CIZAR Aqua Sun

Manufacturer
Tissuegene,inc | Cosmax, Inc.
Effective date
2018-12-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:57:41

Label at a glance#

ProductCIZAR Aqua Sun
Active ingredientHomosalate, Octocrylene, Octisalate, Avobenzone
Label structure6 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Homosalate 9.5 %, Octocrylene 5.0 %, Ethylhexyl Salicylate 4.5 %, Butyl Methoxydibenzoylmethane 3.0 %

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients: Water, Butylene Glycol, Butyloctyl Salicylate, Dipropylene Glycol, Glycerin, Alcohol Denat., Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylyl Methicone, Dimethicone, Cetearyl Alcohol, Triceteareth-4 Phosphate, Glyceryl Stearate, PEG-100 Stearate, Glycol Stearate, Methyl Methacrylate Crosspolymer, PEG-2 Stearate, Potassium Cetyl Phosphate, Hydrolyzed Wheat Protein/PVP Crosspolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Phenoxyethanol, Caprylyl Glycol, Glyceryl Caprylate, Lavandula Angustifolia (Lavender) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Disodium EDTA, Xanthan Gum, Isoceteth-10, Isoceteth-25, Potassium Sorbate, Arginine, Citric Acid, Ethylhexylglycerin, Moringa Oleifera Seed Oil, Calophyllum Inophyllum Seed Oil, Zinc Oxide (CI 77947), Tocopherol

PURPOSE

OTC - PURPOSE SECTION

Purpose: Sunscreen

WARNINGS

WARNINGS SECTION

Warnings: For external use only When using this product do not get into eyes, Stop use and ask a doctor if rash occurs Do not use on - deep puncture wounds - animal bites - serious burns Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep Out of Reach of Children

DESCRIPTION

DESCRIPTION SECTION

Uses: Blend onto skin following daily skincare routine for UV protection. Reapply this product before sun exposure.

Directions: Take an adequate amount of this product everyday.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809451331112GTIN-13: 8809451331112
EAN-13: 8809451331112
GTIN storage (14 digits): 08809451331112
cizar cream carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71128-010-022020-01-31C16284748780-19d75b9cf-e942-f424-e053-dadaa90a57ce424470b1-eaf5-4b67-bf23-3c07b151c32e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71128-010-01CIZAR Aqua Sun45 mL in 1 CONTAINERCREAM452
71128-010-02CIZAR Aqua Sun1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71128-010CIZAR AQUA SUN (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [TISSUEGENE,INC]2Legacy NDC, 2 package rows20181217_424470b1-eaf5-4b67-bf23-3c07b151c32e.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71128-01071128-010-01, 71128-010-02

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

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
dc368255-bd5e-4f36-bdd8-61d616581058424470b1-eaf5-4b67-bf23-3c07b151c32e2018-12-17WarningsExact identifier
spl id: dc368255-bd5e-4f36-bdd8-61d616581058
spl set id: 424470b1-eaf5-4b67-bf23-3c07b151c32e

Reported adverse events (FAERS/openFDA)#

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