SUNBLOCK - titanium dioxide lotion 
Vienna Health and Beauty Corporation

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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Drug Facts

Active Ingredients:                        Purpose

Titanium Dioxide 8%                        Sunscreen
Octyl Methoxycinnamate 6%         Sunscreen


Other Ingredients: Purified Water (Acqua), Capryic/Capic Triglyceride, C12-15 Alkyl Benzoate, Glycerin, Cetyl Alcohol, Stearyl Alcohol, Isopropyl Myristate, Propylene Glycol, Ceteareth-6,Ceteareth-25, Dimethocone, Glyceryl Stearate, Stearic Acid, Tocopherol Acetate(Vitamin E), Alpha Bisabolol, Triethanolamine, Diazolidinyl Urea, Methylparaben, Propylparaben, Allantoin, BHT.

Vienna Health and Beauty - by Minh Le, M.D. SUNBLOCK - UVA/UVB Protection - SPF30image of carton for tub

SUNBLOCK 
titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52625-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6 g  in 80 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 80 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETEARETH-25 (UNII: 8FA93U5T67)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ALLANTOIN (UNII: 344S277G0Z)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52625-101-021 in 1 CARTON
1NDC:52625-101-0180 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/01/2010
Labeler - Vienna Health and Beauty Corporation (831463919)
Registrant - Vienna Health and Beauty Corporation (831463919)
Establishment
NameAddressID/FEIBusiness Operations
Vienna Health and Beauty Corporation831463919manufacture

Revised: 7/2010
Document Id: 30b7ef3a-0034-45f8-978b-fb32462f3080
Set id: 8886fa88-5913-4dd9-ac58-c4dd0f54b669
Version: 3
Effective Time: 20100701
 
Vienna Health and Beauty Corporation