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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)
Available from:
Tissuegene,inc
INN (International Name):
Homosalate
Composition:
Homosalate 4.27 g in 45 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Sunscreen
Authorization status:
OTC monograph not final
Authorization number:
71128-010-01, 71128-010-02

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

T is s uegene,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.

----------

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

CIZAR AQUA SUN

homosalate, octocrylene, octisalate, avobenzone cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:71128 -0 10

Route of Administration

TOPICAL

T issue ge ne ,inc

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Ho mo sa la te (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

Ho mo sa la te

4.27 g in 45 mL

O cto crylene (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

O c to c ryle ne

2.25 g in 45 mL

O ctisa la te (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

O c tisa la te

2.0 2 g in 45 mL

Avo benzo ne (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

Avo be nz o ne

1.35 g in 45 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Butylene Glyco l (UNII: 3XUS8 5K0 RA)

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:71128 -0 10 -

1 in 1 CARTON

0 6 /0 1/20 17

1

NDC:71128 -0 10 -0 1

45 mL in 1 CONTAINER; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 6 /0 1/20 17

Labeler -

T issuegene,inc (694860183)

Registrant -

T issuegene,inc (694860183)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Co smax, Inc.

6 8 9 0 49 6 9 3

ma nufa c ture (71128 -0 10 )

Revised: 12/2018

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