TOTAL PROTECTOR 30 - zinc oxide,octinaxade,octisalate cream 
MD Formulation

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.

----------

Sun Total Protector 30

Zinc Oxide - 7.8%
Octinoxate - 7.5%
Octisalate - 4.0%

Zinc Oxide - 7.8%  (Sunscreen)
Octinoxate - 7.5%  (Sunscreen)
Octisalate - 4.0%   (Sunscreen)

Provide the skin with maximum protection against the environmental factors that lead to premature skin aging.

sample
TOTAL PROTECTOR 30 
zinc oxide,octinaxade,octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66078-368
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide7.8 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ALLANTOIN (UNII: 344S277G0Z)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Steareth-2 (UNII: V56DFE46J5)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
Steareth-100 (UNII: 4OH5W9UM87)  
TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66078-368-17288 in 1 CASE
13.24 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/13/2001
Labeler - MD Formulation (087008363)
Registrant - Harmony Labs, Inc. (105803274)
Establishment
NameAddressID/FEIBusiness Operations
Harmony Labs, Inc.105803274manufacture, label, pack, relabel, repack

Revised: 7/2011
Document Id: 53a19b28-930b-45b1-ac78-aba6f64f8bd7
Set id: b4174ada-bad6-4a9b-8e4a-2b51aab26e78
Version: 2
Effective Time: 20110705
 
MD Formulation