SPL v2
SPL
SPL Set ID 451bb734-d54d-e24e-e063-6394a90a1adb
Route
TOPICAL
Published
Effective Date 2026-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-25
Description

Homosalate 10%, Octocrylene 8%, Octisalate 5%, Octinoxate 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. 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 months: ask a doctor.

Description

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

Section 50565-1

Keep out of reach of children.

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

Section 51727-6

WATER, PROPANEDIOL, BUTYLOCTYL SALICYLATE, GLYCERIN, MICA, POTASSIUM CETYL PHOSPHATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, NIACINAMIDE, GLYCERYL STEARATE, GLYCERYL STEARATE CITRATE, DIISOPROPYL SEBACATE, LAURYL LACTATE, FRAGRANCE, 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, TIN OXIDE, TOCOPHEROL, SODIUM HYALURONATE, BHT, TRIETHOXYCAPRYLYLSILANE, TITANIUM DIOXIDE(CI 77891), IRON OXIDES（CI 77491,CI 77492）

Section 51945-4

Section 53413-1

[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 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. If 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.

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, MICA, POTASSIUM CETYL PHOSPHATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, NIACINAMIDE, GLYCERYL STEARATE, GLYCERYL STEARATE CITRATE, DIISOPROPYL SEBACATE, LAURYL LACTATE, FRAGRANCE, 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, TIN OXIDE, TOCOPHEROL, SODIUM HYALURONATE, BHT, TRIETHOXYCAPRYLYLSILANE, TITANIUM DIOXIDE(CI 77891), IRON OXIDES（CI 77491,CI 77492）

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

[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: 2026-02-15T12:08:21.194301 · Updated: 2026-03-14T23:12:34.529887