palmitate (UNII: 2865993309) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) medium-chain triglycerides (UNII: C9H2L21V7U) mica (UNII: V8A1AW0880) di-ppg-3 myristyl ether adipate (UNII: T32481VTXW) high density polyethylene (UNII: UG00KM4WR7) carnauba wax (UNII: R12CBM0EIZ) starch, corn (UNII: O8232NY3SJ) yellow wax (UNII: 2ZA36H0S2V) calendula officinalis flower (UNII: P0M7O4Y7YD) phenoxyethanol (UNII: HIE492ZZ3T) methylparaben (UNII: A2I8C7HI9T) dimethicone (UNII: 92RU3N3Y1O) polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F) polysorbate 80 (UNII: 6OZP39ZG8H) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) hedera helix top (UNII: 379040L9FW) phosphoric acid (UNII: E4GA8884NN) isobutylparaben (UNII: 0QQJ25X58G) propylparaben (UNII: Z8IX2SC1OH) vitamin a palmitate (UNII: 1D1K0N0VVC) ascorbyl palmitate (UNII: QN83US2B0N) allantoin (UNII: 344S277G0Z) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color RED (ROSA 4) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-046-02 1 in 1 BOX 1 NDC:13537-046-01 2 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 PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-047 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.04 g in 1 g Inactive Ingredients Ingredient Name Strength Ethylhexyl palmitate (UNII: 2865993309) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) medium-chain triglycerides (UNII: C9H2L21V7U) mica (UNII: V8A1AW0880) di-ppg-3 myristyl ether adipate (UNII: T32481VTXW) high density polyethylene (UNII: UG00KM4WR7) carnauba wax (UNII: R12CBM0EIZ) starch, corn (UNII: O8232NY3SJ) yellow wax (UNII: 2ZA36H0S2V) calendula officinalis flower (UNII: P0M7O4Y7YD) phenoxyethanol (UNII: HIE492ZZ3T) methylparaben (UNII: A2I8C7HI9T) dimethicone (UNII: 92RU3N3Y1O) polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F) polysorbate 80 (UNII: 6OZP39ZG8H) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) hedera helix top (UNII: 379040L9FW) phosphoric acid (UNII: E4GA8884NN) isobutylparaben (UNII: 0QQJ25X58G) propylparaben (UNII: Z8IX2SC1OH) vitamin a palmitate (UNII: 1D1K0N0VVC) ascorbyl palmitate (UNII: QN83US2B0N) allantoin (UNII: 344S277G0Z) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color RED (ROSA 5) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-047-02 1 in 1 BOX 1 NDC:13537-047-01 2 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 PERFECT SKIN COVERAGE CONCEALER SPF 17
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-048 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.04 g in 1 g Inactive Ingredients Ingredient Name Strength Ethylhexyl palmitate (UNII: 2865993309) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) medium-chain triglycerides (UNII: C9H2L21V7U) mica (UNII: V8A1AW0880) di-ppg-3 myristyl ether adipate (UNII: T32481VTXW) high density polyethylene (UNII: UG00KM4WR7) carnauba wax (UNII: R12CBM0EIZ) starch, corn (UNII: O8232NY3SJ) yellow wax (UNII: 2ZA36H0S2V) calendula officinalis flower (UNII: P0M7O4Y7YD) phenoxyethanol (UNII: HIE492ZZ3T) methylparaben (UNII: A2I8C7HI9T) dimethicone (UNII: 92RU3N3Y1O) polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F) polysorbate 80 (UNII: 6OZP39ZG8H) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) hedera helix top (UNII: 379040L9FW) phosphoric acid (UNII: E4GA8884NN) isobutylparaben (UNII: 0QQJ25X58G) propylparaben (UNII: Z8IX2SC1OH) vitamin a palmitate (UNII: 1D1K0N0VVC) ascorbyl palmitate (UNII: QN83US2B0N) allantoin (UNII: 344S277G0Z) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color RED (ROSA 6) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-048-02 1 in 1 BOX 1 NDC:13537-048-01 2 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
