Label: TOO COOL FOR SCHOOL DINO PLATZ CINEMA CITY (CC CONCEALER)- octinoxate, octisalate, titanium dioxide, and zinc oxide kit
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Contains inactivated NDC Code(s)
NDC Code(s): 69926-003-02 - 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 June 29, 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.
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- Wear long-sleeved shirts, pants, hats and sunglasses
- Children under 6 months : Ask a doctor
- Other information
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Inactive Ingredients
WATER/EAU, CYCLOPENTASILOXANE, GLYCERIN, PROPYLENE GLYCOL, CAPRYLYL METHICONE, PEG-10 DIMETHICONE, ISOHEXADECANE, NIACINAMIDE, PHENYL TRIMETHICONE, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, TALC, DISTEARDIMONIUM HECTORITE, SILICA, MAGNESIUM SULFATE, C12-14 PARETH-3, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, PHENOXYETHANOL, TRIBEHENIN, DIMETHICONE, ALUMINUM HYDROXIDE, METHICONE, ALUMINUM STEARATE, FRAGRANCE, ETHYLHEXYLGLYCERIN, TOCOPHERYL ACETATE, POLYURETHANE-11, ADENOSINE, AMINOPROPYL DIMETHICONE, POLYMETHYLSILSEQUIOXANE, ARGANIA SPINOSA KERNEL OIL, IMPERATE CYLINDRICA ROOT EXTRACT, PRUNUS ARMENIACA (APRICOT) KERNEL OIL, PSEUDOAL TEROMONAS FERMENT EXTRACT, IRON OXIDES (CI 77491, CI 77492, CI 77499)
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
TOO COOL FOR SCHOOL DINO PLATZ CINEMA CITY (CC CONCEALER)
octinoxate, octisalate, titanium dioxide, and zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69926-003 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69926-003-02 1 in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE, WITH APPLICATOR 30 mL Part 2 1 CONTAINER 2.8 g Part 1 of 2 TOO COOL FOR SCHOOL CC
octinoxate, octisalate, titanium dioxide, and zinc oxide creamProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 60 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 20 mg in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 56 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 19.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) ISOHEXADECANE (UNII: 918X1OUF1E) NIACINAMIDE (UNII: 25X51I8RD4) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) ALMOND OIL (UNII: 66YXD4DKO9) TALC (UNII: 7SEV7J4R1U) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM SULFATE (UNII: DE08037SAB) C12-14 PARETH-3 (UNII: 93RY22U87E) PHENOXYETHANOL (UNII: HIE492ZZ3T) TRIBEHENIN (UNII: 8OC9U7TQZ0) DIMETHICONE (UNII: 92RU3N3Y1O) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM STEARATE (UNII: U6XF9NP8HM) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ADENOSINE (UNII: K72T3FS567) ARGAN OIL (UNII: 4V59G5UW9X) APRICOT KERNEL OIL (UNII: 54JB35T06A) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 mL in 1 TUBE, WITH APPLICATOR; 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 2 TOO COOL FOR SCHOOL CONCEALER
foundations stickProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR TITANIUM DIOXIDE (UNII: 15FIX9V2JP) INGR HEXYL LAURATE (UNII: 4CG9F9W01Q) INGR ZINC OXIDE (UNII: SOI2LOH54Z) INGR CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) INGR HEXYLDECYL MYRISTOYL METHYLAMINOPROPIONATE (UNII: 1959TW0O9A) INGR HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) INGR OCTYLDODECANOL (UNII: 461N1O614Y) INGR C30-45 ALKYL METHICONE (UNII: NFX970DSI2) INGR CANDELILLA WAX (UNII: WL0328HX19) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) INGR LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) INGR SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) INGR DIMER DILINOLEYL DIMER DILINOLEATE (UNII: 0E2D5DBT7M) INGR ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) INGR ALUMINUM OXIDE (UNII: LMI26O6933) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR SILICON DIOXIDE (UNII: ETJ7Z6XBU4) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) INGR FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2.8 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 KOLMAR KOREA Co.,Ltd 688732723 MANUFACTURE(69926-003)
