Label: CIZAR AQUA SUN- homosalate, octocrylene, octisalate, avobenzone cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 71128-010-01, 71128-010-02 - Packager: Tissuegene,inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 17, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
-
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
-
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
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CIZAR AQUA SUN
homosalate, octocrylene, octisalate, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71128-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/2017 Labeler - Tissuegene,inc (694860183) Registrant - Tissuegene,inc (694860183) Establishment Name Address ID/FEI Business Operations Cosmax, Inc. 689049693 manufacture(71128-010)
