Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID bf4bfedd-d601-4378-a90a-28375f9daf99
Route
CUTANEOUS
Published
Effective Date 2011-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.25 mL) Titanium (2.12 mL) Zinc Cation (1.75 mL)
Inactive Ingredients
Water Cyclomethicone Squalane Propylene Glycol Dimethicone Trolamine Hexyl Laurate Sorbitan Sesquioleate Glycerin Tomato Magnesium Aluminum Silicate Silicon Dioxide Aluminum Oxide Methylparaben Propylparaben Imidurea

Identifiers & Packaging

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

Active ingredients: OCTINOXATE 6.5%, Titanium Dioxide 4.24%, Zinc Oxide 3.5%

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 6.5%, Titanium Dioxide 4.24%, Zinc Oxide 3.5%

Section 50565-1

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6

Inactive ingredients:

Water, Cyclomethicone, Dimethicone, Squalane, Dimethicone/Vinyl Dimethicone Crosspolymer, PEG-10 Dimethicone, Propylene Glycol, Triethanolamine, Dimethicone Copolyol, Hexyl Laurate, Cetyl Peg/Ppg-10/1 Dimethicone, Sorbitan Sesquioleate, Glycerin, Solanum Lycopersicum (Tomato) Extract, Silica, Stearalkonium Hectorite, Magnesium Aluminum Silicate, Alumina, Methylparaben, Fragrance, Propylparaben, Imidazolidinyl Urea

Section 51945-4

Section 55105-1

Purpose: Protects skin from UV rays.

Section 55106-9

Active ingredients: OCTINOXATE 6.5%, Titanium Dioxide 4.24%, Zinc Oxide 3.5%

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, Cyclomethicone, Dimethicone, Squalane, Dimethicone/Vinyl Dimethicone Crosspolymer, PEG-10 Dimethicone, Propylene Glycol, Triethanolamine, Dimethicone Copolyol, Hexyl Laurate, Cetyl Peg/Ppg-10/1 Dimethicone, Sorbitan Sesquioleate, Glycerin, Solanum Lycopersicum (Tomato) Extract, Silica, Stearalkonium Hectorite, Magnesium Aluminum Silicate, Alumina, Methylparaben, Fragrance, Propylparaben, Imidazolidinyl Urea

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Protects skin from UV rays.

Section 55106-9 (55106-9)

Active ingredients: OCTINOXATE 6.5%, Titanium Dioxide 4.24%, Zinc Oxide 3.5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:21.037038 · Updated: 2026-03-14T22:52:53.430326