CALIFORNIA ALOE AQUA SUN- octocrylene, octinoxate, octisalate stick
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: OCTOCRYLENE 9.00%, ETHYLHEXYL METHOXYCINNAMATE 7.00%, ETHYLHEXYL SALICYLATE 4.50%

INACTIVE INGREDIENT

Inactive ingredients: OCTYLDODECANOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, DICAPRYLYL CARBONATE, DIBUTYL LAUROYL GLUTAMIDE, SILICA SILYLATE, DIBUTYL ETHYLHEXANOYL GLUTAMIDE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, TOCOPHERYL ACETATE, FRAGRANCE, BISABOLOL,HYDROXYACETOPHENONE, ECHIUM PLANTAGINEUM SEED OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, WATER, SEA WATER, BUTYLENE GLYCOL, TOCOPHEROL, PHENOXYETHANOL, ALOE BARBADENSIS LEAF EXTRACT, HIBISCUS ROSA-SINENSIS FLOWER/LEAF EXTRACT, MORINDA CITRIFOLIA EXTRACT, PENTYLENE GLYCOL, CAPRYLYL GLYCOL, 1,2-HEXANEDIOL, ETHYLHEXYLGLYCERIN

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: The convenient sun stick creates smooth and clear UV protection layer over skin.

Directions: Use at the last stage of your skincare routine. Turn the dial to expose the content for use, apply an appropriate amount all over the face, and lightly spread inward to outward. Pat lightly when applying over made-up face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

CALIFORNIA ALOE AQUA SUN
octocrylene, octinoxate, octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51346-500
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.35 g in 15 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.05 g in 15 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.67 g in 15 g

Ingredient Name	Strength
Inactive Ingredients
OCTYLDODECANOL (UNII: 461N1O614Y)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51346-500-02	1 in 1 CARTON	01/02/2018	12/30/2018
1	NDC:51346-500-01	15 g 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	12/30/2018

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(51346-500)

Revised: 7/2021

Document Id: 7fbe5edb-beeb-439b-9f17-dc8af9e84b47

Set id: 44d87cad-2d59-451a-9853-ba3809b80a29

Version: 2

Effective Time: 20210713

NATURE REPUBLIC CO., LTD.