EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion 
Pierre Fabre Dermo-Cosmetique USA, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Eau Thermale Avene Hydrating Sunscreen SPF 50

Active ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

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.

For external use only


Do not use on damage or broken skin

When using this product

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

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • shake well before use
  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • 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 of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Other information

  • protect this product from excessive heat and direct sun.

Inactive ingredients

Water, Isononyl Isononanoate, Glycerin, Isododecane, Cetyl Dimethicone, Isohexadecane, Silica, Styrene/Acrylates Copolymer, Dimethicone, Polyester-7, Polyester-8, Neopentyl Glycol Diheptanoate, Ethylhexyl Methoxycrylene, Arachidyl Glucoside, Tocopheryl Acetate, Behenyl Alcohol, Arachidyl Alcohol, Sorbitan Isostearate, Polyglyceryl-3 Distearate, Steareth-100, Sorbitol, Phenoxyethanol, Ethylhexylglycerin, Xanthan Gum, Oleic Acid, Lecithin, Disodium EDTA, Sodium Polyacrylate, Steareth-2, Mannan, p-Anisic Acid.

Questions or comments?

 visit www.aveneusa.com or call toll-free 1-866-41-AVENE (28363)

image description

EAU THERMALE AVENE HYDRATING SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67015-0791
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISODODECANE (UNII: A8289P68Y2)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYESTER-7 (UNII: 0841698D2F)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DOCOSANOL (UNII: 9G1OE216XY)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
STEARETH-100 (UNII: 4OH5W9UM87)  
SORBITOL (UNII: 506T60A25R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
XANTHAN GUM (UNII: TTV12P4NEE)  
OLEIC ACID (UNII: 2UMI9U37CP)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
STEARETH-2 (UNII: V56DFE46J5)  
YEAST MANNAN (UNII: 91R887N59P)  
P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67015-0791-11 in 1 CARTON03/06/2015
1150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/06/201501/01/2020
Labeler - Pierre Fabre Dermo-Cosmetique USA, Inc. (117196928)

Revised: 9/2019
Document Id: 923580c7-e63d-4aa7-e053-2995a90a3c3b
Set id: 042cd302-03be-458f-96e9-622fb8ec9355
Version: 4
Effective Time: 20190910
 
Pierre Fabre Dermo-Cosmetique USA, Inc.