CALIFORNIA ALOE OIL FREE SUN BLOCK- octinoxate, octisalate cream

CALIFORNIA ALOE OIL FREE SUN BLOCK by

Drug Labeling and Warnings

CALIFORNIA ALOE OIL FREE SUN BLOCK by is a Otc medication manufactured, distributed, or labeled by NATURE REPUBLIC CO., LTD., Kolmar Korea Co.,LTD. Gwanjeong Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: ETHYLHEXYL METHOXYCINNAMATE 6.00%, ETHYLHEXYL SALICYLATE 3.00%

INACTIVE INGREDIENT

Ingredients:
WATER, BUTYLENE GLYCOL, CYCLOPENTASILOXANE, ALCOHOL, ISOAMYL P-METHOXYCINNAMATE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, 1,2-HEXANEDIOL, DIPROPYLENE GLYCOL, PEG/PPG-30/10 DIMETHICONE, TRIETHANOLAMINE, WATER, BUTYLENE GLYCOL, ALOE BARBADENSIS LEAF EXTRACT, 1,2-HEXANEDIOL, PENTYLENE GLYCOL, CAPRYLYL GLYCOL, FRAGRANCE, SILICA, CARBOMER, CETETH-10, PHENOXYETHANOL, ALLANTOIN, BEHENYL ALCOHOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, SEA WATER, BUTYLENE GLYCOL, WATER, PHENOXYETHANOL, MORINDA CITRIFOLIA EXTRACT, ETHYLHEXYLGLYCERIN, WATER, BUTYLENE GLYCOL, HIBISCUS ROSA-SINENSIS FLOWER/LEAF EXTRACT, PHENOXYETHANOL, TOCOPHERYL ACETATE, SODIUM HYALURONATE

PURPOSE

Purpose: UV Protection

WARNINGS

Cautions:
For external use only.
Discontinue use if signs of irritation or rashes appear.
Keep out of reach of children.
Replace the cap after use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

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

DOSAGE AND ADMINISTRATION

How to Use: 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 OIL FREE SUN BLOCK 
octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-243
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.8 mg  in 80 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.4 mg  in 80 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-243-01	80 mL in 1 CARTON; Type 0: Not a Combination Product	02/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2014

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(51346-243)