AVENE SOLAIRE UV TINTED MINERAL SUNSCREEN SPF 50 PLUS- zinc oxide lotion

Avene Solaire UV Tinted Mineral Sunscreen by

Drug Labeling and Warnings

Avene Solaire UV Tinted Mineral Sunscreen 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 ingredient

Zinc Oxide 12%

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 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 40 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 to 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, CAPRYLIC/CAPRIC TRIGLYCERIDE, PROPANEDIOL, JOJOBA ESTERS, TRIDECYL SALICYLATE, METHYLHEPTYL ISOSTEARATE, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, NIACINAMIDE, NYLON-12, METHYLPROPANEDIOL, COCO-CAPRYLATE, IRON OXIDES, SILICA, AVENE THERMAL SPRING WATER, SODIUM CHLORIDE, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, CAPRYLYL GLYCOL, BISABOLOL, ALLANTOIN, ORYZA SATIVA (RICE) BRAN EXTRACT, LECITHIN, PHENYLPROPANOL, HELIANTHUS ANNUUS (SUNFLOWER) EXTRACT, TOCOPHEROL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, TETRASODIUM GLUTAMATE DIACETATE, ISOSTEARIC ACID, HYDROGENATED LECITHIN,1,2-HEXANEDIOL, SODIUM HYDROXIDE

Questions or comments?

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

Principal Display Panel - 50 mL Carton

EAU THERMALE

Avene

SPF 50+

UVA/UVB

Broad Spectrum SPF 50+

Solaire UV

Mineral Multi-Defense

Tinted Sunscreen Fluid

Fragrance-Free Oil-Free

Water Resistant (40-Minute)

Sheer, Natural Finish

Sensitive Skin

50 ml/1.7 FL. OZ.

Pierre Fabre

Dermo-Cosmetique

Laboratoires Dermatologiques Avène
45, place Abel-Gance
92100 Boulogne - Paris - France
Les Cauquillous - 81500 Lavaur - France
Distributed by:
Pierre Fabre USA Inc
Parsippany, NJ 07054

INGREDIENTS AND APPEARANCE

AVENE SOLAIRE UV TINTED MINERAL SUNSCREEN  SPF 50 PLUS
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-725
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
RICE BRAN OIL (UNII: LZO6K1506A)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
WATER (UNII: 059QF0KO0R)
ROSEMARY (UNII: IJ67X351P9)
LEVOMENOL (UNII: 24WE03BX2T)
METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF)
NYLON-12 (UNII: 446U8J075B)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
NIACINAMIDE (UNII: 25X51I8RD4)
ALLANTOIN (UNII: 344S277G0Z)
PHENYLPROPANOL (UNII: 0F897O3O4M)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
TOCOPHEROL (UNII: R0ZB2556P8)
ISOSTEARIC ACID (UNII: X33R8U0062)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPANEDIOL (UNII: 5965N8W85T)
JOJOBA OIL (UNII: 724GKU717M)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
COCO-CAPRYLATE (UNII: 4828G836N6)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-725-01	1 in 1 CARTON	05/17/2021
1		50 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 Drug	M020	05/17/2021	11/06/2025

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc. (117196928)