CALIFORNIA ALOE SUN- octinoxate, homosalate, zinc oxide, titanium dioxide liquid
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 5.00%, Homosalate: 5.00%, Zinc Oxide 3.88%, Titanium Dioxide 2.73%

INACTIVE INGREDIENT

Inactive ingredients: Water, Alcohol, Disiloxane, Dibutyl Adipate, Cyclopentasiloxane, Hydrogen Dimethicone, Aluminum Hydroxide, Stearic Acid, Propanediol, Dimethicone, Caprylyl Methicone, Dimethicone Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, PEG/PPG-18/18 Dimethicone, Polysilicone-15, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, 1,2-Hexanediol, Saccharide Hydrolysate, Fructooligosaccharides, Pullulan, Calcium Aluminum Borosilicate, Methyl Methacrylate Crosspolymer, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Pentylene Glycol, Sodium Chloride, Panthenol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Tocopherol, Fragrance, Polyglyceryl-2 Dipolyhydroxystearate, Nylon-12, Butylene Glycol, Opuntia Coccinellifera Fruit Extract, Aloe Barbadensis Leaf Extract, Morinda Citrifolia Extract, Ethylhexylglycerin, Hibiscus Rosa-Sinensis Extract, Leuconostoc/Radish Root Ferment Filtrate, Sea Water, Diisostearyl Malate, Iron Oxides (CI77491), Triethoxycaprylylsilane, Polyhydroxystearic Acid

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: Milky-type sunblock that leaves skin light and matte.

Directions: Shake the product 3-5 times before use. Then evenly apply an appropriate amount on areas exposed to UV rays.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

CALIFORNIA ALOE SUN
octinoxate, homosalate, zinc oxide, titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51346-502
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	2.50 g in 50 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	2.50 g in 50 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.94 g in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.36 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51346-502-02	1 in 1 CARTON	01/02/2018	12/01/2018
1	NDC:51346-502-01	50 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(51346-502)

Revised: 2/2019

Document Id: fd27ecaf-c891-484e-af5f-0988d46a1627

Set id: ac70e360-014a-4613-a885-c576d65d1d1f

Version: 2

Effective Time: 20190214

NATURE REPUBLIC CO., LTD.