2be9f92a-a041-0595-e063-6394a90af7a8

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

Purpose

Sunscreen

Description

Titanium Dioxide 8% Zinc Oxide 3.8%


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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