TOTAL PROTECTOR 30- zinc oxide,octinaxade,octisalate cream

Total Protector 30 by

Drug Labeling and Warnings

Total Protector 30 by is a Otc medication manufactured, distributed, or labeled by MD Formulation, Harmony Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

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

WHEN USING

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOTAL PROTECTOR 30 
zinc oxide,octinaxade,octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66078-368
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	7.8 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66078-368-17	288 in 1 CASE
1		3.24 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/13/2001

Labeler - MD Formulation (087008363)

Registrant - Harmony Labs, Inc. (105803274)

Establishment
Name	Address	ID/FEI	Business Operations
Harmony Labs, Inc.		105803274	manufacture, label, pack, relabel, repack