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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Image of carton

TONE UP WHITE SUN 
zinc oxide, titanium dioxide, octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69894-310
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION3.60 mg  in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide2.07 mg  in 50 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate2.00 mg  in 50 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate2.00 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69894-310-0150 mL in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2015
Labeler - WOW VENTURES (688731080)
Registrant - WOW VENTURES (688731080)
Establishment
NameAddressID/FEIBusiness Operations
WOW VENTURES688731080repack(69894-310)
Establishment
NameAddressID/FEIBusiness Operations
Cosmecca Korea Co.,Ltd.688830827manufacture(69894-310)

Revised: 6/2015
Document Id: a61342ff-6a0f-4604-8e4c-143a8d574313
Set id: 85759f43-2903-48ff-939e-46f9661a1613
Version: 1
Effective Time: 20150626
 
WOW VENTURES