Eau Thermale Avene Mineral Ultra-Light Hydrating Sunscreen SPF 50

Eau Thermale Avene Mineral Ultra-Light Hydrating Sunscreen SPF 50 by

Drug Labeling and Warnings

Eau Thermale Avene Mineral 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 MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50- titanium dioxide, zinc oxide 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 Mineral Ultra-Light Hydrating Sunscreen SPF 50

Active ingredients

Titanium Dioxide 4%

Zinc Oxide 6%

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, Butyloctyl Salicylate, Cetyl Dimethicone, Dimethicone, Octyldodecyl Neopentanoate, C12-15 Alkyl Benzoate, Trimethylsiloxysilicate, Styrene/Acrylates Copolymer, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone PEG-8 Laurate, Polymethylmethacrylate, Glycerin, Butylene Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Lecithin, Trisiloxane, Oleic Acid, Xanthan Gum, Sorbitol, Tocopheryl Acetate, Disodium EDTA, Phenoxyethanol, Ethylhexylglycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Alumina, Methicone, Isostearic Acid, Polyhydroxystearic Acid, Sodium Chloride

Questions or comments?

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

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

EAU THERMALE AVENE MINERAL ULTRA-LIGHT HYDRATING SUNSCREEN SPF 50 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 67015-0784
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE40 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
DIMETHICONE PEG-8 LAURATE (UNII: 72MF9C2A18)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
TRISILOXANE (UNII: 9G1ZW13R0G)  
OLEIC ACID (UNII: 2UMI9U37CP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SORBITOL (UNII: 506T60A25R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67015-0784-11 in 1 CARTON03/06/201504/01/2019
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 finalpart35203/06/201504/01/2020
Labeler - Pierre Fabre Dermo-Cosmetique USA, Inc. (117196928)
Registrant - Pierre Fabre Dermo-Cosmetique USA, Inc. (117196928)

Revised: 9/2019
 
Pierre Fabre Dermo-Cosmetique USA, Inc.