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

Avene Solaire UV Mineral Sunscreen by

Drug Labeling and Warnings

Avene Solaire UV 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

Purpose

Sunscreen

Active Ingredient

Zinc Oxide 12%

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 80 minutes of swimming or sweating.

Immediately after towel dry.

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 of skin cancer and early skin gaining. 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

AVÈNE THERMAL SPRING WATER, C12-15 ALKYL BENZOATE,
CAPRYLIC/CAPRIC TRIGLYCERIDE, PROPANEDIOL, JOJOBA ESTERS,
TRIDECYL SALICYLATE, METHYLHEPTYL ISOSTEARATE, POLYGLYCERYL-4
DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, NYLON-12,
NIACINAMIDE, METHYLPROPANEDIOL, COCO-CAPRYLATE, SILICA,
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, 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+

Broad Spectrum

Solaire UV

Mineral Multi-Defense

Sunscreen Fluid

Fragrance-Free

Oil-Free

40-Minute Water Resistance

Sheer, Non-Whitening

For Sensitive Skin

50 ml/1.7 FL. OZ.

INGREDIENTS AND APPEARANCE

AVENE SOLAIRE UV MINERAL SUNSCREEN  SPF 50 PLUS
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-724
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
ROSEMARY OIL (UNII: 8LGU7VM393)
LEVOMENOL (UNII: 24WE03BX2T)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
NIACINAMIDE (UNII: 25X51I8RD4)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISOSTEARIC ACID (UNII: X33R8U0062)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
JOJOBA OIL (UNII: 724GKU717M)
METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF)
NYLON-12 (UNII: 446U8J075B)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
COCO-CAPRYLATE (UNII: 4828G836N6)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALLANTOIN (UNII: 344S277G0Z)
RICE BRAN OIL (UNII: LZO6K1506A)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
PHENYLPROPANOL (UNII: 0F897O3O4M)
HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-724-01	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)