Tibena Everything Multi Cushion Spf50

Tibena Everything Multi Cushion Spf50
SPL v1
SPL
SPL Set ID 421eda8f-62b2-30fb-e063-6394a90a4947
Route
TOPICAL
Published
Effective Date 2025-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (1.943 g) Homosalate (1.2 g)
Inactive Ingredients
Disteardimonium Hectorite Asiaticoside Madecassic Acid Asiatic Acid Adenosine Edetate Disodium Anhydrous Butyloctyl Salicylate Niacinamide Water Triethoxycaprylylsilane Ferric Oxide Red Alpha-tocopherol Acetate Caprylyl Glycol Ferrosoferric Oxide Centella Asiatica Triterpenoids Butylene Glycol Sorbitan Isostearate Glycerin Isododecane Ferric Oxide Yellow Magnesium Sulfate .beta.-citronellol, (r)- Madecassoside Limonene, (+)- Hyaluronate Sodium Linalool, (+/-)- Aluminum Hydroxide Trisiloxane 1,2-hexanediol Cetyl Ethylhexanoate Ethylhexyl Methoxycrylene Cocoyl Caprylocaprate Polyglyceryl-4 Oleate Hydroxyacetophenone Monarda Didyma Leaf Rosemary

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-27

Description

Homosalate 8 % Titanium Dioxide 12.95 %

Purpose

sunscreen


Medication Information

Purpose

sunscreen

Description

Homosalate 8 % Titanium Dioxide 12.95 %

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.

Section 51945-4

Warnings

For external use only

Directions

■ Apply liberally 15 minutes before sun exposure.

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. – 2 p.m.

·wear long-sleeved shirts, pants, hats, and sunglasses

■ Children under 6 months of age: Ask a doctor

■ Reapply at least every 2 hours.

■ Use a water-resistant sunscreen if swimming or sweating.

Do Not Use

· on damaged skin or broken skin.

Other Information

■ Protect the product in this container form excessive heat or direct sun. ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Active Ingredients

Homosalate 8 %

Titanium Dioxide 12.95 %

Inactive Ingredients

Water, Butyloctyl Salicylate, Cetyl Ethylhexanoate, Glycerin, Isododecane, Butylene Glycol, Coco-Caprylate/Caprate, Trimethylsiloxysilicate, Ethylhexyl Methoxycrylene, Polyglyceryl-3 Polyricinoleate, Niacinamide, Iron Oxide Yellow, Disteardimonium Hectorite, Magnesium Sulfate, Triethoxycaprylylsilane, Polyglyceryl-4 Oleate, Sorbitan Isostearate, Aluminum Hydroxide, Trisiloxane, 1,2-Hexanediol, Tocopheryl Acetate, Fragrance, Hydroxyacetophenone, Linalool, Adenosine, Limonene, Citronellol, Disodium EDTA, Centella Asiatica Extract, Sodium Hyaluronate, Monarda Didyma Leaf Extract, Rosmarinus Officinalis Leaf Extract, Chamomilla Recutita Flower Extract, Asiaticoside, Caprylyl Glycol, Madecassoside, Madecassic Acid, Asiatic Acid, Iron Oxide Black, Iron Oxide Red

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, get medical help or contact Poison Control Center 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.

Section 51945-4 (51945-4)

Purpose

sunscreen

Warnings

For external use only

Directions

■ Apply liberally 15 minutes before sun exposure.

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. – 2 p.m.

·wear long-sleeved shirts, pants, hats, and sunglasses

■ Children under 6 months of age: Ask a doctor

■ Reapply at least every 2 hours.

■ Use a water-resistant sunscreen if swimming or sweating.

Do Not Use (Do not use)

· on damaged skin or broken skin.

Other Information (Other information)

■ Protect the product in this container form excessive heat or direct sun. ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Active Ingredients (Active ingredients)

Homosalate 8 %

Titanium Dioxide 12.95 %

Inactive Ingredients (Inactive ingredients)

Water, Butyloctyl Salicylate, Cetyl Ethylhexanoate, Glycerin, Isododecane, Butylene Glycol, Coco-Caprylate/Caprate, Trimethylsiloxysilicate, Ethylhexyl Methoxycrylene, Polyglyceryl-3 Polyricinoleate, Niacinamide, Iron Oxide Yellow, Disteardimonium Hectorite, Magnesium Sulfate, Triethoxycaprylylsilane, Polyglyceryl-4 Oleate, Sorbitan Isostearate, Aluminum Hydroxide, Trisiloxane, 1,2-Hexanediol, Tocopheryl Acetate, Fragrance, Hydroxyacetophenone, Linalool, Adenosine, Limonene, Citronellol, Disodium EDTA, Centella Asiatica Extract, Sodium Hyaluronate, Monarda Didyma Leaf Extract, Rosmarinus Officinalis Leaf Extract, Chamomilla Recutita Flower Extract, Asiaticoside, Caprylyl Glycol, Madecassoside, Madecassic Acid, Asiatic Acid, Iron Oxide Black, Iron Oxide Red

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, get medical help or contact Poison Control Center right away.


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Raw Label Data

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