SPL v1
SPL
SPL Set ID 452bd24d-8654-e6c0-e063-6394a90a0aea
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 (0.15 g) Octocrylene (0.1 g)
Inactive Ingredients
Fragrance 13576 Alpha-tocopherol Acetate Silica Edetate Disodium Propylene Glycol Simmondsia Chinensis (jojoba) Seed Oil Allantoin Methicone (20 Cst) Xanthan Gum Peg-100 Stearate Phenoxyethanol Water Ethylhexylglycerin Trehalose Potassium Cetyl Phosphate Cocos Nucifera (coconut) Oil Butyrospermum Parkii (shea) Butter Behenyl Alcohol Glyceryl Stearate 1,2-hexanediol Cetearyl Alcohol

Identifiers & Packaging

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

Description

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


Medication Information

Warnings and Precautions

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 m on damaged or broken skin.

When using this product keep out of eves. 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

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

Section 50565-1

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

Section 51727-6

WATER,PROPYLENE GLYCOL,BEHENYL ALCOHOL,GLYCERYL STEARATE,CETEARYL ALCOHOL,PEG-100 STEARATE,1,2-HEXANEDIOL,PHENOXYETHANOL,FRAGRANCE,POTASSIUM CETYL PHOSPHATE,SILICA,XANTHAN GUM,TREHALOSE,SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL,TOCOPHERYL ACETATE,COCOS NUCIFERA (COCONUT) OIL,BUTYROSPERMUM PARKII (SHEA) BUTTER,ETHYLHEXYLGLYCERIN,DISODIUM EDTA,ALLANTOIN,METHICONE

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)

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.

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 m on damaged or broken skin.

When using this product keep out of eves. 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)

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

Section 51727-6 (51727-6)

WATER,PROPYLENE GLYCOL,BEHENYL ALCOHOL,GLYCERYL STEARATE,CETEARYL ALCOHOL,PEG-100 STEARATE,1,2-HEXANEDIOL,PHENOXYETHANOL,FRAGRANCE,POTASSIUM CETYL PHOSPHATE,SILICA,XANTHAN GUM,TREHALOSE,SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL,TOCOPHERYL ACETATE,COCOS NUCIFERA (COCONUT) OIL,BUTYROSPERMUM PARKII (SHEA) BUTTER,ETHYLHEXYLGLYCERIN,DISODIUM EDTA,ALLANTOIN,METHICONE

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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