Label: TOTAL PROTRECTOR 15- octinoxate, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 66078-110-25 - Packager: MD Formulation
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated July 31, 2012
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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
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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
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INGREDIENTS AND APPEARANCE
TOTAL PROTRECTOR 15
octinoxate, zinc oxide creamProduct 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)