SPL v1
SPL
SPL Set ID 4907eb9c-3978-27ed-e063-6394a90a9f66
Route
TOPICAL
Published
Effective Date 2026-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (1.5 g) Octinoxate (3.5 g) Octocrylene (5 g) Homosalate (2.5 g) Octisalate
Inactive Ingredients
Polyglyceryl-6 Behenate Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) .alpha.-tocopherol Acetate Adenosine Centella Asiatica Triterpenoids Monarda Didyma Leaf Rosemary Asiaticoside Madecassic Acid Ethylhexyl Methoxycrylene Niacinamide Docosanol Polysorbate 60 Polyglyceryl-6 Stearate Sodium Polyacryloyldimethyl Taurate Butyloctyl Salicylate Butylene Glycol 1,2-hexanediol Panthenol Water Silicon Dioxide Sorbitan Sesquioleate Hydroxyacetophenone Madecassoside

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-12

Description

avobenzone 3.0% Homosalate 10.0% Octinoxate 7.0% Octocrylene 10.0% Octisalate 5.0%

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

avobenzone 3.0% Homosalate 10.0% Octinoxate 7.0% Octocrylene 10.0% Octisalate 5.0%

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

Stop Use

and ask a doctor if • rash occurs

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

Keep Out of Reach

of children If swallowed, get medical help or contact a Poison Control Center right away.

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 3.0%

Homosalate 10.0%

Octinoxate 7.0%

Octocrylene 10.0%

Octisalate 5.0%

Inactive Ingredients

Water, Butyloctyl Salicylate, Butylene Glycol, Polyglyceryl-6 Stearate, Ethylhexyl Methoxycrylene, Silica, Niacinamide, Poly C10-30 Alkyl Acrylate, Sorbitan Sesquioleate, Behenyl Alcohol, 1,2-Hexanediol, Hydroxyacetophenone, Polysorbate 60, Sodium Polyacryloyldimethyl Taurate, Polyglyceryl-6 Behenate, Tocopheryl Acetate, Panthenol, Polyacrylate Crosspolymer-6, Sphingomonas Ferment Extract, Disodium EDTA, Adenosine, Centella Asiatica Extract, Monarda Didyma Leaf Extract, Mentha Piperita Leaf Extract, Lavandula Angustifolia Flower Extract, Freesia Refracta Extract, Rosmarinus Officinalis Leaf Extract, Chamomilla Recutita Flower Extract, Asiaticoside, Madecassoside, Madecassic Acid, Asiatic Acid

When Using This Product

• keep out of eyes. Rinse with water to remove.


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

Stop Use (Stop use)

and ask a doctor if • rash occurs

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

Keep Out of Reach (Keep out of reach)

of children If swallowed, get medical help or contact a Poison Control Center right away.

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 3.0%

Homosalate 10.0%

Octinoxate 7.0%

Octocrylene 10.0%

Octisalate 5.0%

Inactive Ingredients (Inactive ingredients)

Water, Butyloctyl Salicylate, Butylene Glycol, Polyglyceryl-6 Stearate, Ethylhexyl Methoxycrylene, Silica, Niacinamide, Poly C10-30 Alkyl Acrylate, Sorbitan Sesquioleate, Behenyl Alcohol, 1,2-Hexanediol, Hydroxyacetophenone, Polysorbate 60, Sodium Polyacryloyldimethyl Taurate, Polyglyceryl-6 Behenate, Tocopheryl Acetate, Panthenol, Polyacrylate Crosspolymer-6, Sphingomonas Ferment Extract, Disodium EDTA, Adenosine, Centella Asiatica Extract, Monarda Didyma Leaf Extract, Mentha Piperita Leaf Extract, Lavandula Angustifolia Flower Extract, Freesia Refracta Extract, Rosmarinus Officinalis Leaf Extract, Chamomilla Recutita Flower Extract, Asiaticoside, Madecassoside, Madecassic Acid, Asiatic Acid

When Using This Product (When using this product)

• keep out of eyes. Rinse with water to remove.


Advanced Ingredient Data


Raw Label Data

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