EAU THERMALE AVENE ANTIROUGEURS DAY REDNESS-RELIEF SOOTHING BROAD SPECTRUM SPF 25- octocrylene, octinoxate, titanium dioxide cream 
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.

----------

EAU THERMALE Avene Antirougeurs DAY Redness-relief Soothing Cream BROAD SPECTRUM SPF 25

Active Ingredients

OCTOCRYLENE 4%

OCTINOXATE 7.5%

TITANIUM DIOXIDE 4.5%

Purpose

Sunscreen

Uses

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

Warnings

For external use only.

Do not use on damaged or 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply 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-sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months: Ask a doctor


Inactive ingredients

WATER (AQUA) EAU, CYCOMETHICONE, GLYCERIN, ETHYLHEXYL PALMITATE, POTASSIUM CETYL PHOSPHATE, C12-15 ALKYL BENZOATE, GLYCERYL STEARATE, ALUMINA, BHT, BLUE 1 (CI 42090), BUTYLPARABEN, DEXTRAN SULFATE,  DISODIUM EDTA, ETHYLPARABEN, FRAGRANCE (PARFUM), HESPERIDIN METHYL CHALCONE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOBUTYLPARABEN, MAGNESIUM ALUMINUM SILICATE,  METHYLPARABEN, O-CYMEN-5-OL, PHENOXYETHANOL, POLYSORBATE 60, PROPYLPARABEN, RUSCUS ACULEATUS ROOT EXTRACT (RUSCUS ACULEATUS), SQUALANE, STEARIC ACID, TRIBEHENIN, XANTHAN GUM.

Other information

protect this product from excessive heat and direct sunlight.

Questions

1-866-41-AVENE (USA) / 1-877-441-2011 (CAN)

www.aveneusa.com

Principal Display Panel - 40 ml Carton

EAU THERMALE

Avene

Antirougeurs

DAY

Redness-relief

soothing cream

BROAD SPECTRUM SPF 25

DIN 02273594

For sensitive skin

HYPOALLERGENIQUE•NON COMEDOGENE

PARIS

40ml  e/1.35 FL.OZ

EAU THERMALE Avene Antirougeurs DAY Redness-relief soothing Cream Carton Labe






EAU THERMALE AVENE ANTIROUGEURS DAY REDNESS-RELIEF SOOTHING BROAD SPECTRUM SPF 25 
octocrylene, octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67015-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE40 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE45 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SQUALANE (UNII: GW89575KF9)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67015-0001-040 mL in 1 TUBE; Type 0: Not a Combination Product04/29/201306/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/29/201306/30/2022
Labeler - Pierre Fabre Dermo-Cosmetique USA, Inc. (117196928)

Revised: 6/2020
Document Id: a8b1a9f5-9074-e228-e053-2a95a90a0a50
Set id: 5494a677-58e7-423e-b178-93d18f65558f
Version: 4
Effective Time: 20200622
 
Pierre Fabre Dermo-Cosmetique USA, Inc.