CALIFORNIA ALOE AQUA SUN- octocrylene, octinoxate, octisalate stick

CALIFORNIA ALOE AQUA SUN by

Drug Labeling and Warnings

CALIFORNIA ALOE AQUA SUN by is a Otc medication manufactured, distributed, or labeled by NATURE REPUBLIC CO., LTD., Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

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

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

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

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