TOO COOL FOR SCHOOL DINO PLATZ CINEMA CITY (CC CHEEK)- octinoxate, octisalate, titanium dioxide, and zinc oxide kit

Too Cool For School by

Drug Labeling and Warnings

Too Cool For School by is a Otc medication manufactured, distributed, or labeled by Too Cool For School USA, Inc, KOLMAR KOREA Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Octinoxate 6.00%	Sunscreen
Octisalate 2.00%	Sunscreen
Titanium Dioxide 5.6%	Sunscreen
Zinc Oxide 1.92%	Sunscreen

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

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

• Protect the product in this container from excessive heat and direct sunlight.
• You may report a serious adverse event from use of this product to: Too Cool For School USA INC.181 North 11th Street Suite 201, Brooklyn, NY 11211

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

Dist. by ©Too Cool For School USA Inc.
Brooklyn, NY 11211

PRINCIPAL DISPLAY PANEL - Kit carton

Dinoplatz Cinema City

CC Cream with
Broadspectrum
SPF 30 Sunscreen
and Cheek

Cing Cong

INGREDIENTS AND APPEARANCE

TOO COOL FOR SCHOOL  DINO PLATZ CINEMA CITY (CC CHEEK)
octinoxate, octisalate, titanium dioxide, and zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69926-002

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69926-002-01	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 cream

Product 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  BLUSHER
blushers (all types) stick

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
INGR	MICA (UNII: V8A1AW0880)
INGR	POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)
INGR	SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
INGR	ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)
INGR	PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
INGR	CERESIN (UNII: Q1LS2UJO3A)
INGR	HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
INGR	DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
INGR	TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
INGR	VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	CANDELILLA WAX (UNII: WL0328HX19)
INGR	MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
INGR	SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
INGR	GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
INGR	ALUMINUM OXIDE (UNII: LMI26O6933)
INGR	D&C RED NO. 6 (UNII: 481744AI4O)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor		Imprint Code
Contains

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(69926-002)