Label: PUTTISU- titanium dioxide, zinc oxide liquid

  • NDC Code(s): 73419-0001-1, 73419-0001-2
  • Packager: Jellycup, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 17, 2023

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  • 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

    label1label2label3label4

  • INGREDIENTS AND APPEARANCE
    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)
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