TOTAL PROTRECTOR 15- octinoxate, zinc oxide cream

Total Protrector 15 by

Drug Labeling and Warnings

Total Protrector 15 by is a Otc medication manufactured, distributed, or labeled by MD Formulation, Ei Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octinoxate - 7.5%             Sunscreen
Zink Oxide - 4.9%             Sunscreen

INDICATIONS & USAGE

When using this product do not use in or near the eyes.If product gets into eyes, rlnse thoroughly with water.

WARNINGS

Warnings: For external use only.

STOP USE

Stop use and ask a doctor if Irritation or rash appears and lasls.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed , get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions: Children under 2 years of age should use sunscreen products with a minimum SPF of 4.
Adult and children 6 months and over: apply liberally 15 minutes before sun or water exposure; reapply after swimming or excessive sweating or anytime after towel drying . Children under 6 months ask a doctor.

SPL UNCLASSIFIED SECTION

Other information store at 20.25C (68-770 F)
Sun Alert: The sun causes sun damage. Regular use of sunscreens over the years may reduce the chance of skIn damage, some types of skin cancer, and other harmful effects due to the sun.

INACTIVE INGREDIENT

Inactive ingredients: Water (Aqua), Glyceryl Stearate, C12-15 Alkyl Benzoate, GlycerIn, Steareth-2, Steareth-100, Tricontanyl PVP, PEG-100 Stearate, Tocopheryl Acetate, Allantoin, Xanthan Gum, Cetyl Hydroxyelhylcellulose, Dimethicone, Disodium EDTA, Diazolidinyl Urea, lodopropynyl Butylcarbamate, Methylparaben. Propylparaben.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOTAL PROTRECTOR 15  
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66078-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	4.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
ALLANTOIN (UNII: 344S277G0Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
STEARETH-2 (UNII: V56DFE46J5)
PEG-100 STEARATE (UNII: YD01N1999R)
STEARETH-100 (UNII: 4OH5W9UM87)
TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66078-110-25	42 in 1 CASE
1		1 in 1 CARTON
1		78 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/08/2007

Labeler - MD Formulation (087008363)

Registrant - Ei Inc (105803274)

Establishment
Name	Address	ID/FEI	Business Operations
Ei Inc		105803274	manufacture(66078-110) , pack(66078-110) , label(66078-110)