Tibena Every Day Real Sunstick Uv Spf 52

Tibena Every Day Real Sunstick Uv Spf 52
SPL v1
SPL
SPL Set ID 2ab09ad7-0295-20ac-e063-6394a90afffe
Route
TOPICAL
Published
Effective Date 2025-01-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (2 g) Avobenzone (0.6 g) Homosalate (1 g) Ethylhexyl Salicylate
Inactive Ingredients
Ethylhexyl Methoxycrylene .alpha.-tocopherol Acetate Hydroxyacetophenone Rosemary Monarda Didyma Leaf Cetyl Ethylhexanoate Ceresin Butyloctyl Salicylate Caprylyl Glycol Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Butylene Glycol Euphorbia Cerifera (candelilla) Wax C12-15 Alkyl Benzoate Silica 1,2-hexanediol Dimethicone Water Bisabolol Adenosine Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Synthetic Beeswax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-02

Description

Avobenzone 3% Ethylhexyl Salicylate 5% Homosalate 10% Octocrylene 10%

Purpose

sunscreen


Medication Information

Purpose

sunscreen

Description

Avobenzone 3% Ethylhexyl Salicylate 5% Homosalate 10% Octocrylene 10%

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 from excessive heat and 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



Avobenzone 3%

Ethylhexyl Salicylate 5%

Homosalate 10%

Octocrylene 10%

Inactive Ingredients

Dimethicone, Ceresin, Butyloctyl Salicylate, Methyl Methacrylate Crosspolymer, C12-15 Alkyl Benzoate,

Silica, Cetyl Ethylhexanoate, Euphorbia Cerifera (Candelilla) Wax, Ethylhexyl Methoxycrylene, Water,

Ozokerite, Synthetic Beeswax, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer,

Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Bisabolol, 1,2-Hexanediol, Hydroxyacetophenone,

Butylene Glycol, Tocopheryl Acetate, Adenosine, Lavandula Angustifolia Flower Extract, Monarda Didyma Leaf Extract,

Mentha Piperita Leaf Extract, Freesia Refracta Extract, Chamomilla Recutita Flower Extract, Rosmarinus Officinalis Leaf Extract,

Caprylyl Glycol

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 a 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 from excessive heat and 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)



Avobenzone 3%

Ethylhexyl Salicylate 5%

Homosalate 10%

Octocrylene 10%

Inactive Ingredients (Inactive ingredients)

Dimethicone, Ceresin, Butyloctyl Salicylate, Methyl Methacrylate Crosspolymer, C12-15 Alkyl Benzoate,

Silica, Cetyl Ethylhexanoate, Euphorbia Cerifera (Candelilla) Wax, Ethylhexyl Methoxycrylene, Water,

Ozokerite, Synthetic Beeswax, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer,

Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Bisabolol, 1,2-Hexanediol, Hydroxyacetophenone,

Butylene Glycol, Tocopheryl Acetate, Adenosine, Lavandula Angustifolia Flower Extract, Monarda Didyma Leaf Extract,

Mentha Piperita Leaf Extract, Freesia Refracta Extract, Chamomilla Recutita Flower Extract, Rosmarinus Officinalis Leaf Extract,

Caprylyl Glycol

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 a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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