OURSELF MINERAL SUNSCREEN- zinc oxide lotion

Ourself Mineral Sunscreen by

Drug Labeling and Warnings

Ourself Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by GLO PHARMA, Nanophase Technologies Cirporation, Nanophase Technologies Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Ourself Mineral Sunscreen

INGREDIENTS AND APPEARANCE

OURSELF MINERAL SUNSCREEN 
zinc oxide lotion

Product 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)