TOO COOL FOR SCHOOL DINOPLATZ LOOSE AND SILLY NO. 1 DEFINITION- octinoxate, octisalate, and zinc oxide powder

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 3.75%	Sunscreen
Octisalate 2.50%	Sunscreen
Zinc Oxide 4.80%	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 St. STE 201, Brooklyn, NY 11211

Inactive Ingredients

MICA, SILICA, NYLON-12, SYNTHETIC FLUORPHLOGOPITE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, CAPRYLYL METHICONE, HYDROGENATED LECITHIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE, METHICONE, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, FRAGRANCE/PARFUM, BETULA ALBA JUICE, ROSA CANINA FRUIT OIL, ACRYLATES/TRIDECYL ACRYLATE/TRIETHOXYSILYLPROPYL METHACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, TRIETHOXYCAPRYLYLSILANE, C9-15 FLUOROALCOHOL PHOSPHATE, IRON OXIDES (CI 77491, CI 77492, CI 77499)

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 8 g Bottle Carton

Loose & Silly

Dinoplatz Loose & Silly
Loose setting powder

Broadspectrum spf 27 Sunscreen

8g (0.27oz)

INGREDIENTS AND APPEARANCE

TOO COOL FOR SCHOOL   DINOPLATZ LOOSE AND SILLY NO. 1 DEFINITION
octinoxate, octisalate, and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69926-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	3.75 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	2.5 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	4.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
BETULA PUBESCENS RESIN (UNII: 9G931M6I4G)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69926-004-02	1 in 1 CARTON
1	NDC: 69926-004-01	8 g in 1 BOTTLE, 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

Labeler - Too Cool For School USA, Inc (079860981)

Establishment
Name	Address	ID/FEI	Business Operations
KOLMAR KOREA Co.,Ltd		688732723	MANUFACTURE(69926-004)