SPL v1
SPL
SPL Set ID 451b7229-67d1-8b0e-e063-6394a90ab71e
Route
TOPICAL
Published
Effective Date 2026-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (0.05 g) Avobenzone (0.03 g) Homosalate (0.01 g) Octocrylene (0.08 g) Octinoxate
Inactive Ingredients
Aluminum Hydroxide Ricinus Communis (castor) Seed Oil Butylene Glycol Glyceryl Stearate Butyrospermum Parkii (shea) Butter Helianthus Annuus (sunflower) Seed Oil Glyceryl Caprylate Tocopherol Calophyllum Inophyllum Seed Oil Crocus Sativus Flower Polyhydroxystearic Acid (2300 Mw) Water Cetearyl Alcohol Ci 15985 Hydrogenated Castor Oil Butyloctyl Salicylate Sodium Chloride Fragrance 13576 Caprylic/capric Triglyceride Isododecane Cetyl Esters Euphorbia Cerifera (candelilla) Wax Cocos Nucifera (coconut) Oil Bht Sodium Sulfate

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-15
Description

Homosalate 10%, Octocrylene 8%, Octisalate 5%,Octinoxate 5%, Avobenzone 3%

Medication Information

Warnings and Precautions

For external use only.

Spending time in the sun increases your risk of skin Skin cancer/skin aging alert cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.



Do not use on damaged or broken skin.in the eye area.



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

Stop use and ask doctor if rash occurs.



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

Indications and Usage

Helps prevent sunburn.

Dosage and Administration

Apply generously and evenly 15 minutes before sun exposure.

Reapply at least every 2 hours.

Use a water resistant sunscreen if swimming or sweating.

Children under 6 month: ask a doctor.

Description

Homosalate 10%, Octocrylene 8%, Octisalate 5%,Octinoxate 5%, Avobenzone 3%

Section 50565-1

If product is swallowed get medical help or contact a poison control center right away.

Section 51945-4

Section 53413-1

1-212- 244-5170 | [email protected]

Section 55105-1

Sunscreen

Section 55106-9

Homosalate 10%, Octocrylene 8%, Octisalate 5%,Octinoxate 5%, Avobenzone 3%

Section 60561-8

Protect the product in this container from excessive heat and direct sun

Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn.

Dosage and Administration (34068-7)

Apply generously and evenly 15 minutes before sun exposure.

Reapply at least every 2 hours.

Use a water resistant sunscreen if swimming or sweating.

Children under 6 month: ask a doctor.

Warnings and Precautions (34071-1)

For external use only.

Spending time in the sun increases your risk of skin Skin cancer/skin aging alert cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.



Do not use on damaged or broken skin.in the eye area.



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

Stop use and ask doctor if rash occurs.



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

Section 50565-1 (50565-1)

If product is swallowed get medical help or contact a poison control center right away.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-212- 244-5170 | [email protected]

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Homosalate 10%, Octocrylene 8%, Octisalate 5%,Octinoxate 5%, Avobenzone 3%

Section 60561-8 (60561-8)

Protect the product in this container from excessive heat and direct sun

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:14.633248 · Updated: 2026-03-14T23:12:24.385926