PUTTISU- titanium dioxide, zinc oxide liquid 
Jellycup, Inc.

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.

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Titanium Dioxide 5.95%, Zinc Oxide 9.70%

Sunscreen

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

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

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

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PUTTISU 
titanium dioxide, zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73419-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.95 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE9.7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
HOUTTUYNIA CORDATA TOP (UNII: 3E4MG0DM0M)  
TANACETUM COCCINEUM FLOWER (UNII: 9BJ3T5AE5X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
TOCOPHEROL (UNII: R0ZB2556P8)  
LIMONIA ACIDISSIMA BARK (UNII: 68SJ7W9Y65)  
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)  
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73419-0001-11 in 1 BOX03/06/2020
115 mL in 1 JAR; Type 0: Not a Combination Product
2NDC:73419-0001-215 mL in 1 JAR; Type 0: Not a Combination Product07/17/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/06/2020
Labeler - Jellycup, Inc. (694888221)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(73419-0001)

Revised: 7/2023
Document Id: 00ab968d-bcd3-1104-e063-6394a90a8dcd
Set id: a032331a-6724-d2cd-e053-2995a90ac15a
Version: 3
Effective Time: 20230717
 
Jellycup, Inc.