HD WATERFUL BB- titanium dioxide, zinc oxide 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: Titanium Dioxide 10.44%, Zinc Oxide 1.44%

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

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 a suitable amount to and spread evenly on your skin after all skin care.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

HD WATERFUL BB 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69894-290
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide5.22 mg  in 50 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.72 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Butylene Glycol (UNII: 3XUS85K0RA)  
Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69894-290-0150 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(69894-290)
Establishment
NameAddressID/FEIBusiness Operations
Cosmecca Korea Co.,Ltd.688830827manufacture(69894-290)

Revised: 6/2015
Document Id: 92d72973-416e-48a3-b3b6-b654ab0960bc
Set id: dc0a6232-2821-40ff-ad0e-56306706a6e2
Version: 1
Effective Time: 20150626
 
WOW VENTURES