AVENE HYDRANCE MOISTURIZING SPF 30- zinc oxide lotion

Avene Hydrance Moisturizing SPF 30 by

Drug Labeling and Warnings

Avene Hydrance Moisturizing 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]

Drug Facts

Active ingredient

Zinc oxide 10%

Purpose

Sunscreen

Uses

helps prevent sunburn.

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 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.

Inactive Ingredients

Water, Tridecyl Salicylate, Caprylic/Capric Triglyceride, Shea Butter Ethyl Esters, Propanediol, Coco-Caprylate, C13-15 Alkane, Glycerin, Undecane, Methylpropanediol, Polyglyceryl-3 Polyricinoleate, Pyrus Malus (Apple) Fruit Extract, Sodium Chloride, Disteardimonium Hectorite, Isoamyl Laurate, Silica, Tridecane, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Caprylyl Glycol, Bisabolol, Allantoin, Lecithin, Aloe Barbadensis Leaf Juice Powder, Phenylpropanol, Tetrasodium Glutamate Diacetate, Tocopherol, Sodium Hydroxide.

Other Information

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

Questions?

1-866-41-AVENE (28363)

1-877-441-2011 (CAN)

Box 336505

INGREDIENTS AND APPEARANCE

AVENE HYDRANCE MOISTURIZING SPF 30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-783
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
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
COCO-CAPRYLATE (UNII: 4828G836N6)
C13-15 ALKANE (UNII: 114P5I43UJ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
TOCOPHEROL (UNII: R0ZB2556P8)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)
PROPANEDIOL (UNII: 5965N8W85T)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
APPLE (UNII: B423VGH5S9)
ALLANTOIN (UNII: 344S277G0Z)
PHENYLPROPANOL (UNII: 0F897O3O4M)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TRIDECANE (UNII: A3LZF0L939)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
UNDECANE (UNII: JV0QT00NUE)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
LEVOMENOL (UNII: 24WE03BX2T)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-783-01	1 in 1 CARTON	04/01/2024
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	04/01/2024

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc. (117196928)