CAMELLIA MULTIACTION UV SUN SERUM- titanium dioxide, octinoxate cream

Camellia Multiaction UV Sun Serum by

Drug Labeling and Warnings

Camellia Multiaction UV Sun Serum by is a Otc medication manufactured, distributed, or labeled by AMAROS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Titanium Dioxide 4.7%, Ethylhexyl Methoxycinnamate 3.5%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Cyclopentasiloxane/ Cyclohexasiloxane, Butylene Glycol, Isododecane/Disteardimonium Hectorite/ Propylene Carbonate, Caprylic /Capric Triglyceride, Cetyl PEG/PPG-10/ Dimethicone, Isonol Isononanoate, Sorbitol, Dimethicone, Arbutin, Polyglyceryl-4 Isostearate, Sorbitan Sesquioleate, Sodium Chloride, Sodium PCA, Zinc Stearate, Morus Alba Bark Extract, Silica Dimethyl Silytate, Ozokerite, Centella Asiatica Extract, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Caprylhydroxamic Acid, Allantoin, Tocopheryl Acetate, Adenosine, Disodium EDTA, CI 77492, Fragrance.

PURPOSE

Purpose: Sun Screen (UV SPF45/PA++)

WARNINGS

Warnings: 1. In case of having following symptoms after using this product, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: Keep out of reach of babies and children.

INDICATIONS AND USAGE

Indication and Usage: 1. Tighten the lid after using it. 2. Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight. 3. Use it in the morning or evening.

DOSAGE AND ADMINISTRATION

Dosage and Administration: Apply this product on washed face at least 1-3 minutes before going outside. Evenly apply an appropriate amount on face or body, allowing to serum to be absorbed into skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAMELLIA MULTIACTION UV SUN SERUM 
titanium dioxide, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60899-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.88 mg  in 40 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.4 mg  in 40 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: 60899-030-01	40 mL in 1 CARTON; Type 0: Not a Combination Product	09/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2013

Labeler - AMAROS CO., LTD. (690338801)

Registrant - AMAROS CO., LTD. (690338801)

Establishment
Name	Address	ID/FEI	Business Operations
AMAROS CO., LTD.		690338801	manufacture(60899-030)