TONE UP WHITE SUN- zinc oxide, titanium dioxide, octinoxate, octisalate cream

TONE UP WHITE SUN by

Drug Labeling and Warnings

TONE UP WHITE SUN by is a Otc medication manufactured, distributed, or labeled by WOW VENTURES, Cosmecca Korea Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Zinc Oxide 7.20%, Titanium Dioxide 4.15%, Ethylhexyl Methoxycinnamate 4.00%, Ethylhexyl Salicylate 4.00%

INACTIVE INGREDIENT

Inactive Ingredients: Chamaecyparis Obtusa Water, Cyclopentasiloxane, Silica, Caprylic/Capric Triglyceride, Butylene Glycol, Alcohol Denat., PEG-10 Methyl Ether Dimethicone, Isopropyl Palmitate, C12-15 Alkyl Benzoate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Caprylyl Methicone, Dipropylene Glycol, Niacinamide, Sodium Chloride, Quaternium-18 Bentonite, PEG-10 Dimethicone, Stearalkonium Hectorite, Aluminum Hydroxide, Sorbitan Sesquioleate, Sorbitan Olivate, Stearic Acid, Polyhydroxystearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Phenoxyethanol, Dimethicone, Hydrogen Dimethicone, Fragrance, Water, Propylene Carbonate, Ethylhexyl Palmitate, Lecithin, Tocopheryl Acetate, Isostearic Acid, Sodium Benzoate, Polyglyceryl-3 Polyricinoleate, Disodium EDTA, Potassium sorbate, Adenosine, Prunus armeniaca (apricot) fruit extract, Melaleuca Alternifolia (Tea Tree) Leaf Water, Citrus Limon (Lemon) Fruit Extract, Portulaca Oleracea Extract, Pyrus Malus (Apple) Fruit Extract, Citrus aurantium dulcis (orange) fruit extract, Centella Asiatica Extract, Pentylene Glycol, Caprylyl Glycol, 1,2-Hexanediol, Ethylhexylglycerin

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: 1. If any of the following symptoms appear on the area where the product was applied, stop using the product immediately and consult a specialist. A. Redness, swelling, itchiness, irritation or other abnormal symptoms B. Symptoms above appear after exposure to direct sunlight 2. Do NOT use the product on an area with wound, eczema, or dermatitis 3. Storage and handling. A. Make sure to close the lid after use B. Keep away from children and babies C. Do NOT store in a place with high or low temperature and direct sunlight

DESCRIPTION

Directions & Usage: Apply liberally on face and body 15 minutes before sun exposure.

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TONE UP WHITE SUN 
zinc oxide, titanium dioxide, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69894-310
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	3.60 mg  in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.07 mg  in 50 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	2.00 mg  in 50 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	2.00 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69894-310-01	50 mL in 1 CARTON; 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	05/01/2015

Labeler - WOW VENTURES (688731080)

Registrant - WOW VENTURES (688731080)

Establishment
Name	Address	ID/FEI	Business Operations
WOW VENTURES		688731080	repack(69894-310)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmecca Korea Co.,Ltd.		688830827	manufacture(69894-310)