EAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25- octinoxate, octocrylene, titanium dioxide cream

EAU THERMALE Avene Hydrance Optimale Hydrating BROAD SPECTRUM SPF 25 by

Drug Labeling and Warnings

EAU THERMALE Avene Hydrance Optimale Hydrating 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

OCTINOXATE 7.5%

OCTOCRYLENE 8%

TITANIUM DIOXIDE 3.2%

Purpose

• Hydrance Optimale SPF 25 helps prevent sunburn.
• If used as directed with other sunscreen protection measures [see Directions], decreases the risk of skin cancer and early skin aging caused by the sun.

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 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.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.
• Children under 6 months: Ask a doctor.
• Sun Protection Measures: spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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.
    
    

Inactive Ingredients

WATER/EAU (AQUA), GLYCERIN, ETHYLHEXYL PALMITATE, CYCLOPENTASILOXANE, STEARLY ALCOHOL, POTASSIUM CETYL PHOSPHATE, CYCLOHEXASILOXANE, GLYCERYL STEARATE. ALUMINA, BENZOIC ACID, BETA-SITOSTEROL, BHT, CAPRYLIC/CAPRIC TRIGYLCERIDE, CHLORPHENESIN, DISODIUM EDTA, GLYCINE SOJA (SOYBEAN) SEED EXTRACT ( GLYCINE SOJA SEED EXTRACT), HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYDIMETHYL TAURATE COPOLYMER, PEG-32, PEG-400, PHENOXYETHANOL, PLOXAMER 188, POLYSORBATE 60, SIMETHICONE, SODIUM CHONDROITIN SULFATE, SORBITAN ISOSTEARATE, SQUALANE, TOCOPHERYL GLUCOSIDE, XANTHAN GUM.

Other Information

Protect this product from excessive heat and direct sun.

Questions or comments?

1-866-412-8363 (USA)

www.aveneusa.com /

1-877-41-2011 (CAN)

www.eau-thermal-avene.ca

EAU THERMALE Avene Hydrance Optimale Hydrating Cream BROAD SPECTRUM SPF 25 40ml Carton Label

INGREDIENTS AND APPEARANCE

EAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 
octinoxate, octocrylene, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67015-0033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	32 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ALUMINUM OXIDE (UNII: LMI26O6933)
BENZOIC ACID (UNII: 8SKN0B0MIM)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SOYBEAN (UNII: L7HT8F1ZOD)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLOXAMER 188 (UNII: LQA7B6G8JG)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SQUALANE (UNII: GW89575KF9)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67015-0033-0	1 in 1 CARTON	07/16/2018
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/16/2018

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