EAU THERMALE AVENE HYDRATING SUNSCREEN BALM SPF 50 PLUS- octinoxate, octocrylene, titanium dioxide, zinc oxide stick

Eau Thermale Avene Hydrating Sunscreen Balm SPF 50 Plus by

Drug Labeling and Warnings

Eau Thermale Avene Hydrating Sunscreen Balm SPF 50 Plus 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]

Drug Facts

Active ingredients

Octinoxate 6%

Octocrylene 6%

Titanium Dioxide 1.5%

Zinc Oxide 3%

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 damaged 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

• 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

Shea Butter Ethyl Esters, Ceresin, Butyloctyl Salicylate, Hydrogenated Polydecene, Hydrogenated Polyisobutene, Copernicia Cerifera (Carnauba) Wax, Polyethylene, Ethylhexyl Palmitate, Ethyl Macadamiate, Aluminum Starch Octenylsuccinate, Octyldodecanol, Lavandula Angustifolia (Lavender) Extract, Water, Glycerin, Silica, Kaolin, Sorbitan Sesquioleate, Hyaluronic Acid, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate

Questions or comments?

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

Principal Display Panel - 7 g Carton

EAU THERMALE

Avene

HIGH PROTECTION
HAUTE PROTECTION

Broad spectrum SPF 50+

Anti-oxidant

Water resistant

(80 minutes)

50+ UVA/UVB

Hydrating Sunscreen Balm

for sensitive areas

For sensitive skin − Peaux sensibles

PARIS

NET WT. 0.25 OZ. (7 g)

INGREDIENTS AND APPEARANCE

EAU THERMALE AVENE HYDRATING SUNSCREEN BALM SPF 50 PLUS 
octinoxate, octocrylene, titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67015-0835
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	15 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CERESIN (UNII: Q1LS2UJO3A)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
OCTYLDODECANOL (UNII: 461N1O614Y)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
KAOLIN (UNII: 24H4NWX5CO)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
HYALURONIC ACID (UNII: S270N0TRQY)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67015-0835-1	1 in 1 CARTON	02/28/2017	05/01/2020
1		7 g 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	02/28/2017	05/01/2020

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

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