FDA.reportPublic FDA data

Homme Aqua Sun Block SPF50 Plus PA 2Plus

Manufacturer
WIZCOZ CORPORATION LTD
Effective date
2011-12-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:26

Label at a glance#

ProductHomme Aqua Sun Block SPF50 Plus PA 2Plus
Active ingredientOCTINOXATE, OCTISALATE, ENSULIZOLE, BEMOTRIZINOL, AVOBENZONE
Label structure11 sections

Storage and handling

Storage: Keep in a cool, dry place away from heat and direct sunlight

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Purpose: Sunscreen

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Octinoxate 7.50%, Octisalate 5.00%, Ensulizole 4.00%, Bemotrizinol 3.00%, Avobenzone 3.00%

OTC - WHEN USING SECTION

When using this product: Do not use other than directed

OTC - DO NOT USE SECTION

Do Not Use: On wounds, rashes, dermatitis or damaged skin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children: If swallowed, get medical help or contact a Poison Control Center immediately

OTC - STOP USE SECTION

Stop Use: Please stop using this product and contact a dermatologist.
                1. If red rash, swelling, itch or irritation occurs
                2. If direct sunlight affects the area as above

WARNINGS SECTION

Warnings: For external use only.  Do not use other than directed.  Keep the lid back on after using

STORAGE AND HANDLING SECTION

Storage: Keep in a cool, dry place away from heat and direct sunlight

DESCRIPTION SECTION

Direction:  
Step 1: Clean and dry your face
Step 2: Use the basic skincare products
Step 3: Use small amount of it and apply evenly and thoroughly to your face
                

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Chlorphenesin, Edetate Disodium, Methylparaben, Propylparaben

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box Label
Box Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49715-013-432019-11-13C16284748780-197449f38-cbcf-f6ea-e053-dbdaa90aa7035625e12e-3e3b-4268-a21a-c2800753f7e8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49715-013-43Homme Aqua Sun Block SPF50 Plus PA 2Plus43.5 g in 1 BOTTLE, PLASTICCREAM43.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49715-013HOMME AQUA SUN BLOCK SPF50 PLUS PA 2PLUS (OCTINOXATE, OCTISALATE, ENSULIZOLE, BEMOTRIZINOL, AVOBENZONE) CREAM [WIZCOZ CORPORATION LTD]1Legacy NDC, 1 package rows20111223_5625e12e-3e3b-4268-a21a-c2800753f7e8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
BEMOTRIZINOLACTIVE INGREDIENTPWZ1720CBH1
ENSULIZOLEACTIVE INGREDIENT9YQ9DI1W421
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
BEMOTRIZINOLACTIVE MOIETYPWZ1720CBH1
ENSULIZOLEACTIVE MOIETY9YQ9DI1W421
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49715-01349715-013-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
ENSULIZOLE9YQ9DI1W42ACTIB
BEMOTRIZINOLPWZ1720CBHACTIB
AVOBENZONEG63QQF2NOXACTIB
CHLORPHENESINI670DAL4SZIACT
EDETATE DISODIUM7FLD91C86KIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT

Source Document#

Source XML · Source PDF

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
9177a2ba-206e-4c0a-b5b0-3a164508f7e35625e12e-3e3b-4268-a21a-c2800753f7e82011-12-01WarningsExact identifier
spl id: 9177a2ba-206e-4c0a-b5b0-3a164508f7e3
spl set id: 5625e12e-3e3b-4268-a21a-c2800753f7e8

Reported adverse events (FAERS/openFDA)#

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