SPL v1
SPL
SPL Set ID 4517da75-c91a-1f93-e063-6394a90a65ac
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) Homosalate (0.15 g) Octocrylene (0.1 g) Avobenzone (0.03 g)
Inactive Ingredients
Alcohol Butyloctyl Salicylate Cetrimonium Chloride Artemisia Argyi Leaf Isododecane Fragrance 13576

Identifiers & Packaging

Pill Appearance
Shape: freeform Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-15

Description

Homosalate 15%, Octocrylene 10%, Octisalate 5% , Avobenzone 3%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Skin cancer/skin aging alert

Spending time in the sun increases your risk of skin 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.

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.

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

Indications and Usage

Helps prevent sunburn.

Dosage and Administration

DirectionS

Apply generously and evenly 15 minutes before sun exposure.

Hold container 4 to 6 inches from the skin to apply.

Do not spray directly into face.

Spray on hands then apply to face.

Do not apply in windy conditions.

Use in a well-ventilated area and avoid inhalation.

Reapply at least every 2 hours.

Shake it up and down 3-5 seconds before use.

Use a water resistant sunscreen if swimming or sweating.

Children under 6 month: ask a doctor.

Description

Homosalate 15%, Octocrylene 10%, Octisalate 5% , Avobenzone 3%

Section 50565-1

Keep out of reach of children.

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

Section 51727-6

ALCOHOL DENAT, ISODODECANE ,BUTYLOCTYL SALICYLATE , FRAGRANCE , ARTEMISIA ARGYILEAF OIL, CETRIMONIUM CHLORIDE , ALCOHOL

Section 51945-4

Section 53413-1

1-212-244-5170 [email protected]

Section 55105-1

sunscreen

Section 55106-9

Homosalate 15%, Octocrylene 10%, Octisalate 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)

DirectionS

Apply generously and evenly 15 minutes before sun exposure.

Hold container 4 to 6 inches from the skin to apply.

Do not spray directly into face.

Spray on hands then apply to face.

Do not apply in windy conditions.

Use in a well-ventilated area and avoid inhalation.

Reapply at least every 2 hours.

Shake it up and down 3-5 seconds before use.

Use a water resistant sunscreen if swimming or sweating.

Children under 6 month: ask a doctor.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Skin cancer/skin aging alert

Spending time in the sun increases your risk of skin 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.

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.

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

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 51727-6 (51727-6)

ALCOHOL DENAT, ISODODECANE ,BUTYLOCTYL SALICYLATE , FRAGRANCE , ARTEMISIA ARGYILEAF OIL, CETRIMONIUM CHLORIDE , ALCOHOL

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 15%, Octocrylene 10%, Octisalate 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)