SPL v1
SPL
SPL Set ID 4524129b-f8aa-171b-e063-6294a90aeebe
Route
TOPICAL
Published
Effective Date 2026-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (0.05 g) Octocrylene (0.08 g) Octisalate (0.1 g) Homosalate (0.03 g) Avobenzone
Inactive Ingredients
Potassium Cetyl Phosphate Ammonium Polyacryloyldimethyl Taurate Ci 77499 Ci 77491 Caprylyl Glycol Bisabolol Dimethicone Hydrogenated Soybean Oil Arachidyl Alcohol Prunus Amygdalus Dulcis (sweet Almond) Oil Coffea Arabica (coffee) Seed Oil Tocopherol Ethylhexylglycerin Sodium Stearoyl Glutamate Glyceryl Stearate Citrate Ci 77492 Behenyl Alcohol Butyrospermum Parkii (shea) Butter Butyloctyl Salicylate Glyceryl Stearate Fragrance 13576 Phenoxyethanol Arachidyl Glucoside Sodium Hyaluronate Bht Glycerin Water C13-15 Alkane

Identifiers & Packaging

Pill Appearance
Color: brown
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 io remove

Stop use and ask 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 sunbum.

Dosage and Administration

Apply generously and evenly 15 minutes belore sun exposure.

Reapply at least every 2 hours.

Use a water resistant sunscreen if swimming ors weating.

Children under 6 month: 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, BUTYLOCTYL SALICYLATE, C13-15 ALKANE, GLYCERIN, POTASSIUM CETYL PHOSPHATE, DIMETHICONE, BEHENYL ALCOHOL, GLYCERYL STEARATE, GLYCERYL STEARATE CITRATE, ARACHIDYL ALCOHOL, FRAGRANCE, PHENOXYETHANOL, CAPRYLYL GLYCOL, BISABOLOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, ARACHIDYL GLUCOSIDE, AMMONIUM POLYACRYLOYLDIMETHYL TAURATE, SODIUM STEAROYL GLUTAMATE, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, HYDROGENATED VEGETABLE OIL, ETHYLHEXYLGLYCERIN, COFFEA ARABICA (COFFEE) SEED OIL, SODIUM HYALURONATE, BHT, TOCOPHEROL, 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 sunbum.

Dosage and Administration (34068-7)

Apply generously and evenly 15 minutes belore sun exposure.

Reapply at least every 2 hours.

Use a water resistant sunscreen if swimming ors weating.

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 on damaged or broken skin.

When using this product keep out of eyes. rinse with water io remove

Stop use and ask 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)

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

Section 51727-6 (51727-6)

WATER, BUTYLOCTYL SALICYLATE, C13-15 ALKANE, GLYCERIN, POTASSIUM CETYL PHOSPHATE, DIMETHICONE, BEHENYL ALCOHOL, GLYCERYL STEARATE, GLYCERYL STEARATE CITRATE, ARACHIDYL ALCOHOL, FRAGRANCE, PHENOXYETHANOL, CAPRYLYL GLYCOL, BISABOLOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, ARACHIDYL GLUCOSIDE, AMMONIUM POLYACRYLOYLDIMETHYL TAURATE, SODIUM STEAROYL GLUTAMATE, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, HYDROGENATED VEGETABLE OIL, ETHYLHEXYLGLYCERIN, COFFEA ARABICA (COFFEE) SEED OIL, SODIUM HYALURONATE, BHT, TOCOPHEROL, 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

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Source: dailymed · Ingested: 2026-02-15T12:08:14.638814 · Updated: 2026-03-14T23:12:24.385926