Label: TONE UP WHITE SUN- zinc oxide, titanium dioxide, octinoxate, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69894-310-01 - Packager: WOW VENTURES
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated June 26, 2015
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
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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
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TONE UP WHITE SUN
zinc oxide, titanium dioxide, octinoxate, octisalate creamProduct 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)
