Label: HD WATERFUL BB- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69894-290-01 - 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, Butylene Glycol, Cyclopentasiloxane, Phenyl Trimethicone, Hydrogenated Polydecene, Dipropylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Niacinamide, Sodium Chloride, Butylene Glycol Dicaprylate/Dicaprate, Water, Bis-Diglyceryl Polyacyladipate-2, Iron Oxides (CI 77492), Polyglyceryl-4 Isostearate, Cetyl Ethylhexanoate, Methyl Hydrogenated Rosinate, Talc, Hexyl Laurate, Cetyl Dimethicone, Sorbitan Isostearate, Calcium Stearate, Dimethicone, Iron Oxides (CI 77491), Disteardimonium Hectorite, Phenoxyethanol, Glyceryl Polymethacrylate, Iron Oxides (CI 77499), Caprylyl Glycol, Glycerin, Propylene Glycol, Triethoxycaprylylsilane, Triethyl Citrate, Sorbitan Olivate, Fragrance, Hydrogenated Vegetable Oil, Alcohol, Hydrogen Dimethicone, Ethylhexylglycerin, 1,2-Hexanediol, Adenosine, Disodium EDTA, Sodium Hyaluronate, Bellis Perennis (Daisy) Flower Extract, Nelumbo Nucifera Flower Extract, Melaleuca Alternifolia (Tea Tree) Flower/Leaf/Stem Extract, Portulaca Oleracea Extract, Lilium Candidum Bulb Extract, Paeonia Lactiflora Root Extract, Centella Asiatica Extract
- 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
HD WATERFUL BB
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69894-290 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 5.22 mg in 50 mL Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.72 mg in 50 mL Inactive Ingredients Ingredient Name Strength Butylene Glycol (UNII: 3XUS85K0RA) Phenyl Trimethicone (UNII: DR0K5NOJ4R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69894-290-01 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(69894-290) Establishment Name Address ID/FEI Business Operations Cosmecca Korea Co.,Ltd. 688830827 manufacture(69894-290)
