Label: PLUMSCREEN SPF 31- zinc oxide cream
- NDC Code(s): 80476-101-02, 80476-101-10, 80476-101-60
- Packager: Le Prunier Farms, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 28, 2024
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- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
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INACTIVE INGREDIENTS
WATER (AQUA), COCO-CAPRYLATE/CAPRATE, PRUNUS DOMESTICA SEED OIL, PRUNUS DOMESTICA EXTRACT, HYDROLYZED PRUNUS DOMESTICA FRUIT EXTRACT, GLYCERIN, CETEARYL ALCOHOL, CETEARYL OLIVATE, SORBITAN OLIVATE, PROPANEDIOL, ZONARIA TOURNEFORTII EXTRACT, SODIUM STEAROYL GLUTAMATE, SILICA, XANTHAN GUM, TETRASODIUM GLUTAMATE DIACETATE, POLYHYDROXYSTEARIC ACID, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCERYL ETHER
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INGREDIENTS AND APPEARANCE
PLUMSCREEN SPF 31
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80476-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4.7 g in 100 mL Inactive Ingredients Ingredient Name Strength COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) GLYCERIN (UNII: PDC6A3C0OX) PROPANEDIOL (UNII: 5965N8W85T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PLUM JUICE (UNII: KLB93D0YFI) WATER (UNII: 059QF0KO0R) PLUM SEED OIL (UNII: 67EIU8N086) SORBITAN OLIVATE (UNII: MDL271E3GR) CETEARYL OLIVATE (UNII: 58B69Q84JO) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) FUCUS VESICULOSUS (UNII: 535G2ABX9M) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CAPRYLYL GLYCERYL ETHER (UNII: MI97BW74XZ) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80476-101-10 1 in 1 BOX 06/21/2022 1 10 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:80476-101-60 1 in 1 BOX 06/21/2022 2 60 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:80476-101-02 2 mL in 1 PACKET; Type 0: Not a Combination Product 01/04/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/21/2022 Labeler - Le Prunier Farms, Inc. (118935302)