SPL v3
SPL
SPL Set ID 200b61d7-6e4b-923d-e063-6294a90a42cf
Route
TOPICAL
Published
Effective Date 2020-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (0.21 g) Avobenzone (0.09 g) Octocrylene (0.06 g) Octinoxate (0.28 g)
Inactive Ingredients
Soybean Oil Sunflower Oil Mono/diglycerides Canola Oil Sunflower Oil Tocopherol Rosemary White Wax Olive Oil Cannabis Sativa Seed Oil Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-19
Description

Avobenzone 2.0% Octinoxate 6.5% Octisalate 5.0% Octocrylene 1.5%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Helps prevent sunburn

Dosage and Administration

Apply liberally 15 minutes before sun exposure

Description

Avobenzone 2.0% Octinoxate 6.5% Octisalate 5.0% Octocrylene 1.5%

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Rash Occurs

Section 50567-7

Keep out of eyes. Rinse well with water to remove.

Section 50570-1

on damaged or broken skin.

Section 51727-6

Sunflower Oil*, Beeswax, Olive Oil*, Flavor, Hemp Seed Oil*, Rosemary Extract, Tocopherol, Soybean Oil, Sunflower Seed Oil Glycerides, Aloe Extract, Canola Oil. * Organic

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Avobenzone 2.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Section 60562-6

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

Children under 6 months of age: Ask a doctor

Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Rash Occurs

Section 50567-7 (50567-7)

Keep out of eyes. Rinse well with water to remove.

Section 50570-1 (50570-1)

on damaged or broken skin.

Section 51727-6 (51727-6)

Sunflower Oil*, Beeswax, Olive Oil*, Flavor, Hemp Seed Oil*, Rosemary Extract, Tocopherol, Soybean Oil, Sunflower Seed Oil Glycerides, Aloe Extract, Canola Oil. * Organic

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Avobenzone 2.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Section 60562-6 (60562-6)

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

Children under 6 months of age: Ask a doctor

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:25.679954 · Updated: 2026-03-06T01:19:46.893304