EAU THERMALE AVENE MINERAL LIGHT HYDRATING SUNSCREEN SPF 50- titanium dioxide, zinc oxide lotion

Eau Thermale Avene Mineral Light Hydrating Sunscreen SPF 50 by

Drug Labeling and Warnings

Eau Thermale Avene Mineral Light Hydrating Sunscreen SPF 50 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

Titanium Dioxide 4%

Zinc Oxide 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 damage 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, Butyloctyl Salicylate, Cetyl Dimethicone, Dimethicone, C12-15 Alkyl Benzoate, Glycerin, Octyldodecyl Neopentanoate, Trimethylsiloxysilicate, Styrene/Acrylates Copolymer, Dimethicone PEG-8 Laurate, Polymethylmethacrylate, Polysorbate 60, Butylene Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Arachidyl Glucoside, Arachidyl Alcohol, Behenyl Alcohol, Lecithin, Trisiloxane, Oleic Acid, Benzyl Alcohol, Sorbitol, Xanthan Gum, Tocopheryl Acetate, Disodium EDTA, Phenoxyethanol, Ethylhexylglycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Alumina, Methicone, Beeswax, Isostearic Acid, Polyhydroxystearic Acid.

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EAU THERMALE AVENE MINERAL LIGHT HYDRATING SUNSCREEN SPF 50 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67015-0786
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	40 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
DIMETHICONE PEG-8 LAURATE (UNII: 72MF9C2A18)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
POLYSORBATE 60 (UNII: CAL22UVI4M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TRISILOXANE (UNII: 9G1ZW13R0G)
OLEIC ACID (UNII: 2UMI9U37CP)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
ALUMINUM OXIDE (UNII: LMI26O6933)
METHICONE (20 CST) (UNII: 6777U11MKT)
YELLOW WAX (UNII: 2ZA36H0S2V)
ISOSTEARIC ACID (UNII: X33R8U0062)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67015-0786-1	1 in 1 CARTON	03/06/2015
1		125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/06/2015	05/01/2020

Labeler - Pierre Fabre Dermo-Cosmetique USA, Inc. (002944788)

Registrant - Pierre Fabre Dermo-Cosmetique USA, Inc. (002944788)