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

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, 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.

Description

Zinc Oxide 12%

Questions?

1-866-41-AVENE (28363)

Box 338079

Do Not Use

• on broken skin.

Active Ingredient

Zinc Oxide 12%

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

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, 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.

Questions?

1-866-41-AVENE (28363)

Box 338079

Do Not Use (Do not use)

• on broken skin.

Active Ingredient

Zinc Oxide 12%

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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