FDA.reportPublic FDA data

TONYMOLY My Sunny Waterproof Sun Block

Manufacturer
Tonymoly Co., Ltd. | Kolmar
Effective date
2016-02-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 22:44:50

Label at a glance#

ProductTONYMOLY My Sunny Waterproof Sun Block
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure8 sections

Dosage and administration

During the last step of basic skin care, dispense an appropriate amount and evenly apply to any skin that will be exposed to ultraviolet sunlight.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Dipropylene Glycol 4.00%, Glycerin 2.00%, Titanium Dioxide 3.51%, Zinc Oxide 13.44%

Purpose

OTC - PURPOSE SECTION

Sunscreen SPF50++

Use

INTENDED USE OF THE DEVICE

This perfect sun block uses a strong UV protection system that is resistant against water, sweat, and sebum secretion. It is gentle on skin and protects the skin from harmful external factors when exposed to the outdoors.

Caution

WARNINGS SECTION

For external use only. Avoid contact with eyes. Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

Directions

INDICATIONS & USAGE SECTION

During the last step of basic skin care, dispense an appropriate amount and evenly apply to any skin that will be exposed to ultraviolet sunlight.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER, CYCLOPENTASILOXANE, PEG-10 DIMETHICONE, BUTYLOCTYL SALICYLATE, DICAPRYLYL CARBONATE, BIOSACCHARIDE GUM-1, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, METHYL METHACRYLATE CROSSPOLYMER, METHICONE, PORTULACA OLERACEA EXTRACT, ALUMINUM HYDROXIDE, DIMETHICONE, PHENOXYETHANOL, CALCIUM ALUMINUM BOROSILICATE, FRAGRANCE, STEARIC ACID, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, POLYGLYCERYL-6 POLYRICINOLEATE, TOCOPHERYL ACETATE, MICROCRYSTALLINE CELLULOSE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, CHAMAECYPARIS OBTUSA LEAF EXTRACT, ORIGANUM VULGARE LEAF EXTRACT, SALIX ALBA (WILLOW) BARK EXTRACT, CELLULOSE GUM, CINNAMOMUM CASSIA BARK EXTRACT, LACTOBACILLUS/SOYBEAN FERMENT EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, NYMPHAEA ALBA FLOWER EXTRACT, ALOE BARBADENSIS LEAF JUICE, GLYCERYL POLYMETHACRYLATE, PROPYLENE GLYCOL, PLATINUM POWDER, POLYSORBATE 80

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59078-108-022020-01-31C16284748780-19d75b9d0-d7f2-f424-e053-dadaa90a57ce2964e6c5-6ce1-3052-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59078-108-02TONYMOLY My Sunny Waterproof Sun Block1 in 1 CARTONCREAM15
59078-108-02TONYMOLY My Sunny Waterproof Sun Block60 g in 1 TUBECREAM605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59078-108TONYMOLY MY SUNNY WATERPROOF SUN BLOCK (ZINC OXIDE) CREAM [TONYMOLY CO., LTD.]5Legacy NDC, 2 package rows20160203_2964e6c5-6ce1-3052-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59078-10859078-108-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
WILLOW BARKS883J9JDYXIACT
CYCLOMETHICONE 50THT5PCI0RIACT
PORTULACA OLERACEA WHOLED5J3623SV2IACT
CHAMAECYPARIS OBTUSA LEAF7OL154J5XBIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
NYMPHAEA ALBA FLOWER40KQ7Q535OIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
BIOSACCHARIDE GUM-1BB4PU4V09HIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
POLYSORBATE 806OZP39ZG8HIACT
MAGNESIUM SULFATEDE08037SABIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARIC ACID4ELV7Z65APIACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
CALCIUM ALUMINUM BOROSILICATE3JRB8A35M0IACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
ALOE VERA LEAFZY81Z83H0XIACT

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
2ad097f6-6547-67d0-e054-00144ff8d46c2964e6c5-6ce1-3052-e054-00144ff8d46c2016-02-02WarningsExact identifier
spl id: 2ad097f6-6547-67d0-e054-00144ff8d46c
spl set id: 2964e6c5-6ce1-3052-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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