AVENE FACE SUNSCREEN SPF 50- zinc oxide lotion

Avene Face Sunscreen SPF 50 by

Drug Labeling and Warnings

Avene Face Sunscreen SPF 50 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 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 swallowed, call a poison control center or get medical help right away.

Directions

Adults and children 6 months and older:

Apply generously 15 minutes before sun exposure Reapply: at least every 2 hours after 80 minutes of swimming or sweating immediately after towel drying Children under 6 months of age: Ask a doctor 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 value 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.

Inactive Ingredients

Water/Eau/Aqua, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Glycerin, Tridecyl Salicylate, Polyglyceryl-3 Polyricinoleate, Glyceryl Stearate, Shea Butter Ethyl Esters, Sodium Chloride, Polyester-7, Silica, Neopentyl Glycol Diheptanoate, Isoamyl Laurate, Polyglyceryl-2 Dipolyhydroxystearate, Glyceryl Dibehenate, Bisabolol, Phenylpropanol, Iron Oxides, Propanediol, Lecithin, Tribehenin, Allantoin, Caprylyl Glycol,Glyceryl Behenate, Coco-Caprylate, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Polyglyceryl-4
Diisostearate/ Polyhydroxystearate/Sebacate, Hydrogenated Lecithin, Sodium Hydroxide, Tocopherol.

Other information

Protect the product in this container from excessive heat and direct sun.

Questions?

1-866-41-AVENE (28363)

1-877-441-2011 (CAN)

Box 337120

INGREDIENTS AND APPEARANCE

AVENE FACE SUNSCREEN SPF 50 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-782
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
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
LEVOMENOL (UNII: 24WE03BX2T)
PHENYLPROPANOL (UNII: 0F897O3O4M)
ALLANTOIN (UNII: 344S277G0Z)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
COCO-CAPRYLATE (UNII: 4828G836N6)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
WATER (UNII: 059QF0KO0R)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYESTER-7 (UNII: 0841698D2F)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PROPANEDIOL (UNII: 5965N8W85T)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-782-01	1 in 1 CARTON	05/01/2024
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 Drug	M020	05/01/2024

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc. (117196928)