FDA.reportPublic FDA data

Puttisu

Manufacturer
Jellycup, Inc. | Cosmax, Inc.
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:47:40

Label at a glance#

ProductPuttisu
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 5.95%, Zinc Oxide 9.70%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

  • 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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

DOSAGE & ADMINISTRATION SECTION

  • 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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label1label1label2label2label3label3label4label4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73419-0001-1Puttisu1 in 1 BOXLIQUID14
73419-0001-1Puttisu15 mL in 1 JARLIQUID154
73419-0001-2Puttisu15 mL in 1 JARLIQUID154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73419-0001PUTTISU (TITANIUM DIOXIDE, ZINC OXIDE) LIQUID [JELLYCUP, INC.]4Current NDC, Legacy NDC, 3 package rows20241222_a032331a-6724-d2cd-e053-2995a90ac15a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73419-000173419-0001-1, 73419-0001-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
POLYMETHYLSILSESQUIOXANE (11 MICRONS)Z570VEV8XKIACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
DIPHENYLSILOXY PHENYL TRIMETHICONEI445L28B12IACT
DIMETHICONE92RU3N3Y1OIACT
DIPROPYLENE GLYCOLE107L85C40IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
HOUTTUYNIA CORDATA TOP3E4MG0DM0MIACT
TANACETUM COCCINEUM FLOWER9BJ3T5AE5XIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
TOCOPHEROLR0ZB2556P8IACT
LIMONIA ACIDISSIMA BARK68SJ7W9Y65IACT
ZINC OXIDESOI2LOH54ZACTIB
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ZANTHOXYLUM PIPERITUM FRUIT PULP7PFC2VA251IACT
CORYMBIA CITRIODORA LEAF OILM63U6N96EBIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
ALLANTOIN344S277G0ZIACT
SODIUM PALMITOYL PROLINE64L053FRFOIACT
SODIUM CHLORIDE451W47IQ8XIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
DISODIUM EDTA-COPPER6V475AX06UIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
ETHYLHEXYL PALMITATE2865993309IACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PuttisuTITANIUM DIOXIDE, ZINC OXIDEJellycup, Inc.a032331a-6724-d2cd-e053-2995a90ac15a2024-12-19WarningsExact identifier
ndc (package): 73419-0001-1
ndc (package): 73419-0001-2
ndc (product): 73419-0001
ndc11 (package): 73419000101
ndc11 (package): 73419000102
spl id: 299b6570-07cb-c9ee-e063-6394a90afff0
spl set id: a032331a-6724-d2cd-e053-2995a90ac15a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.