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Total Protector 30

Dosage form: cream
Ingredients: Zinc Oxide 7.8g in 100g, Octinoxate 7.5g in 100g, OCTISALATE 4.0g in 100g
Labeler: MD Formulation
NDC Code: 66078-368

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.

TOTAL PROTECTOR 30 
zinc oxide,octinaxade,octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66078-368
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (Zinc Oxide) Zinc Oxide7.8 g  in 100 g
Octinoxate (Octinoxate) Octinoxate7.5 g  in 100 g
OCTISALATE (OCTISALATE) OCTISALATE4.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
ALLANTOIN 
EDETATE DISODIUM 
XANTHAN GUM 
CETYL HYDROXYETHYLCELLULOSE (350000 MW) 
METHYLPARABEN 
Diazolidinyl Urea 
Iodopropynyl Butylcarbamate 
GLYCERYL MONOSTEARATE 
Steareth-2 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
Steareth-100 
TRIACONTANYL PVP (WP-660) 
Packaging
#Item CodePackage Description
1NDC:66078-368-17288 PACKET (PACKET) 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/FEIOperations
Harmony Labs, Inc.105803274manufacture, label, pack, relabel, repack

Revised: 07/2011
Document Id: 53a19b28-930b-45b1-ac78-aba6f64f8bd7
Set id: b4174ada-bad6-4a9b-8e4a-2b51aab26e78
Version: 2
Effective Time: 20110705
 
MD Formulation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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