Label: BABY BARE REPUBLIC MINERAL SUNSCREEN- zinc oxide lotion
- NDC Code(s): 79753-007-01
- Packager: COOLA, LLC
- 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 March 7, 2023
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- Baby Bare Republic Mineral Sunscreen
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INGREDIENTS AND APPEARANCE
BABY BARE REPUBLIC MINERAL SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 12 mg in 1 mL Inactive Ingredients Ingredient Name Strength SQUALANE (UNII: GW89575KF9) PROPANEDIOL (UNII: 5965N8W85T) WATER (UNII: 059QF0KO0R) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) .ALPHA.-BISABOLOL, (-)-EPI- (UNII: 37VB7WIC8L) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) ALLANTOIN (UNII: 344S277G0Z) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYESTER-7 (UNII: 0841698D2F) GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ISODECYL SALICYLATE (UNII: S7097PFP4C) OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT) ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) ISOSTEARIC ACID (UNII: X33R8U0062) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) ISOPROPYL ALCOHOL (UNII: ND2M416302) TRIBEHENIN (UNII: 8OC9U7TQZ0) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-007-01 100 mL in 1 TUBE; Type 0: Not a Combination Product 10/26/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/26/2020 Labeler - COOLA, LLC (956990290) Registrant - Nanophase Technologies Cirporation (623502044) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 118812921 manufacture(79753-007) , pack(79753-007)
