SPL v1
SPL
SPL Set ID 2be9f92a-a041-0595-e063-6394a90af7a8
Route
TOPICAL
Published
Effective Date 2014-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (80 mg) Zinc Oxide (38 mg)
Inactive Ingredients
Alumina .alpha.-tocopherol Acetate Hydrogen Dimethicone (20 Cst) Iron Oxides Dimethiconol (2000 Cst) Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Cyclohexasiloxane Tetrahexyldecyl Ascorbate Dimethicone Cyclopentasiloxane Dimethicone Crosspolymer Lauryl Peg/ppg-18/18 Methicone Peg-10 Dimethicone (600 Cst)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-03-01

Description

Titanium Dioxide 8% Zinc Oxide 3.8%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 8% Zinc Oxide 3.8%

Uses:

Helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Purpose:

Sunscreen

Warnings:

Stop use and ask a doctor if rash occurs.

Directions:

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating. Immediatley after towel drying. At leat every 2 hours.

Package Label:

Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

Inactive Ingredients:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate


Structured Label Content

Uses:

Helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Purpose:

Sunscreen

Warnings:

Stop use and ask a doctor if rash occurs.

Directions:

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating. Immediatley after towel drying. At leat every 2 hours.

Package Label:

Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

Inactive Ingredients:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate


Advanced Ingredient Data


Raw Label Data

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