CALIFORNIA ALOE MILD SUN BLOCK- octinoxate, titanium dioxide, avobenzone cream

CALIFORNIA ALOE MILD SUN BLOCK by

Drug Labeling and Warnings

CALIFORNIA ALOE MILD 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 Ingredient: Ethylhexyl Methoxycinnamate 7.00%, Titanium Dioxide 2.13%, Butyl Methoxydibenzoylmethane 1.50%

INACTIVE INGREDIENT

Ingredients:
Water, Cyclopentasiloxane, Glycerin, Cyclohexasiloxane, Methyl Methacrylate Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Triceteareth-4 Phosphate, Glycol Stearate, Aloe Barbadensis Leaf Juice, Glyceryl Stearate, Sorbitan Sesquioleate, PEG-100 Stearate,
PEG-2 Stearate, Silica, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tromethamine, Phenoxyethanol, Glyceryl Caprylate, Beeswax, Potassium Cetyl Phosphate, Fragrance(Parfum), Caprylyl Glycol, Dimethicone, Sea Water, Butylene Glycol, Disodium EDTA, Xanthan Gum,
Hibiscus Rosa-Sinensis Flower/Leaf Extract, Ethyl Hexanediol, Morinda Citrifolia Fruit Extract, Leuconostoc/Radish Root Ferment Filtrate, Sodium Benzoate, Pentylene Glycol, Citric Acid, 1,2-Hexanediol

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 MILD SUN BLOCK 
octinoxate, titanium dioxide, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-240
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 mg  in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.06 mg  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.75 mg  in 50 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: 51346-240-01	50 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(51346-240)