Label: ESSENTIAL SUNSCREEN SPF50 lotion
- NDC Code(s): 57577-571-01
- Packager: Milbar Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 29, 2024
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INGREDIENTS AND APPEARANCE
ESSENTIAL SUNSCREEN SPF50
essential sunscreen spf50 lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57577-571 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 11.508 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 8.22 g in 100 mL Inactive Ingredients Ingredient Name Strength CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) XANTHAN GUM (UNII: TTV12P4NEE) SQUALANE (UNII: GW89575KF9) ISODODECANE (UNII: A8289P68Y2) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) WATER (UNII: 059QF0KO0R) PENTYLENE GLYCOL (UNII: 50C1307PZG) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PEG-40 MONOSTEARATE (UNII: ECU18C66Q7) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC) Product Characteristics Color white (Thick Lotion) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57577-571-01 100 mL in 1 TUBE; Type 0: Not a Combination Product 07/29/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/29/2024 Labeler - Milbar Laboratories (055359970) Establishment Name Address ID/FEI Business Operations Milbar Labs, Inc. 195556790 manufacture(57577-571)
