Avene Multi-defense Fluid

Avene Multi-defense Fluid
SPL v1
SPL
SPL Set ID 1329e56d-1e74-4bcc-e063-6394a90ae0c3
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 Propanediol Caprylyl Glycol Tocopherol Tetrasodium Glutamate Diacetate Tridecyl Salicylate Nylon-12 Niacinamide Methylpropanediol Silicon Dioxide Allantoin Stearalkonium Hectorite Water Jojoba Oil, Randomized Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate Glycerin Sodium Chloride Polyglyceryl-2 Dipolyhydroxystearate Levomenol Rice Bran Soybean Lecithin Phenylpropanol Rosemary Polyglyceryl-3 Diisostearate Sodium Hydroxide Alkyl (c12-15) Benzoate Coco-caprylate Polyglyceryl-3 Pentaricinoleate Helianthus Annuus Flowering Top

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 338075

Directions

Adults and children 6 months and older:

• Apply generously 15 minutes before sun exposure • Reapply: • at least every 2 hours • after 40 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)

Active Ingredient

Zinc Oxide 12%

Other Information

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

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Jojoba Esters, Propanediol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Tridecyl Salicylate, Nylon-12, Niacinamide, Methylpropanediol, Silica, Glycerin, Sodium Chloride, Coco-Caprylate, Polyglyceryl-2 Dipolyhydroxystearate, Caprylyl Glycol, Bisabolol, Allantoin, Oryza Sativa (Rice) Bran Extract, Lecithin, Stearalkonium Hectorite, Polyglyceryl-3 Diisostearate, Polyglyceryl-3 Polyricinoleate, Phenylpropanol, Helianthus Annuus (Sun‑ower) Extract, Tocopherol, Rosmarinus Of­cinalis (Rosemary) Leaf Extract, Tetrasodium Glutamate Diacetate, Sodium Hydroxide.

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 338075

Directions

Adults and children 6 months and older:

• Apply generously 15 minutes before sun exposure • Reapply: • at least every 2 hours • after 40 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)

Active Ingredient (Active ingredient)

Zinc Oxide 12%

Other Information

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

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Jojoba Esters, Propanediol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Tridecyl Salicylate, Nylon-12, Niacinamide, Methylpropanediol, Silica, Glycerin, Sodium Chloride, Coco-Caprylate, Polyglyceryl-2 Dipolyhydroxystearate, Caprylyl Glycol, Bisabolol, Allantoin, Oryza Sativa (Rice) Bran Extract, Lecithin, Stearalkonium Hectorite, Polyglyceryl-3 Diisostearate, Polyglyceryl-3 Polyricinoleate, Phenylpropanol, Helianthus Annuus (Sun‑ower) Extract, Tocopherol, Rosmarinus Of­cinalis (Rosemary) Leaf Extract, Tetrasodium Glutamate Diacetate, Sodium Hydroxide.

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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