CALIFORNIA ALOE WATERPROOF SUN BLOCK- zinc oxide, titanium dioxide cream

CALIFORNIA ALOE WATERPROOF SUN BLOCK by

Drug Labeling and Warnings

CALIFORNIA ALOE WATERPROOF SUN BLOCK 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: Zinc Oxide 9.7%, Titanium Dioxide 5.95%

INACTIVE INGREDIENT

Inactive ingredients:
WATER, GLYCERIN, BUTYLENE GLYCOL, ETHYLHEXYL PALMITATE, CYCLOPENTASILOXANE, ACRYLATES COPOLYMER, NEOPENTYL GLYCOL DIHEPTANOATE, NIACINAMIDE, PROPANEDIOL, CYCLOHEXASILOXANE, POLYMETHYLSILSESQUIOXANE, CAPRYLYL METHICONE, DIMENTHICONE, CETEARYL ALCOHOL, TRICETEARETH-4 PHOSPHATE, GLYCERYL STEARATE, PEG-100 STEARATE, GLYCOL STEARATE, SILICA, PEG-2 STEARATE, POTASSIUM CETYL PHOSPHATE, SORBITAN SESQUIOLEATE, PHENOXYETHANOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, FRAGANCE(PARFUM), TROMETHAMINE, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, SEA WATER, ADENOSINE, XANTHAN GUM, IRON OXIDES(CI 774692), DISODIUM EDTA, IRON OXIDES(CI 77491), HIBISCUS ROSA-SINENSIS FLOWER/LEAF EXTRACT, TRIETHOXYCAPRYLYSILANE, MORINDA CITRIFOLIA FRUIT EXTRACT, LEUCONOSTOC/RADISH ROOTH FERMENT FILTRATE, ALOE BARBADENSIS LEAF EXTRACT, PENTYLENE GLYCOL, SODIUM BENZOATE, CITRIC ACID, 1,2-HEXANEDIOL, POLYQUATERNIUM-51

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:
UV Protection.
Long-lasting strong waterproof sunblock, resistant to water and sweat.

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 WATERPROOF SUN BLOCK 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-518
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	5.82 g  in 60 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	3.57 g  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-518-02	1 in 1 CARTON	12/01/2018
1	NDC: 51346-518-01	60 mL 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	12/01/2018

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(51346-518)