Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 940c6da8-1168-4488-96af-fdd9b8f36c46
Route
CUTANEOUS
Published
Effective Date 2011-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.5 mL) Titanium (2.05 mL) Zinc Cation (1.43 mL)
Inactive Ingredients
Water Cyclomethicone 5 Silicon Dioxide Propylene Glycol Squalane Glycerin Sorbitan Sesquioleate Butylene Glycol Lecithin, Soybean Triethoxycaprylylsilane Aluminum Hydroxide Stearic Acid Methylparaben Phenoxyethanol Propylparaben Tomato Trolamine Adenosine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-03-01
Description

Active ingredients: OCTINOXATE 7%, TITANIUM DIOXIDE 4.1%, ZINC OXIDE 2.85%

Medication Information

Warnings and Precautions

Warnings:

For external use only.

Avoid contact with eyes.

Discontinue use if signs of irritation appear.

Indications and Usage

Indication and usage:

Use at the end of your daily skincare regimen.

Apply liberally onto face and body before sun exposure avoiding the eye area.

Dosage and Administration

Dosage and administration:

For best results, apply at least 15 to 20 minutes before sun exposure.

Reapply frequently while out in the sun.

Description

Active ingredients: OCTINOXATE 7%, TITANIUM DIOXIDE 4.1%, ZINC OXIDE 2.85%

Section 50565-1

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6

Inactive ingredients:

WATER, CYCLOPENTASILOXANE, ISOAMYL p-METHOXYCINNAMATE, CETYL PEG/PPG-10/1 DIMETHICONE, PROPYLENE GLYCOL, SQUALANE, GLYCERIN, SORBITAN SESQUIOLEATE, STEARALKONIUM HECTORITE, BUTYLENE GLYCOL, LECITHIN, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PEG-10 DIMETHICONE, OZOKERITE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, ALUMINUM HYDROXIDE, STEARIC ACID, DIMETHICONE/METHICONE COPOLYMER, POLYMETHYL METHACRYLATE, SOLANUM LYCOPERSICUM (TOMATO) FRUIT EXTRACT, ADENOSINE, TRIETHANOLAMINE, METHYLPARABEN, PROPYLPARABEN, PHENOXYETHANOL, FRAGRANCE, SILICA



Section 51945-4

Section 55105-1

Purpose: Protects skin from UV rays.

Section 55106-9

Active ingredients: OCTINOXATE 7%, TITANIUM DIOXIDE 4.1%, ZINC OXIDE 2.85%

Structured Label Content

Indications and Usage (34067-9)

Indication and usage:

Use at the end of your daily skincare regimen.

Apply liberally onto face and body before sun exposure avoiding the eye area.

Dosage and Administration (34068-7)

Dosage and administration:

For best results, apply at least 15 to 20 minutes before sun exposure.

Reapply frequently while out in the sun.

Warnings and Precautions (34071-1)

Warnings:

For external use only.

Avoid contact with eyes.

Discontinue use if signs of irritation appear.

Section 50565-1 (50565-1)

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients:

WATER, CYCLOPENTASILOXANE, ISOAMYL p-METHOXYCINNAMATE, CETYL PEG/PPG-10/1 DIMETHICONE, PROPYLENE GLYCOL, SQUALANE, GLYCERIN, SORBITAN SESQUIOLEATE, STEARALKONIUM HECTORITE, BUTYLENE GLYCOL, LECITHIN, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PEG-10 DIMETHICONE, OZOKERITE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, ALUMINUM HYDROXIDE, STEARIC ACID, DIMETHICONE/METHICONE COPOLYMER, POLYMETHYL METHACRYLATE, SOLANUM LYCOPERSICUM (TOMATO) FRUIT EXTRACT, ADENOSINE, TRIETHANOLAMINE, METHYLPARABEN, PROPYLPARABEN, PHENOXYETHANOL, FRAGRANCE, SILICA



Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Protects skin from UV rays.

Section 55106-9 (55106-9)

Active ingredients: OCTINOXATE 7%, TITANIUM DIOXIDE 4.1%, ZINC OXIDE 2.85%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:20.508248 · Updated: 2026-03-14T22:52:50.897919