Eau Thermale Avene Mineral Light Mattifying Sunscreen SPF 50 Plus Lotion

Eau Thermale Avene Mineral Light Mattifying Sunscreen SPF 50 Plus by

Drug Labeling and Warnings

Eau Thermale Avene Mineral Light Mattifying Sunscreen 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]

EAU THERMALE AVENE MINERAL LIGHT MATTIFYING SUNSCREEN SPF 50 PLUS- titanium dioxide, zinc oxide lotion 
Pierre Fabre Dermo-Cosmetique USA, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Eau Thermale Avene Mineral Light Mattifying Sunscreen SPF 50 Plus Lotion

Drug Facts

Active ingredients

Titanium Dioxide 5.5%

Zinc Oxide 8%

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, C12-15 Alkyl Benzoate, Butyloctyl salicylate, Glycerin, Silica, Styrene Acrylates Copolymer, Isostearyl Isostearate, Isononyl Isononanoate, Polyester-7, Neopentyl Glycol Diheptanoate, Dicaprylyl Carbonate, Steareth-100, Phenoxyethanol, Sorbitan Isostearate, Polyglyceryl-3 Distearate, p-Anisic Acid, Glyceryl Laurate, Capryloyl Glycine, Steareth-2, Polyacrylamide, Arachidyl Alcohol, C13-14 Isoparaffin, Sorbitol, Behenyl Alcohol, Zinc Gluconate, Tocopheryl, Isostearic Acid, Polyhydroxystearic Acid, Alumina, Methicone, Ethylhexylglycerin, Sarcosine, Disodium EDTA, Arachidyl Glucoside, Mannan, Xanthan Gum, Cinnamomum Zeylanicum Bark Extract, Laureth-7, Lecithin, Iron Oxide, Oleic Acid.

Questions or comments?

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

Principal Display - 50 ml Carton

EAU THERMALE

Avene

HIGH PROTECTION

Broad spectrum SPF 50+

Water resistant (80 minutes)

Antioxidant

Oil control

50+ UVA/UVB

Mineral Light Mattifying Sunscreen Lotion

Face

FRAGRANCE-FREE ● OIL-FREE

For oily, acne-prone skin

PARIS

1.7 FL. OZ. (50 ml)

Eau Thermale Avene Mineral Light Mattifying Sunscreen Lotion -50ml carton
EAU THERMALE AVENE MINERAL LIGHT MATTIFYING SUNSCREEN SPF 50 PLUS 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 67015-0810
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE55 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOSTEARIC ACID (UNII: X33R8U0062)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SARCOSINE (UNII: Z711V88R5F)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
YEAST MANNAN (UNII: 91R887N59P)  
CINNAMON BARK OIL (UNII: XE54U569EC)  
LAURETH-7 (UNII: Z95S6G8201)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
FERROUS OXIDE (UNII: G7036X8B5H)  
OLEIC ACID (UNII: 2UMI9U37CP)  
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
GLYCERIN (UNII: PDC6A3C0OX)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
POLYESTER-7 (UNII: 0841698D2F)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
STEARETH-100 (UNII: 4OH5W9UM87)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
GLYCERYL LAURATE (UNII: Y98611C087)  
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
STEARETH-2 (UNII: V56DFE46J5)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
SORBITOL (UNII: 506T60A25R)  
DOCOSANOL (UNII: 9G1OE216XY)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67015-0810-11 in 1 CARTON02/01/201801/01/2020
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 67015-0810-33 mL in 1 PACKET; Type 0: Not a Combination Product02/01/201804/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/201801/01/2020
Labeler - Pierre Fabre Dermo-Cosmetique USA, Inc. (117196928)
Registrant - Pierre Fabre Dermo-Cosmetique USA, Inc. (117196928)

Revised: 9/2019
 
Pierre Fabre Dermo-Cosmetique USA, Inc.