AVENE MULTI-DEFENSE FLUID TINTED- zinc oxide lotion 
Pierre Fabre USA Inc.

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Avene Multi-Defense Fluid Tinted

Drug Facts

Active Ingredient

Zinc Oxide 12%

Purpose

Sunscreen

Uses

• helps prevent sunburn.

• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Do not use

• on broken skin.

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• rash occurs.

Keep out of reach of children.

If swallowed, call a poison control center or get medical help right away.

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.

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Jojoba Esters, C12-15 Alkyl Benzoate, Propanediol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Tridecyl Salicylate, Nylon-12, Niacinamide, Methylpropanediol, Titanium Dioxide, Iron
Oxides, 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 (Sunflower) Extract, Hydrogenated Lecithin, Aluminum Hydroxide, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tetrasodium Glutamate Diacetate, Sodium Hydroxide.

Other Information

• Protect this product in this container from excessive heat and direct sun.

Questions?

1-866-41-AVENE (28363)

Box 338079

Box 338079

AVENE MULTI-DEFENSE FLUID TINTED 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-779
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE120 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)  
NYLON-12 (UNII: 446U8J075B)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
ALLANTOIN (UNII: 344S277G0Z)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ROSEMARY (UNII: IJ67X351P9)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
NIACINAMIDE (UNII: 25X51I8RD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
LEVOMENOL (UNII: 24WE03BX2T)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
RICE BRAN (UNII: R60QEP13IC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64760-779-011 in 1 CARTON05/01/2024
140 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/01/2024
Labeler - Pierre Fabre USA Inc. (117196928)
Registrant - Pierre Fabre USA Inc. (117196928)

Revised: 3/2024
Document Id: 132bdf9a-c5d1-e7e5-e063-6394a90a6180
Set id: 132bdf9a-c5d0-e7e5-e063-6394a90a6180
Version: 1
Effective Time: 20240308
 
Pierre Fabre USA Inc.