SPL v2
SPL
SPL Set ID 452b5997-d229-60ee-e063-6394a90a68db
Route
TOPICAL
Published
Effective Date 2026-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (0.1 g) Octinoxate (0.05 g) Octisalate (0.08 g) Octocrylene (0.03 g) Avobenzone
Inactive Ingredients
Diisopropyl Sebacate Chlorphenesin Ci 77499 Tocopherol Propanediol Arachidyl Glucoside Arginine Glyceryl Stearate Citrate Fragrance 13576 Butyloctyl Salicylate Sodium Stearoyl Glutamate Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Triethoxycaprylylsilane Niacinamide Glyceryl Stearate Hydroxyacetophenone Caprylyl Glycol Bht Ci 77891 1,2-hexanediol Sodium Hyaluronate Ci 77491 Potassium Cetyl Phosphate Edetate Disodium Magnesium Potassium Aluminosilicate Fluoride Behenyl Alcohol Polymethylsilsesquioxane (11 Microns) Water Glycerin Ethylhexyl Hydroxystearate Ci 77492 Lauryl Lactate Arachidyl Alcohol Caprylic/capric Triglyceride

Identifiers & Packaging

Pill Appearance
Color: yellow
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.

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 wallowed 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 befofe 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 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 51727-6

WATER, PROPANEDIOL, BUTYLOCTYL SALICYLATE, GLYCERIN, SYNTHETIC FLUORPHLOGOPITE, POTASSIUM CETYL PHOSPHATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, NIACINAMIDE, FRAGRANCE, GLYCERYL STEARATE, GLYCERYL STEARATE CITRATE, DIISOPROPYL SEBACATE, LAURYL LACTATE, 1,2-HEXANEDIOL, HYDROXYACETOPHENONE, CAPRYLYL GLYCOL, ARACHIDYL ALCOHOL, POLYMETHYLSILSESQUIOXANE, ETHYLHEXYL HYDROXYSTEARATE, BEHENYL ALCOHOL, SODIUM STEAROYL GLUTAMATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ARACHIDYL GLUCOSIDE, ARGININE, CHLORPHENESIN, DISODIUM EDTA, TOCOPHEROL, SODIUM HYALURONATE, TRIETHOXYCAPRYLYLSILANE, BHT, TITANIUM DIOXIDE(CI 77891), IRON OXIDES（CI 77492, CI 77491 ,CI 77499）

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 befofe 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)

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 wallowed 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, PROPANEDIOL, BUTYLOCTYL SALICYLATE, GLYCERIN, SYNTHETIC FLUORPHLOGOPITE, POTASSIUM CETYL PHOSPHATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, NIACINAMIDE, FRAGRANCE, GLYCERYL STEARATE, GLYCERYL STEARATE CITRATE, DIISOPROPYL SEBACATE, LAURYL LACTATE, 1,2-HEXANEDIOL, HYDROXYACETOPHENONE, CAPRYLYL GLYCOL, ARACHIDYL ALCOHOL, POLYMETHYLSILSESQUIOXANE, ETHYLHEXYL HYDROXYSTEARATE, BEHENYL ALCOHOL, SODIUM STEAROYL GLUTAMATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ARACHIDYL GLUCOSIDE, ARGININE, CHLORPHENESIN, DISODIUM EDTA, TOCOPHEROL, SODIUM HYALURONATE, TRIETHOXYCAPRYLYLSILANE, BHT, TITANIUM DIOXIDE(CI 77891), IRON OXIDES（CI 77492, CI 77491 ,CI 77499）

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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:14.640101 · Updated: 2026-03-14T23:12:24.385926