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, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, TOCOPHERYL ACETATE, DIBUTYL ETHYLHEXANOYL GLUTAMIDE, ECHIUM PLANTAGINEUM SEED OIL, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, ALOE BARBADENSIS LEAF EXTRACT, MORINDA CITRIFOLIA EXTRACT, HIBISCUS ROSA-SINENSIS FLOWER/LEAF EXTRACT, BISABOLOL, HYDROXYACETOPHENONE, SEA WATER, WATER, BUTYLENE GLYCOL, FRAGRANCE, PHENOXYETHANOL

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:
For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children. Replace the cap after use.

DESCRIPTION

Uses:
Brightening, Wrinkle-Improvement, UV Protection.
The matte sun stick protects the skin from strong UV rays as it softly applies on the skin.

Directions: 

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

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: 51346-516
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.98 g  in 22 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.54 g  in 22 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.99 g  in 22 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: 51346-516-02	1 in 1 CARTON	01/02/2018
1	NDC: 51346-516-01	22 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(51346-516)