Clapiel Defense Sunblock

Manufacturer
AUS KOREA CO., LTD.
Effective date
2015-07-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:43:09

Label at a glance#

ProductClapiel Defense Sunblock
Active ingredientOCTINOXATE, ZINC OXIDE, OCTISALATE, TITANIUM DIOXIDE
Label structure6 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: ETHYLHEXYL METHOXYCINNAMATE 6.80%, ZINC OXIDE 5.00%, ETHYLHEXYL SALICYLATE 4.50%, TITANIUM DIOXIDE 4.00%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Cyclopentasiloxane, Dipropylene Glycol, Peg-10 Dimethicone, Dicaprylyl Carbonate, Niacinamide, Disteardimonium Hectorite, Dimethicone, Magnesium Sulfate, Aluminum Hydroxide, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Phenoxyethanol, Viscum Album (Mistletoe) Leaf Extract, Centella Asiatica Extract, Portulaca Oleracea Extract, Stearic Acid, Fragrance, Polymethylsilsesquioxane, Methicone, Caprylyl Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, PEG-9 Plydimethylsiloxyethyl Dimethicone, Actinidia Chinensis (Kiwi) Fruit Extract, Camellia Sinensis Callus Culture Extract, Cucurbita Pepo (Pumpkin) Fruit Extract, Daucus Carota Sativa (Carrot) Root Extract, Glyceryl Caprylate, Mangifera Indica (Mango) Fruit Extract, Polyglyceryl-6 Plyricinoleate, Tocopheryl Acetate, Sodium Hyaluronate

PURPOSE

OTC - PURPOSE SECTION

Purpose: Sunscreen

WARNINGS

WARNINGS SECTION

Warnings: 1. In case of having following symptoms after using this, you’re advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

Keep out of reach of children: Keep out of reach of babies and children

DESCRIPTION

DESCRIPTION SECTION

Indications & Usage: Apply a desired amount evenly over entire face.

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69977-050-012020-01-31C16284748780-19d75b9d0-9ea4-f424-e053-dadaa90a57ce6c2e804c-ea39-4771-8ff6-c6ff93234794

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69977-050-01Clapiel Defense Sunblock50 mL in 1 CARTONCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69977-050CLAPIEL DEFENSE SUNBLOCK (OCTINOXATE, ZINC OXIDE, OCTISALATE, TITANIUM DIOXIDE) CREAM [AUS KOREA CO., LTD.]1Legacy NDC, 1 package rows20150724_6c2e804c-ea39-4771-8ff6-c6ff93234794.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ZINC CATIONACTIVE MOIETY13S1S8SF371
Dipropylene GlycolINACTIVE INGREDIENTE107L85C401
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69977-05069977-050-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Dipropylene GlycolDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
3 equally ranked IID candidates
Dipropylene GlycolDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / TRANSDERMAL296 mgExact identifier — unii candidate
3 equally ranked IID candidates
Dipropylene GlycolDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
3 equally ranked IID candidates

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
3173e183-37cc-49ae-a61b-09165c24d6b06c2e804c-ea39-4771-8ff6-c6ff932347942015-07-24WarningsExact identifier
spl id: 3173e183-37cc-49ae-a61b-09165c24d6b0
spl set id: 6c2e804c-ea39-4771-8ff6-c6ff93234794

Reported adverse events (FAERS/openFDA)#

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