Avene Multi-defense Fluid Tinted

Avene Multi-defense Fluid Tinted
SPL v1
SPL
SPL Set ID 132bdf9a-c5d0-e7e5-e063-6394a90a6180
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
Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate Nylon-12 Medium-chain Triglycerides Silicon Dioxide Coco-caprylate Polyglyceryl-2 Dipolyhydroxystearate Allantoin Hydrogenated Soybean Lecithin Aluminum Hydroxide Tocopherol Rosemary Stearalkonium Hectorite Phenylpropanol Tetrasodium Glutamate Diacetate Water Propanediol Tridecyl Salicylate Jojoba Oil, Randomized Alkyl (c12-15) Benzoate Niacinamide Titanium Dioxide Ferric Oxide Red Glycerin Sodium Chloride Lecithin, Soybean Polyglyceryl-3 Diisostearate Polyglyceryl-3 Pentaricinoleate Helianthus Annuus Flowering Top Sodium Hydroxide Levomenol Methylpropanediol Caprylyl Glycol Rice Bran

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 338079

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, Caprylic/Capric Triglyceride, Jojoba Esters, C12-15 Alkyl Benzoate, Propanediol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Tridecyl Salicylate, Nylon-12, Niacinamide, Methylpropanediol, Titanium Dioxide, Iron

Oxides, 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 (Sunflower) Extract, Hydrogenated Lecithin, Aluminum Hydroxide, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tetrasodium Glutamate Diacetate, Sodium Hydroxide.

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 338079

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

Zinc Oxide 12%

Other Information

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

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Jojoba Esters, C12-15 Alkyl Benzoate, Propanediol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Tridecyl Salicylate, Nylon-12, Niacinamide, Methylpropanediol, Titanium Dioxide, Iron

Oxides, 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 (Sunflower) Extract, Hydrogenated Lecithin, Aluminum Hydroxide, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tetrasodium Glutamate Diacetate, Sodium Hydroxide.

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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