Label: ANHYDROUS SPF 30- titanium dioxide, zinc oxide cream
- NDC Code(s): 59958-200-02
- Packager: Owen Biosciences, Inc.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated April 22, 2022
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- Drug Facts
- PURPOSE
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- INDICATIONS & USAGE
- INFORMATION FOR PATIENTS
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INACTIVE INGREDIENT
Inactive Ingredients
Cyclopentasiloxane, Cyclomethicone, Dimethicone Crosspolymer, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer,
Dimethicone/Vinyl Dimethicone Crosspolymer, Melanin, Tribehenin, Calcium Behenate, Sorbitan Isostearate, Dimethiconol,
Alumina, PEG-10 Dimethicone, Methicone, Iron Oxides.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANHYDROUS SPF 30
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59958-200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 10.2 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3.7 g in 100 g Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE (UNII: NMQ347994Z) 17.5 g in 100 g TRIBEHENIN (UNII: 8OC9U7TQZ0) 1 g in 100 g FERRIC OXIDE RED (UNII: 1K09F3G675) 0.09 g in 100 g FERRIC OXIDE YELLOW (UNII: EX438O2MRT) 0.25 g in 100 g FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59958-200-02 30 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2011 Labeler - Owen Biosciences, Inc. (790003045) Registrant - Owen Biosciences, Inc. (790003045) Establishment Name Address ID/FEI Business Operations Owen Biosciences, Inc. 790003045 manufacture(59958-200)