Label: INVINCIBLE SETTING POWDER SPF 45- titanium dioxide, zinc oxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 75936-105-01 - Packager: TAYLOR JAMES, LTD.
- 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 January 13, 2017
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive Ingredients Silica, Calcium Aluminum Borosilicate, Polymethyl Methacrylate, Lauroyl Lysine, Phenoxyethanol, Water (Aqua), Sodium Dehydroacetate, Ascorbyl palmitate, Ceteareth-25, Glycerin, Cetyl Alcohol, Cholesterol, Ceramide NP, Behenic Acid, Ethylhexyglycerin, Ceramide NS, Ceramide AP, Ceramide EOP, Ceramide EOS, Caprooyl Pytosphingosine, Caprooyl Sphingosine, Tocopherol, Titanium Dioxide (CI77891), Iron Oxides (CI 77491)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
INVINCIBLE SETTING POWDER SPF 45
titanium dioxide, zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-105 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 15.7 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 20 g in 100 g Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) LAUROYL LYSINE (UNII: 113171Q70B) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) ASCORBYL PALMITATE (UNII: QN83US2B0N) CETEARETH-25 (UNII: 8FA93U5T67) GLYCERIN (UNII: PDC6A3C0OX) CETYL ALCOHOL (UNII: 936JST6JCN) CHOLESTEROL (UNII: 97C5T2UQ7J) CERAMIDE NP (UNII: 4370DF050B) BEHENIC ACID (UNII: H390488X0A) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CERAMIDE NG (UNII: C04977SRJ5) Ceramide AP (UNII: F1X8L2B00J) CERAMIDE 1 (UNII: 5THT33P7X7) N-HEXANOYLSPHINGOSINE (UNII: 038753E78J) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-105-01 4.5 g in 1 PACKAGE; Type 0: Not a Combination Product 01/13/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/13/2017 Labeler - TAYLOR JAMES, LTD. (033381850) Registrant - TAYLOR JAMES, LTD. (033381850) Establishment Name Address ID/FEI Business Operations Kolmar Laboratories, Inc. 001535103 manufacture(75936-105)