CALIFORNIA ALOE POWER LASTING SUN BLOCK- octinoxate, zinc oxide, octisalate, titanium dioxide cream

CALIFORNIA ALOE POWER LASTING SUN BLOCK by

Drug Labeling and Warnings

CALIFORNIA ALOE POWER LASTING SUN BLOCK by is a Otc medication manufactured, distributed, or labeled by NATURE REPUBLIC CO., LTD., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Ethylhexyl Methoxycinnamate 7.00%, Zinc Oxide 4.90%, Ethylhexyl Salicylate 4.50%, Titanium Dioxide 2.91%

INACTIVE INGREDIENT

Inactive Ingredients:
Water, Cyclopentasiloxane, Butylene Glycol, Glycerin, Cyclohexasiloxane, Caprylyl Methicone, PEG-10 Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Magnesium Sulfate, Disteardimonium Hectorite, Aloe Barbadensis Leaf Juice, Dimethicone/Vinyl Dimethicone Crosspolymer,
Aluminum Hydroxide, Stearic Acid, Phenoxyethanol, Caprylyl Glycol, Glyceryl Caprylate, Fragrance(Parfum), Dimethicone, Hibiscus Rosa-Sinensis Flower/Leaf Extract, Morinda Citrifolia Fruit Extract, Sea Wate, Ethyl Hexanediol, Leuconostoc/Radish Root Ferment Filtrate,
Sodium Benzoate, Citric Acid, Pentylene Glycol, 1,2-Hexanediol

PURPOSE

Purpose: UV Protection

Cautions

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

How to Use

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

How to Use

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 POWER LASTING SUN BLOCK 
octinoxate, zinc oxide, octisalate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-246
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 mg  in 100 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	4.9 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 mg  in 100 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.91 mg  in 100 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: 51346-246-01	100 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
Cosmax, Inc.		689049693	manufacture(51346-246)