Eau Thermale Avene Ultra-Light Hydrating Sunscreen SPF 50

Eau Thermale Avene Ultra-Light Hydrating Sunscreen SPF 50 by

Drug Labeling and Warnings

Eau Thermale Avene Ultra-Light Hydrating Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Pierre Fabre Dermo-Cosmetique USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EAU THERMALE AVENE ULTRA-LIGHT 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 Ultra-Light Hydrating Sunscreen SPF 50

Active ingredients

Avobenzone 3%

Homosalate 13%

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.

Warnings

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

Questions or comments?

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

Eau Thermale Avene Ultra-Light Hydrating Sunscreen Lotion SPF 50+ 

EAU THERMALE AVENE ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 67015-0787
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) HOMOSALATE130 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)  
ISODODECANE (UNII: A8289P68Y2)  
GLYCERIN (UNII: PDC6A3C0OX)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYESTER-7 (UNII: 0841698D2F)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
SORBITOL (UNII: 506T60A25R)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
DOCOSANOL (UNII: 9G1OE216XY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARETH-2 (UNII: V56DFE46J5)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
OLEIC ACID (UNII: 2UMI9U37CP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
STEARETH-100 (UNII: 4OH5W9UM87)  
YEAST MANNAN (UNII: 91R887N59P)  
P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67015-0787-11 in 1 CARTON03/06/201501/01/2020
138.5 mL in 1 BOTTLE, PLASTIC; 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)
Registrant - Pierre Fabre Dermo-Cosmetique USA, Inc. (117196928)

Revised: 9/2019
Document Id: 92353c17-ee95-3681-e053-2a95a90a8686
Set id: ac317e16-8f10-4477-8e19-22111e78bf82
Version: 3
Effective Time: 20190910
 
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