Label: OURSELF MINERAL SUNSCREEN- zinc oxide lotion
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NDC Code(s):
82325-4482-1,
82325-4482-2,
82325-4482-3,
82325-4482-4, view more82325-4482-5, 82325-4482-6, 82325-4482-7
- Packager: GLO PHARMA
- 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 25, 2023
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- Official Label (Printer Friendly)
- Ourself Mineral Sunscreen
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INGREDIENTS AND APPEARANCE
OURSELF MINERAL SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82325-4482 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 TOCOPHEROL (UNII: R0ZB2556P8) ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M) METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF) NYLON-12 (UNII: 446U8J075B) PHENYLPROPANOL (UNII: 0F897O3O4M) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) PROPANEDIOL (UNII: 5965N8W85T) WATER (UNII: 059QF0KO0R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) ALLANTOIN (UNII: 344S277G0Z) SODIUM CHLORIDE (UNII: 451W47IQ8X) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG) SODIUM HYDROXIDE (UNII: 55X04QC32I) PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C) ORYZA SATIVA WHOLE (UNII: 84IVV0906Z) COCO-CAPRYLATE (UNII: 4828G836N6) .BETA.-BISABOLOL (UNII: LP618AV2EA) NIACINAMIDE (UNII: 25X51I8RD4) METHYLPROPANEDIOL (UNII: N8F53B3R4R) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82325-4482-2 1 in 1 CARTON 10/22/2021 1 NDC:82325-4482-1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:82325-4482-3 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/22/2021 3 NDC:82325-4482-5 1 in 1 CARTON 04/22/2022 3 NDC:82325-4482-4 7 mL in 1 TUBE; Type 0: Not a Combination Product 4 NDC:82325-4482-7 1 in 1 CARTON 07/25/2023 4 NDC:82325-4482-6 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 not final part352 10/22/2021 Labeler - GLO PHARMA (117648807) Registrant - Nanophase Technologies Cirporation (623502044) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 118812921 manufacture(82325-4482) , pack(82325-4482)
