CALIFORNIA ALOE AQUA SUN- octinoxate, homosalate, octisalate, avobenzone gel
NATURE REPUBLIC CO., LTD.

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: Ethylhexyl Methoxycinnamate 6.00%, Homosalate 5.00%, Ethylhexyl Salicylate 4.00%, Butyl Methoxydibenzoylmethane 2.80%

INACTIVE INGREDIENT

Inactive ingredients: Water, Dibutyl Adipate, Alcohol, Propanediol, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, 1,2-Hexanediol, Cyclopentasiloxane, Saccharide Hydrolysate, Fructooligosaccharides, Pullulan, Pentylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Polymethylsilsesquioxane, Methyl Methacrylate Crosspolymer, Fragrance, Phenoxyethanol, Triethanolamine, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butylene Glycol, Aloe Barbadensis Leaf Extract, Morinda Citrifolia Extract, Ethylhexylglycerin, Hibiscus Rosa-Sinensis Extract, Leuconostoc/Radish Root Ferment Filtrate, Sea Water

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only. 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: Tightly adhering, moisturizing, and strong gel-type sun block.

Directions: Take an adequate amount of the product and thoroughly apply on the areas exposed to the UV rays.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

CALIFORNIA ALOE AQUA SUN
octinoxate, homosalate, octisalate, avobenzone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51346-501
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	3.60 g in 60 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	3.00 g in 60 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	2.40 g in 60 mL
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	1.68 g in 60 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Dibutyl Adipate (UNII: F4K100DXP3)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51346-501-02	1 in 1 CARTON	01/02/2018	12/01/2018
1	NDC:51346-501-01	60 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	01/02/2018	12/01/2018

Labeler - NATURE REPUBLIC CO., LTD. (631172020)

Registrant - NATURE REPUBLIC CO., LTD. (631172020)

Name	Address	ID/FEI	Business Operations
Establishment
COSON Co., Ltd._Osan Plant		689847210	manufacture(51346-501)

Revised: 2/2019

Document Id: 312b2337-93ab-41aa-b3a1-d2b6b2d3c4f2

Set id: f2e4f0c6-0393-4050-9c0f-828bf0750230

Version: 2

Effective Time: 20190214

NATURE REPUBLIC CO., LTD.