Label: TOO COOL FOR SCHOOL DINOPLATZ LA OLA VIENTO NO.21- ensulizole, octinoxate, octocrylene, and titanium dioxide kit
TOO COOL FOR SCHOOL DINOPLATZ LA OLA NOCHE NO.23- ensulizole, octinoxate, octocrylene, and titanium dioxide kit
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Contains inactivated NDC Code(s)
NDC Code(s): 69926-008-01, 69926-009-01 - Packager: Too Cool For School USA, Inc
- 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 31, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- –
- Limit time in the sun, especially from 10 a.m.-2 p.m.
- –
- Wear long-sleeved shirts, pants, hats and sunglasses
- Children under 6 months : Ask a doctor
- Other information
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Inactive Ingredients
SEA WATER/EAU DE MER, TRIETHYLHEXANOIN, C12-15 ALKYL BENZOATE, GLYCERIN, DIMETHICONE, OZOKERITE, CERESIN, BUTYLENE GLYCOL, NIACINAMIDE, TRIETHANOLAMINE, SUCROSE TETRASTEARATE TRIACETATE, POLYMETHYL METHACRYLATE, HYDROGENATED POLYISOBUTENE, PHENYL TRIMETHICONE, SODIUM CHLORIDE, CETYL PEG/PPG-10/1 DIMETHICONE, SYNTHETIC FLUORPHLOGOPITE, MICROCRYSTALLINE WAX/ CIRE MICROCRISTALLINE, SORBITAN OLIVATE, SQUALANE, ETHYL HEXANEDIOL, SILICA, METHICONE, GLYCERYL CAPRYLATE, MAGNESIUM STEARATE, SORBITAN SESQUIOLEATE, FRAGRANCE/PARFUM, TRIETHOXYCAPRYLYLSILANE, ALUMINUM HYDROXIDE, ADENOSINE, HYDROLYZED COLLAGEN, ARTEMIA EXTRACT, UNDARIA PINNATIFIDA EXTRACT, LAMINARIA DIGITATA EXTRACT, IRON OXIDES (CI 77491, CI 77492, CI 77499)
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - #21 Kit Carton
- PRINCIPAL DISPLAY PANEL - #23 Kit Carton
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INGREDIENTS AND APPEARANCE
TOO COOL FOR SCHOOL DINOPLATZ LA OLA VIENTO NO.21
ensulizole, octinoxate, octocrylene, and titanium dioxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69926-008 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69926-008-01 1 in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 CONTAINER 13 g Part 2 1 CONTAINER 1 g Part 3 1 CONTAINER 1 g Part 4 1 CONTAINER 1 g Part 1 of 4 BB FOUNDATION
ensulizole, octinoxate, octocrylene, and titanium dioxide creamProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 20 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 20 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 30 mg in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 96.9 mg in 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) CERESIN (UNII: Q1LS2UJO3A) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) NIACINAMIDE (UNII: 25X51I8RD4) TROLAMINE (UNII: 9O3K93S3TK) SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) SORBITAN OLIVATE (UNII: MDL271E3GR) SQUALANE (UNII: GW89575KF9) ETHOHEXADIOL (UNII: M9JGK7U88V) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) MAGNESIUM STEARATE (UNII: 70097M6I30) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ADENOSINE (UNII: K72T3FS567) UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S) LAMINARIA DIGITATA (UNII: 15E7C67EE8) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 13 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 09/01/2015 Part 2 of 4 CONCEALER
foundations creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) INGR MICA (UNII: V8A1AW0880) INGR DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) INGR ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) INGR YELLOW WAX (UNII: 2ZA36H0S2V) INGR SILICON DIOXIDE (UNII: ETJ7Z6XBU4) INGR HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR SORBITAN OLIVATE (UNII: MDL271E3GR) INGR SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) INGR MINERAL OIL (UNII: T5L8T28FGP) INGR CARNAUBA WAX (UNII: R12CBM0EIZ) INGR CANDELILLA WAX (UNII: WL0328HX19) INGR NYLON-12 (UNII: 446U8J075B) INGR PARAFFIN (UNII: I9O0E3H2ZE) INGR HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) INGR ETHOHEXADIOL (UNII: M9JGK7U88V) INGR ALUMINUM OXIDE (UNII: LMI26O6933) INGR GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) INGR TITANIUM DIOXIDE (UNII: 15FIX9V2JP) INGR FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 09/01/2015 Part 3 of 4 PORE BALM
makeup bases creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR MICA (UNII: V8A1AW0880) INGR SILICON DIOXIDE (UNII: ETJ7Z6XBU4) INGR ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) INGR MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) INGR CERESIN (UNII: Q1LS2UJO3A) INGR METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P) INGR PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) INGR SORBITAN OLIVATE (UNII: MDL271E3GR) INGR SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N) INGR CARNAUBA WAX (UNII: R12CBM0EIZ) INGR CANDELILLA WAX (UNII: WL0328HX19) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR TITANIUM DIOXIDE (UNII: 15FIX9V2JP) INGR FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 09/01/2015 Part 4 of 4 LIP AND CHEEK
lipstick creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) INGR ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) INGR CERESIN (UNII: Q1LS2UJO3A) INGR SILICON DIOXIDE (UNII: ETJ7Z6XBU4) INGR MICA (UNII: V8A1AW0880) INGR DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) INGR POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A) INGR PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) INGR SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N) INGR CARNAUBA WAX (UNII: R12CBM0EIZ) INGR YELLOW WAX (UNII: 2ZA36H0S2V) INGR CASTOR OIL (UNII: D5340Y2I9G) INGR OCTYLDODECANOL (UNII: 461N1O614Y) INGR OLEYL ALCOHOL (UNII: 172F2WN8DV) INGR SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) INGR MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) INGR DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) INGR BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) INGR ROSIN (UNII: 88S87KL877) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) INGR OCTYLDODECYL MYRISTATE (UNII: S013N99GR8) INGR TALC (UNII: 7SEV7J4R1U) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR BUTYLPARABEN (UNII: 3QPI1U3FV8) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR TITANIUM DIOXIDE (UNII: 15FIX9V2JP) INGR D&C RED NO. 30 (UNII: 2S42T2808B) INGR ALUMINUM OXIDE (UNII: LMI26O6933) INGR FD&C YELLOW NO. 5 (UNII: I753WB2F1M) INGR FD&C YELLOW NO. 6 (UNII: H77VEI93A8) INGR D&C RED NO. 6 (UNII: 481744AI4O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 09/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/01/2015 TOO COOL FOR SCHOOL DINOPLATZ LA OLA NOCHE NO.23
