TOTAL PROTRECTOR 15  - octinoxate, zinc oxide 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.

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Sun Total Protector 15

Octinoxate - 7.5%             Sunscreen
Zink Oxide - 4.9%             Sunscreen

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

Warnings: For external use only.

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

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

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.

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 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.

Label
U Carton
TOTAL PROTRECTOR 15  
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66078-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide4.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66078-110-2542 in 1 CASE
11 in 1 CARTON
178 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/08/2007
Labeler - MD Formulation (087008363)
Registrant - Ei Inc (105803274)
Establishment
NameAddressID/FEIBusiness Operations
Ei Inc105803274manufacture(66078-110) , pack(66078-110) , label(66078-110)

Revised: 7/2012
Document Id: c3fad29a-9dc1-4a2d-9bb1-3d745068b4d2
Set id: f6ecad5f-9a2d-496b-b889-fbf2230bd773
Version: 2
Effective Time: 20120731
 
MD Formulation