CIZAR AQUA SUN- homosalate, octocrylene, octisalate, avobenzone cream
Tissuegene,inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

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

INACTIVE INGREDIENT

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

Purpose: Sunscreen

WARNINGS

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

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 carton

CIZAR AQUA SUN
homosalate, octocrylene, octisalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71128-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	4.27 g in 45 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	2.25 g in 45 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	2.02 g in 45 mL
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	1.35 g in 45 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71128-010-02	1 in 1 CARTON	06/01/2017
1	NDC:71128-010-01	45 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	06/01/2017

Labeler - Tissuegene,inc (694860183)

Registrant - Tissuegene,inc (694860183)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmax, Inc.		689049693	manufacture(71128-010)