SPL v2
SPL
SPL Set ID 2735c5c7-a4ef-33c3-e063-6294a90abf97
Route
TOPICAL
Published
Effective Date 2024-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (9 g) Avobenzone (3 g) Homosalate (6 g) Octisalate (5 g)
Inactive Ingredients
Diisopropyl Adipate C12-15 Alkyl Benzoate Ethylcellulose, Unspecified Diethylhexyl Syringylidenemalonate Meadowfoam Estolide Dibutyl Lauroyl Glutamide Caprylic/capric Triglyceride Butyloctyl Salicylate Dimethicone Crosspolymer Octyldodecanol Dicaprylyl Carbonate Caprylyl Glycol Tocopherol Isododecane Polymethylsilsesquioxane (4.5 Microns) Silicon Dioxide Isohexadecane Dibutyl Ethylhexanoyl Glutamide Himanthalia Elongata

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-18
Description

Active Ingredients Avobenzone 3%, Homosalate 6%, Octisalate 5%, Octocrylene 9%

Medication Information

Warnings and Precautions

For External use only

Do not use on damaged or broken skin

When using this product, keep out of eyes. Rinse with water to remove

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

Directions

Apply generously and evenly 15 minutes before sun exposure

Reapply:

after 40 minutes of swimming or sweating

Immediately after towel drying

at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

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: Ask a doctor

Description

Active Ingredients Avobenzone 3%, Homosalate 6%, Octisalate 5%, Octocrylene 9%

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help, or contact a poison control center right away.

Section 51727-6

Inactive Ingredients:

Isododecane, Octyldodecanol, Polymethylsilsesquioxane, Dicaprylyl Carbonate, Caprylic/Capric Triglyceride, Diisopropyl Adipate, Silica, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Isohexadecane, Dimethicone Crosspolymer, Dibutyl Lauroyl Glutamide, Silica Silylate, Dibutyl Ethylhexanoyl Glutamide, Ethylcellulose, Caprylyl Glycol, Diethylhexyl Syringylidenemalonate, Himanthalia Elongata Extract, Meadowfoam Estolide, Tocopherol

Section 51945-4

Unseen Stick SPF 40

Section 55105-1

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 55106-9

Active Ingredients

Avobenzone 3%, Homosalate 6%, Octisalate 5%, Octocrylene 9%

Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

Directions

Apply generously and evenly 15 minutes before sun exposure

Reapply:

after 40 minutes of swimming or sweating

Immediately after towel drying

at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

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: Ask a doctor

Warnings and Precautions (34071-1)

For External use only

Do not use on damaged or broken skin

When using this product, keep out of eyes. Rinse with water to remove

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help, or contact a poison control center right away.

Section 51727-6 (51727-6)

Inactive Ingredients:

Isododecane, Octyldodecanol, Polymethylsilsesquioxane, Dicaprylyl Carbonate, Caprylic/Capric Triglyceride, Diisopropyl Adipate, Silica, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Isohexadecane, Dimethicone Crosspolymer, Dibutyl Lauroyl Glutamide, Silica Silylate, Dibutyl Ethylhexanoyl Glutamide, Ethylcellulose, Caprylyl Glycol, Diethylhexyl Syringylidenemalonate, Himanthalia Elongata Extract, Meadowfoam Estolide, Tocopherol

Section 51945-4 (51945-4)

Unseen Stick SPF 40

Section 55105-1 (55105-1)

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 55106-9 (55106-9)

Active Ingredients

Avobenzone 3%, Homosalate 6%, Octisalate 5%, Octocrylene 9%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:10.819743 · Updated: 2026-03-14T23:12:20.443473