PUTTISU- titanium dioxide, zinc oxide liquid

Puttisu by

Drug Labeling and Warnings

Puttisu by is a Otc medication manufactured, distributed, or labeled by Jellycup, Inc., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 5.95%, Zinc Oxide 9.70%

PURPOSE

Sunscreen

INDICATIONS & USAGE

• 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 AND PRECAUTIONS

• For external use only
• Do not use on damaged or broken skin

WHEN USING

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

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

DOSAGE & ADMINISTRATION

• Applying liberally an evenly 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating
• Sun Protection Measures
• spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or high and other sun protection measures including:
• limit time in the sun, especially from 10 am-2 pm
• wear long-sleeved shirts, pants, hats, and sunglasses
• children under 6 months age: Ask a doctor

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENT

WATER

ETHYLHEXYL PALMITATE

ETHYLHEXYL STEARATE

BUTYLENE GLYCOL

BUTYLOCTYL SALICYLATE

CAPRYLYL TRISILOXANE

DIPHENYLSILOXY PHENYL TRIMETHICONE

POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)

ALKYL (C12-15) BENZOATE

DICAPRYLYL CARBONATE

LIMONIA ACIDISSIMA BARK

ZANTHOXYLUM PIPERITUM FRUIT PULP

GREEN TEA LEAF

YEAST, UNSPECIFIED

HOUTTUYNIA CORDATA TOP

TANACETUM COCCINEUM FLOWER

NYMPHAEA ALBA FLOWER

CORYMBIA CITRIODORA LEAF OIL

POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE

POLYHYDROXYSTEARIC ACID STEARATE

POLYMETHYLSILSESQUIOXANE (11 MICRONS)

SODIUM CHLORIDE

VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER

SILICON DIOXIDE

DISTEARDIMONIUM HECTORITE

TRIETHOXYCAPRYLYLSILANE

CAPRYLYL GLYCOL

GLYCERYL CAPRYLATE

DIMETHICONE

ALLANTOIN

TOCOPHEROL

DIPROPYLENE GLYCOL

SODIUM PALMITOYL PROLINE

DISODIUM EDTA-COPPER

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PUTTISU 
titanium dioxide, zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73419-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5.95 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9.7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ZANTHOXYLUM PIPERITUM FRUIT PULP (UNII: 7PFC2VA251)
CORYMBIA CITRIODORA LEAF OIL (UNII: M63U6N96EB)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ALLANTOIN (UNII: 344S277G0Z)
SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
HOUTTUYNIA CORDATA TOP (UNII: 3E4MG0DM0M)
TANACETUM COCCINEUM FLOWER (UNII: 9BJ3T5AE5X)
LIMONIA ACIDISSIMA BARK (UNII: 68SJ7W9Y65)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73419-0001-1	1 in 1 BOX	03/06/2020
1		15 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/06/2020

Labeler - Jellycup, Inc. (694888221)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(73419-0001)