SPL v1
SPL
SPL Set ID 16ca3994-c488-2612-e063-6394a90af313
Route
TOPICAL
Published
Effective Date 2024-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-23
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 mintues 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

Stop use and ask a doctor if 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%

Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn

Dosage and Administration (34068-7)

Apply liberally 15 mintues 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)

Stop use and ask a doctor if 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%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:59.896946 · Updated: 2026-03-06T01:19:15.909915