Eau Thermale Avene Complexion Correcting Shield Medium Mineral Sunscreen SPF 50 Plus

Drug Labeling and Warnings

Drug Details [pdf]

EAU THERMALE AVENE COMPLEXION CORRECTING SHIELD MEDIUM MINERAL SUNSCREEN SPF 50 PLUS- titanium dioxide, zinc oxide cream 
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 Complexion Correcting Shield Medium Mineral Sunscreen SPF 50 Plus

Drug Facts

Active ingredients

Titanium Dioxide 12.5%

Zinc Oxide 15.6%

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

• Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• 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
• May stain fabrics

Inactive ingredients

Water, Caprylic/Capric Triglyceride, Hydrogenated Polyisobutene, Dimethicone, Butyloctyl Salicylate, Isodecyl Neopentanoate, Iron Oxides, Polyhydroxystearic Acid, C12‐15 Alkyl Benzoate, Magnesium Aluminum Silicate, Polymethyl Methacrylate, Potassium Cetyl Phosphate, VP/Eicosene Copolymer, Polysorbate 20, Soyethyl Morpholinium Ethosulfate, Trimethylsiloxysilicate, Cetearyl Alcohol, Xanthan Gum, Glycerin, Phenoxyethanol, Hydrogenated Lecithin, Stearic Acid, PEG/PPG/Polybutylene Glycol‐8/5/3 Glycerin, Carbomer, Ceramide AP, Ceramide EOP, Ceramide NP, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Tocopherol, Sodium Hyaluronate, Ethylhexylglycerin, Disodium EDTA, Tocopheryl Acetate, Allantoin, Ascorbic Acid

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

HIGH PROTECTION
HAUTE PROTECTION

Broad spectrum SPF 50+

Anti-oxidant

Medium-full coverage

Blur effect

Medium

50+ UVA/UVB

Complexion Correcting

Shield

Mineral Sunscreen

FRAGRANCE-FREE OIL-FREE

For sensitive skin − Peaux sensibles

PARIS

1.35 FL. OZ. (40 mL)

EAU THERMALE AVENE COMPLEXION CORRECTING SHIELD MEDIUM MINERAL SUNSCREEN SPF 50 PLUS 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67015-0833
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	125 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	156 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SOYETHYL MORPHOLINIUM ETHOSULFATE (UNII: J8C5W5HH18)
TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
STEARIC ACID (UNII: 4ELV7Z65AP)
CARBOMER 1342 (UNII: 809Y72KV36)
CERAMIDE 6 II (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE 3 (UNII: 4370DF050B)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
TOCOPHEROL (UNII: R0ZB2556P8)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBIC ACID (UNII: PQ6CK8PD0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67015-0833-1	1 in 1 CARTON	02/28/2017
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	02/28/2017	08/01/2019

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

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

Revised: 12/2018

Document Id: 7e545df6-c3ad-e94b-e053-2a91aa0af3a6

34390-5

Set id: 06f179a8-2f71-4966-a517-99825faf9845

Version: 3

Effective Time: 20181231