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

Purpose

Sunscreen

Description

Zinc Oxide 12%


Medication Information

Warnings

For external use only.

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

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.

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.

Description

Zinc Oxide 12%

Questions?

1-866-41-AVENE (28363)

Box 338075

Do Not Use

• on broken skin.

Active Ingredient

Zinc Oxide 12%

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

Warnings

For external use only.

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

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.

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.

Questions?

1-866-41-AVENE (28363)

Box 338075

Do Not Use (Do not use)

• on broken skin.

Active Ingredient (Active ingredient)

Zinc Oxide 12%

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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