SPL v1
SPL
SPL Set ID 451b662a-70ed-8ec5-e063-6294a90a005b
Route
TOPICAL
Published
Effective Date 2026-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (0.03 g) Octisalate (0.05 g) Octocrylene (0.1 g) Homosalate (0.15 g)
Inactive Ingredients
Acrylates/octylacrylamide Copolymer (40000 Mw) Dicaprylyl Carbonate Butyloctyl Salicylate Triethyl Citrate Alcohol Ci 77491 Magnesium Potassium Aluminosilicate Fluoride Ci 77891 Mica Alpha-tocopherol Acetate Lauryl Lactate Diisopropyl Adipate Fragrance 13576 Water

Identifiers & Packaging

Pill Appearance
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 a doctor if rash occurs.

Keep out of reach of children.

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

Indications and Usage

Helps prevent sunburn

Dosage and Administration

Directions

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 months: ask a doctor.

Description

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

Section 50565-1

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

Section 51727-6

ALCOHOL,BUTYLOCTYL SALICYLATE,WATER,DIISOPROPYL ADIPATE,LAURYL LACTATE,DICAPRYLYL CARBONATE,TRIETHYL CITRATE,FRAGRANCE,TOCOPHERYL ACETATE,ACRYLATES/OCTYLACRYLAMIDE COPOLYMER,SYNTHETIC FLUORPHLOGOPITE,MICA,TITANIUM DIOXIDE(CI 77891),IRON OXIDES (CI 77491)

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.

Reapply at least every 2 hours.

Use a water resistant sunscreen if swimming or sweating.

Children under 6 months: 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 a doctor if rash occurs.

Keep out of reach of children.

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

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

ALCOHOL,BUTYLOCTYL SALICYLATE,WATER,DIISOPROPYL ADIPATE,LAURYL LACTATE,DICAPRYLYL CARBONATE,TRIETHYL CITRATE,FRAGRANCE,TOCOPHERYL ACETATE,ACRYLATES/OCTYLACRYLAMIDE COPOLYMER,SYNTHETIC FLUORPHLOGOPITE,MICA,TITANIUM DIOXIDE(CI 77891),IRON OXIDES (CI 77491)

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

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