Label: GLO SKIN- titanium dioxide, zinc oxide lotion
- NDC Code(s): 60541-0391-1, 60541-0391-2
- Packager: Glo Skin Beauty
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 March 7, 2023
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INGREDIENTS AND APPEARANCE
GLO SKIN
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60541-0391 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9.7 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 19.4 mg in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERYL STEARATE SE (UNII: FCZ5MH785I) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYESTER-7 (UNII: 0841698D2F) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ALLANTOIN (UNII: 344S277G0Z) CAPRYLYL GLYCOL (UNII: 00YIU5438U) AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG) DICRATERIA ROTUNDA OIL (UNII: Z0DWU9R4GM) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ) TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO) PULLULAN (UNII: 8ZQ0AYU1TT) XANTHAN GUM (UNII: TTV12P4NEE) STEARETH-20 (UNII: L0Q8IK9E08) HEXYLENE GLYCOL (UNII: KEH0A3F75J) TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V) SODIUM ASCORBATE (UNII: S033EH8359) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) CETYL ALCOHOL (UNII: 936JST6JCN) SQUALANE (UNII: GW89575KF9) PEG-75 STEARATE (UNII: OT38R0N74H) PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4) CETETH-20 (UNII: I835H2IHHX) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) TOCOPHEROL (UNII: R0ZB2556P8) RUTTNERA LAMELLOSA OIL (UNII: 5XZ38R4SUT) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60541-0391-2 1 in 1 CARTON 04/01/2022 1 NDC:60541-0391-1 50 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 final part352 04/01/2022 Labeler - Glo Skin Beauty (011367468) Registrant - Nanophase Technologies Corporation (623502044) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 118812921 pack(60541-0391) , manufacture(60541-0391)
