Avene Cleanance Mattifying Lotion SPF 50

Avene Cleanance Mattifying SPF 30 by

Drug Labeling and Warnings

Avene Cleanance Mattifying SPF 30 by is a Otc medication manufactured, distributed, or labeled by Pierre Fabre USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AVENE CLEANANCE MATTIFYING SPF 50- zinc oxide lotion 
Pierre Fabre USA Inc.

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Avene Cleanance Mattifying Lotion SPF 50

Drug Facts

Active ingredient

Zinc oxide 10%

Purpose

Sunscreen

Uses

Helps prevent sunburn

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 swallowed, call a poison control center or get medical help right away.

Directions

Adults and children 6 months and older:

Shake well Apply generously 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating 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.

Other information

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

Inactive Ingredients

Water/Eau/Aqua, C12-15 Alkyl Benzoate, Jojoba Esters, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Caprylic/Capric Triglyceride, Propanediol, Tridecyl Salicylate, Methylheptyl Isostearate, Kaolin, Niacinamide, Methylpropanediol, Glycerin, Coco-Caprylate, Silica, Sodium Chloride, Oryza Sativa (Rice) Bran Extract, Caprylyl Glycol, Bisabolol, Allantoin, Lecithin, Helianthus Annuus
(Sunflower) Extract, Phenylpropanol, Maltodextrin, Tocopherol, Lactobacillus, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tetrasodium Glutamate Diacetate, Chlorophyllin Copper Complex, Tremella Fuciformis Sporocarp Extract, Sodium Hydroxide.

Questions?

1-877-441-2011 (CAN)
1-866-41-AVENE (28363)(USA)

Box 337110

AVENE CLEANANCE MATTIFYING SPF 50 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-785
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
RICE BRAN (UNII: R60QEP13IC)
BIFIDOBACTERIUM ANIMALIS LACTIS (UNII: 5307V7XW8I)
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)
ALLANTOIN (UNII: 344S277G0Z)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
PROPANEDIOL (UNII: 5965N8W85T)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
NIACINAMIDE (UNII: 25X51I8RD4)
COCO-CAPRYLATE (UNII: 4828G836N6)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
KAOLIN (UNII: 24H4NWX5CO)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LEVOMENOL (UNII: 24WE03BX2T)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
TOCOPHEROL (UNII: R0ZB2556P8)
ROSEMARY (UNII: IJ67X351P9)
SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)
PHENYLPROPANOL (UNII: 0F897O3O4M)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-785-01	1 in 1 CARTON	04/01/2024	04/29/2024
1		50 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	04/01/2024	04/29/2024

Labeler - Pierre Fabre USA Inc. (117196928)

Revised: 4/2024

Document Id: 174116df-a176-1a6f-e063-6294a90ad942

34390-5

Set id: 1368d55c-4e38-5cfd-e063-6294a90af5c2

Version: 3

Effective Time: 20240429