EAU THERMALE AVENE TINTED MINERAL SUNSCREEN FLUID SPF 50 PLUS- titanium dioxide, zinc oxide lotion

Eau Thermale Avene Tinted Mineral Sunscreen Fluid SPF 50 Plus by

Drug Labeling and Warnings

Eau Thermale Avene Tinted Mineral Sunscreen Fluid SPF 50 Plus by is a Otc medication manufactured, distributed, or labeled by Pierre Fabre USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Titanium Dioxide 11.42%

Zinc Oxide 14.6%

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 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

• 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, COCO-CAPRYLATE/CAPRATE, ISOPROPYL PALMITATE, ISOCETYL STEAROYL STEARATE, ISODECYL NEOPENTANOATE, ISODODECANE, ISOHEXADECANE, PTFE, TRIETHYLHEXANOIN, DICAPRYLYL ETHER, PEG-30 DIPOLYHYDROXYSTEARATE, IRON OXIDES, MICA, ALUMINA, STEARIC ACID, CAPRYLYL GLYCOL, PEG-45/DODECYL GLYCOL COPOLYMER, SILICA, BENZOIC ACID, CAPRYLIC/CAPRIC TRIGLYCERIDE, DISODIUM EDTA, DISTEARDIMONIUM HECTORITE, GLYCERYL BEHENATE, GLYCERYL DIBEHENATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, PENTAERYTHRITYL TETRA-DI-T-BUTYL, HYDROXYHYDROCINNAMATE, POLYAMIDE-3, SODIUM CHLORIDE, TITANIUM DIOXIDE, TOCOPHEROL, TOCOPHERYL GLUCOSIDE, TRIBEHENIN, TRIETHOXYCAPRYLYLSILANE.

Questions or comments?

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

Principal Display Panel - 40 mL Carton

EAU THERMALE

Avene

VERY HIGH PROTECTION

Broad spectrum SPF 50+

Water resistant (80 minutes)

Chemical filter-free

Antioxidant

SPF 50+ UVB/UVA

Tinted Mineral

Sunscreen Fluid

FRAGRANCE-FREE

For sensitive skin, intolerant skin

PARIS

1.35 FL. OZ. (40 mL)

INGREDIENTS AND APPEARANCE

EAU THERMALE AVENE TINTED MINERAL SUNSCREEN FLUID SPF 50 PLUS 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67015-0865
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	114 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	146 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISODODECANE (UNII: A8289P68Y2)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
ALUMINUM OXIDE (UNII: LMI26O6933)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERROUS OXIDE (UNII: G7036X8B5H)
MICA (UNII: V8A1AW0880)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG-45/DODECYL GLYCOL COPOLYMER (UNII: 9H0V8CHB0X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BENZOIC ACID (UNII: 8SKN0B0MIM)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67015-0865-1	1 in 1 CARTON	05/02/2019
1		40 mL in 1 BOTTLE; 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	05/02/2019	03/31/2022

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc. (117196928)