Label: AVENE MULTI-DEFENSE FLUID- zinc oxide lotion
- NDC Code(s): 64760-778-01
- Packager: Pierre Fabre USA Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 8, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
Adults and children 6 months and older:
• Apply generously 15 minutes before sun exposure • Reapply: • at least every 2 hours • after 40 minutes of swimming or sweating • immediately after towel drying • Children under 6 months of age: Ask a doctor • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. to 2 p.m. • Wear long-sleeve shirts, pants, hats, and sunglasses.
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Inactive Ingredients
Water, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Jojoba Esters, Propanediol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Tridecyl Salicylate, Nylon-12, Niacinamide, Methylpropanediol, Silica, Glycerin, Sodium Chloride, Coco-Caprylate, Polyglyceryl-2 Dipolyhydroxystearate, Caprylyl Glycol, Bisabolol, Allantoin, Oryza Sativa (Rice) Bran Extract, Lecithin, Stearalkonium Hectorite, Polyglyceryl-3 Diisostearate, Polyglyceryl-3 Polyricinoleate, Phenylpropanol, Helianthus Annuus (Sun‑ower) Extract, Tocopherol, Rosmarinus Ofcinalis (Rosemary) Leaf Extract, Tetrasodium Glutamate Diacetate, Sodium Hydroxide.
- Other Information
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INGREDIENTS AND APPEARANCE
AVENE MULTI-DEFENSE FLUID
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64760-778 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 120 mg in 1 mL Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PROPANEDIOL (UNII: 5965N8W85T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TOCOPHEROL (UNII: R0ZB2556P8) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) NYLON-12 (UNII: 446U8J075B) NIACINAMIDE (UNII: 25X51I8RD4) METHYLPROPANEDIOL (UNII: N8F53B3R4R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALLANTOIN (UNII: 344S277G0Z) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) WATER (UNII: 059QF0KO0R) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) LEVOMENOL (UNII: 24WE03BX2T) RICE BRAN (UNII: R60QEP13IC) SOYBEAN LECITHIN (UNII: 1DI56QDM62) PHENYLPROPANOL (UNII: 0F897O3O4M) ROSEMARY (UNII: IJ67X351P9) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) SODIUM HYDROXIDE (UNII: 55X04QC32I) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) COCO-CAPRYLATE (UNII: 4828G836N6) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64760-778-01 1 in 1 CARTON 05/01/2024 1 40 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/01/2024 Labeler - Pierre Fabre USA Inc. (117196928) Registrant - Pierre Fabre USA Inc. (117196928)