ensulizole, octinoxate, octocrylene, and titanium dioxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69926-009 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69926-009-01 1 in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 CONTAINER 13 g Part 2 1 CONTAINER 1 g Part 3 1 CONTAINER 1 g Part 4 1 CONTAINER 1 g Part 1 of 4 BB FOUNDATION
ensulizole, octinoxate, octocrylene, and titanium dioxide creamProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 20 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 20 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 30 mg in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 96.9 mg in 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) CERESIN (UNII: Q1LS2UJO3A) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) NIACINAMIDE (UNII: 25X51I8RD4) TROLAMINE (UNII: 9O3K93S3TK) SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) SORBITAN OLIVATE (UNII: MDL271E3GR) SQUALANE (UNII: GW89575KF9) ETHOHEXADIOL (UNII: M9JGK7U88V) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) MAGNESIUM STEARATE (UNII: 70097M6I30) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ADENOSINE (UNII: K72T3FS567) UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S) LAMINARIA DIGITATA (UNII: 15E7C67EE8) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 13 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 09/01/2015 Part 2 of 4 CONCEALER
foundations creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) INGR MICA (UNII: V8A1AW0880) INGR DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) INGR ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) INGR YELLOW WAX (UNII: 2ZA36H0S2V) INGR SILICON DIOXIDE (UNII: ETJ7Z6XBU4) INGR HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR SORBITAN OLIVATE (UNII: MDL271E3GR) INGR SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) INGR MINERAL OIL (UNII: T5L8T28FGP) INGR CARNAUBA WAX (UNII: R12CBM0EIZ) INGR CANDELILLA WAX (UNII: WL0328HX19) INGR NYLON-12 (UNII: 446U8J075B) INGR PARAFFIN (UNII: I9O0E3H2ZE) INGR HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) INGR ETHOHEXADIOL (UNII: M9JGK7U88V) INGR ALUMINUM OXIDE (UNII: LMI26O6933) INGR GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) INGR TITANIUM DIOXIDE (UNII: 15FIX9V2JP) INGR FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 09/01/2015 Part 3 of 4 PORE BALM
makeup bases creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR MICA (UNII: V8A1AW0880) INGR SILICON DIOXIDE (UNII: ETJ7Z6XBU4) INGR ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) INGR MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) INGR CERESIN (UNII: Q1LS2UJO3A) INGR METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P) INGR PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) INGR SORBITAN OLIVATE (UNII: MDL271E3GR) INGR SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N) INGR CARNAUBA WAX (UNII: R12CBM0EIZ) INGR CANDELILLA WAX (UNII: WL0328HX19) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR TITANIUM DIOXIDE (UNII: 15FIX9V2JP) INGR FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 09/01/2015 Part 4 of 4 LIP AND CHEEK
lipstick creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) INGR ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) INGR CERESIN (UNII: Q1LS2UJO3A) INGR SILICON DIOXIDE (UNII: ETJ7Z6XBU4) INGR MICA (UNII: V8A1AW0880) INGR DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) INGR POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A) INGR PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) INGR SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N) INGR CARNAUBA WAX (UNII: R12CBM0EIZ) INGR YELLOW WAX (UNII: 2ZA36H0S2V) INGR CASTOR OIL (UNII: D5340Y2I9G) INGR OCTYLDODECANOL (UNII: 461N1O614Y) INGR OLEYL ALCOHOL (UNII: 172F2WN8DV) INGR SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) INGR MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) INGR DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) INGR BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) INGR ROSIN (UNII: 88S87KL877) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) INGR OCTYLDODECYL MYRISTATE (UNII: S013N99GR8) INGR TALC (UNII: 7SEV7J4R1U) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR BUTYLPARABEN (UNII: 3QPI1U3FV8) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR TITANIUM DIOXIDE (UNII: 15FIX9V2JP) INGR D&C RED NO. 30 (UNII: 2S42T2808B) INGR ALUMINUM OXIDE (UNII: LMI26O6933) INGR FD&C YELLOW NO. 5 (UNII: I753WB2F1M) INGR FD&C YELLOW NO. 6 (UNII: H77VEI93A8) INGR D&C RED NO. 6 (UNII: 481744AI4O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 09/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/01/2015 Labeler - Too Cool For School USA, Inc (079860981) Establishment Name Address ID/FEI Business Operations Hanbul Cosmetics Co., Ltd. 687817395 MANUFACTURE(69926-008, 69926-009)
