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

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

Drug Labeling and Warnings

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

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

HYPOALLERGENIQUENON COMEDOGENE

PARIS

40ml  e/1.35 FL.OZ

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67015-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	45 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67015-0001-0	40 mL in 1 TUBE; Type 0: Not a Combination Product	04/29/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/29/2013

Labeler - Pierre Fabre Dermo-Cosmetique USA, Inc. (117196928)