Label: CIELE TINT AND PROTECT- zinc oxide lotion
- NDC Code(s): 83103-1819-1, 83103-1819-2
- 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 July 26, 2023
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- Ciele Tint and Protect
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INGREDIENTS AND APPEARANCE
CIELE TINT AND PROTECT
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83103-1819 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 132 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) WATER (UNII: 059QF0KO0R) NIACINAMIDE (UNII: 25X51I8RD4) PROPANEDIOL (UNII: 5965N8W85T) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) CAPRYLYL GLYCOL (UNII: 00YIU5438U) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ALLANTOIN (UNII: 344S277G0Z) DIMETHICONE (UNII: 92RU3N3Y1O) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM HYDROXIDE (UNII: 55X04QC32I) PROPYLENE CARBONATE (UNII: 8D08K3S51E) HEXYLENE GLYCOL (UNII: KEH0A3F75J) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) ISODODECANE (UNII: A8289P68Y2) ISOHEXADECANE (UNII: 918X1OUF1E) DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83103-1819-2 1 in 1 CARTON 06/02/2023 1 NDC:83103-1819-1 38 mL in 1 BOTTLE; 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 06/02/2023 Labeler - Ciele (105041170) Registrant - Nanophase Technologies Corporation (623502044) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 050383046 api manufacture(83103-1819) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 118812921 manufacture(83103-1819) , pack(83103-1819) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 623502044 api manufacture(83103-1819) , manufacture(83103-1819)