Label: CIELE FILTER AND PROTECT- titanium dioxide, zinc oxide powder
- NDC Code(s): 83103-1910-1, 83103-1910-2
- Packager: Ciele
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 August 16, 2023
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- Official Label (Printer Friendly)
- WL-AAI-ZT-P-1910
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INGREDIENTS AND APPEARANCE
CIELE FILTER AND PROTECT
titanium dioxide, zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83103-1910 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.125 g in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.225 g in 1 g Inactive Ingredients Ingredient Name Strength POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PROPANEDIOL (UNII: 5965N8W85T) PHYSALIS ANGULATA (UNII: W4TKW9D5GG) NIACINAMIDE (UNII: 25X51I8RD4) TOCOPHEROL (UNII: R0ZB2556P8) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) ISODECYL SALICYLATE (UNII: S7097PFP4C) DIMETHICONE (UNII: 92RU3N3Y1O) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) METHICONE (20 CST) (UNII: 6777U11MKT) ISOCETETH-10 (UNII: 1K92T9919H) OCTYLDODECANOL (UNII: 461N1O614Y) PHENYLPROPANOL (UNII: 0F897O3O4M) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83103-1910-2 1 in 1 CARTON 07/25/2023 1 NDC:83103-1910-1 10 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/25/2023 Labeler - Ciele (105041170)
