SPL v1
SPL
SPL Set ID 3480b60e-21b1-84f3-e063-6294a90abc65
Route
TOPICAL
Published
Effective Date 2025-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (50 mg) Homosalate (73 mg) Zinc Oxide (136.8 mg)
Inactive Ingredients
Butyloctyl Salicylate Polyhydroxystearic Acid (2300 Mw) Butylene Glycol Glyceryl Stearate Triethoxycaprylylsilane Xanthan Gum Glycerin Dimethicone Polysorbate 80 Isohexadecane Ethylhexylglycerin Sodium Hydroxide Isostearic Acid Cetearyl Alcohol Coco-glucoside Hydroxyacetophenone Benzotriazolyl Dodecyl P-cresol Phenoxyethanol Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Water Isononyl Isononanoate Ethylhexyl Methoxycrylene Potassium Cetyl Phosphate Peg-100 Stearate Citric Acid Trisodium Ethylenediamine Disuccinate Caprylic/capric Triglyceride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-06
Description

Active Ingredients Homosalate...............7.3% Octisalate.............5% Zinc Oxide.............13.68%

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

  • Helps prevents sunburn
  • If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun
Dosage and Administration

DIrections

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating
Description

Active Ingredients Homosalate...............7.3% Octisalate.............5% Zinc Oxide.............13.68%

Section 44425-7

Other information

  • Protect this product form excessive heat and direct sun
  • May stain some fabrics
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

INACTIVE INGREDIENTS: AQUA/WATER/EAU, GLYCERIN, ISONONUL ISONONANOATE, BUTYLOCTYL SALICYLATE, BUTYLENE GLYCOL, ETHYLHEXYL METHOXYCRYLENE, CETEARYL ALCOHOL, POTASSIUM CETYL PHOSPHATE, DIMETHICONE, SILICA, CAMELLIA SINENSIS LEAF EXTRACT, CENTELLA ASIATICA EXTRACT, GINKGO BILOBA LEAF EXTRACT, HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF EXTRACT, LENS ESCULENTA (LENTIL) SEED EXTRACT, ALOE BARBADENSIS LEAF JUICE POWDER, CRITHMUM MARITIMUM EXTRACT, PONGAMIA PINNATA SEED EXTRACT, AZELAIC ACID, GLYCERYL STEARATE, PEG-100 STEARATE, POLYHYDROXYSTEARIC ACID, COCO-GLUCOSIDE, TRIETHOXYCAPRYLYLSILANE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOHEXADECANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROXYACETOPHENONE, XANTHAN GUM, CITRIC ACID, BENZOTRIAZOLYL DODECYL P-CRESOL, ETHYLHEXYLGLYCERIN, POLYSORBATE 80, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, ISOSTEARIC ACID, LECITHIN, POLYGLYCERYL-3 POLYRICINOLEATE, SODIUM HYDROXIDE, PHENOXYETHANOL

Section 51945-4

Section 55105-1

Purpose

..........Sunscreen

Section 55106-9

Active Ingredients

Homosalate...............7.3%

Octisalate.............5%

Zinc Oxide.............13.68%

Structured Label Content

Indications and Usage (34067-9)

Uses

  • Helps prevents sunburn
  • If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun
Dosage and Administration (34068-7)

DIrections

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

  • Protect this product form excessive heat and direct sun
  • May stain some fabrics
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: AQUA/WATER/EAU, GLYCERIN, ISONONUL ISONONANOATE, BUTYLOCTYL SALICYLATE, BUTYLENE GLYCOL, ETHYLHEXYL METHOXYCRYLENE, CETEARYL ALCOHOL, POTASSIUM CETYL PHOSPHATE, DIMETHICONE, SILICA, CAMELLIA SINENSIS LEAF EXTRACT, CENTELLA ASIATICA EXTRACT, GINKGO BILOBA LEAF EXTRACT, HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF EXTRACT, LENS ESCULENTA (LENTIL) SEED EXTRACT, ALOE BARBADENSIS LEAF JUICE POWDER, CRITHMUM MARITIMUM EXTRACT, PONGAMIA PINNATA SEED EXTRACT, AZELAIC ACID, GLYCERYL STEARATE, PEG-100 STEARATE, POLYHYDROXYSTEARIC ACID, COCO-GLUCOSIDE, TRIETHOXYCAPRYLYLSILANE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOHEXADECANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROXYACETOPHENONE, XANTHAN GUM, CITRIC ACID, BENZOTRIAZOLYL DODECYL P-CRESOL, ETHYLHEXYLGLYCERIN, POLYSORBATE 80, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, ISOSTEARIC ACID, LECITHIN, POLYGLYCERYL-3 POLYRICINOLEATE, SODIUM HYDROXIDE, PHENOXYETHANOL

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

..........Sunscreen

Section 55106-9 (55106-9)

Active Ingredients

Homosalate...............7.3%

Octisalate.............5%

Zinc Oxide.............13.68%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:04.208830 · Updated: 2026-03-14T23:08:36.803157