SPL v1
SPL
SPL Set ID 451b86fa-6c1c-a708-e063-6394a90a47a9
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) Octisalate (0.05 g) Octocrylene (0.09 g) Octinoxate (0.03 g) Avobenzone
Inactive Ingredients
Cocos Nucifera (coconut) Oil Dimethicone Fragrance 13576 Methyl Glucose Sesquistearate Butyrospermum Parkii (shea) Butter Phenoxyethanol Sodium Hyaluronate Ci 15985 Alpha-tocopherol Acetate Caprylic/capric Triglyceride Bht Steareth-20 Squalane Cetyl Alcohol Glyceryl Stearate Citrate Glyceryl Stearate Ethylhexylglycerin Polysorbate 60 Ci 19140 Caramel Glycerin Cetearyl Alcohol Water Peg-75 Stearate Inulin Lauryl Carbamate Sorbitan Isostearate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Glyceryl Caprylate Ceteth-20

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-20
Description

Homosalate 10%, Octocryene 9%, 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 doctor if m 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

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 month: ask a doctor.

Description

Homosalate 10%, Octocryene 9%, Octisalate 5% , Octinoxate 5% , Avobenzone 3%

Section 50565-1

Keep out of reach of children.lf product is swallowed get mecical help or contact a poison control center right away.

Section 51727-6

WATER, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, FRAGRANCE, DIMETHICONE, METHYL GLUCOSE SESQUISTEARATE, CETEARYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, COCOS NUCIFERA (COCONUT) OIL, GLYCERYL STEARATE CITRATE, GLYCERYL CAPRYLATE, PHENOXYETHANOL, GLYCERYL STEARATE, CETYL ALCOHOL, TOCOPHERYL ACETATE, SORBITAN ISOSTEARATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, PEG-75 STEARATE, INULIN LAURYL CARBAMATE, SQUALANE, CETETH-20, STEARETH-20, ETHYLHEXYLGLYCERIN, POLYSORBATE 60, SODIUM HYALURONATE, BHT, CARAMEL, FD&C YELLOW NO. 5 (CI 19140), FD&C YELLOW NO. 6 (CI 15985)

Section 51945-4

Section 53413-1

1-212-244-5170 [email protected]

Section 55105-1

Sunscreen

Section 55106-9

Homosalate 10%, Octocryene 9%, 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)

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 month: 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 doctor if m 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)

Keep out of reach of children.lf product is swallowed get mecical help or contact a poison control center right away.

Section 51727-6 (51727-6)

WATER, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, FRAGRANCE, DIMETHICONE, METHYL GLUCOSE SESQUISTEARATE, CETEARYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, COCOS NUCIFERA (COCONUT) OIL, GLYCERYL STEARATE CITRATE, GLYCERYL CAPRYLATE, PHENOXYETHANOL, GLYCERYL STEARATE, CETYL ALCOHOL, TOCOPHERYL ACETATE, SORBITAN ISOSTEARATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, PEG-75 STEARATE, INULIN LAURYL CARBAMATE, SQUALANE, CETETH-20, STEARETH-20, ETHYLHEXYLGLYCERIN, POLYSORBATE 60, SODIUM HYALURONATE, BHT, CARAMEL, FD&C YELLOW NO. 5 (CI 19140), FD&C YELLOW NO. 6 (CI 15985)

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%, Octocryene 9%, 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: 2026-02-15T12:07:49.075390 · Updated: 2026-03-14T23:11:40.308391