Avene Face Lotion Spf 50

Avene Face Lotion Spf 50
SPL v1
SPL
SPL Set ID 132ce436-a783-2ba0-e063-6394a90a4b70
Route
TOPICAL
Published
Effective Date 2024-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (120 mg)
Inactive Ingredients
Medium-chain Triglycerides Alkyl (c12-15) Benzoate Glyceryl Monostearate Polyglyceryl-2 Dipolyhydroxystearate Levomenol Phenylpropanol Allantoin Caprylyl Glycol Glyceryl Monobehenate Coco-caprylate Tetrasodium Glutamate Diacetate Water Tridecyl Salicylate Hydrogenated Soybean Lecithin Tocopherol Sodium Chloride Polyester-7 Isoamyl Laurate Glyceryl Dibehenate Ferric Oxide Red Propanediol Lecithin, Soybean Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate Silicon Dioxide Tribehenin Sodium Hydroxide Glycerin Polyglyceryl-3 Pentaricinoleate Shea Butter Ethyl Esters Neopentyl Glycol Diheptanoate Alpha-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-01

Description

Zinc Oxide 12%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

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.

Box 337120

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.

Do Not Use

• on broken skin.

Questions?

1-866-41-AVENE (28363)

1-877-441-2011 (CAN)

Active Ingredient

Zinc Oxide 12%

Other Information

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

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.

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.


Structured Label Content

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.

Purpose

Sunscreen

Warnings

For external use only.

Box 337120

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.

Do Not Use (Do not use)

• on broken skin.

Questions?

1-866-41-AVENE (28363)

1-877-441-2011 (CAN)

Active Ingredient

Zinc Oxide 12%

Other Information (Other information)

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

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.

When Using This Product (When using this product)

• keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• rash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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