Puttisu: Package Insert and Label Information

PUTTISU- zinc oxide and titanium dioxide 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.

Titanium Dioxide 5.95%, Zinc Oxide 9.70%

Sunscreen

  • 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.
  • 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

  • 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

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

label 2
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label
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PUTTISU
titanium dioxide, zinc oxide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73419-0001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 5.95 g in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 9.7 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)
ALKYL (C12-15) BENZOATE
ZANTHOXYLUM PIPERITUM FRUIT PULP
CORYMBIA CITRIODORA LEAF OIL
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
ALLANTOIN
SODIUM PALMITOYL PROLINE (PROLINE)
SODIUM CHLORIDE
TRIETHOXYCAPRYLYLSILANE
CAPRYLYL GLYCOL
GLYCERYL CAPRYLATE
DISODIUM EDTA-COPPER (CUPRIC CATION)
ETHYLHEXYL STEARATE
WATER
ETHYLHEXYL PALMITATE
BUTYLENE GLYCOL
BUTYLOCTYL SALICYLATE
SILICON DIOXIDE
POLYHYDROXYSTEARIC ACID STEARATE
POLYMETHYLSILSESQUIOXANE (11 MICRONS)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER
GREEN TEA LEAF
YEAST, UNSPECIFIED
HOUTTUYNIA CORDATA TOP
TANACETUM COCCINEUM FLOWER
LIMONIA ACIDISSIMA BARK
DICAPRYLYL CARBONATE
CAPRYLYL TRISILOXANE
DIPHENYLSILOXY PHENYL TRIMETHICONE
DIMETHICONE
DIPROPYLENE GLYCOL
DISTEARDIMONIUM HECTORITE
TOCOPHEROL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73419-0001-1 1 JAR in 1 BOX contains a JAR
1 15 mL in 1 JAR This package is contained within the BOX (73419-0001-1)
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 Operations
Cosmax, Inc. 689049693 manufacture (73419-0001)

Revised: 03/2020 Jellycup, Inc.

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