Solbar Zinc

Solbar Zinc
SPL v11
SPL
SPL Set ID fac62a2f-92ee-4afd-9999-bc5011159e43
Route
TOPICAL
Published
Effective Date 2014-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (0.1015 g) Octinoxate (0.077 g) Zinc Cation
Inactive Ingredients
Water Isobutyl Stearate Peg-100 Stearate Glycerin Dimethicone Eicosyl Povidone (2 Eicosyl Branches/repeat) Glyceryl Dilaurate Cetyl Alcohol Diethanolamine Cetyl Phosphate Benzyl Alcohol Cyclomethicone Stearyl Alcohol Xanthan Gum Edetate Sodium Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1996-06-01

Description

Helps prevent sunburn.

Purpose

Sunscreen

Dosage and Administration

Apply liberally and evenly to all sun exposed areas of DRY skin 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating and immediately after towel drying. Apply at least every 2 hours. For children under 6 months, ask a physician.


Medication Information

Purpose

Sunscreen

Dosage and Administration

Apply liberally and evenly to all sun exposed areas of DRY skin 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating and immediately after towel drying. Apply at least every 2 hours. For children under 6 months, ask a physician.

Description

Helps prevent sunburn.

Warnings

For external use only. Do not use on damaged or broken skin. Keep out of eyes. Rinse eyes thoroughly with water to remove. Stop use and ask a physician if rash or irritation develops and lasts. Store away from excessive heat and direct sun.

Solbar Zinc

Indications and Use

Helps prevent sunburn.

Inactive Ingredient Section

Water

Isobutyl Stearate

PEG-100 Stearate

Glycerin

Dimethicone

PVP/Eicosene Copolymer

Glyceryl Dilaurate

Cetyl Alcohol

DEA Cetyl Phosphate

Benzyl Alcohol

Cyclomethicone

Stearyl Alcohol

Xanthan Gum

Disodium EDTA

Citric Acid

Otc Active Ingredient Section

Homosalate

Octinoxate

Zinc Oxide

Keep Out of the Reach of Children

Yes. If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Purpose

Sunscreen

Warnings

For external use only. Do not use on damaged or broken skin. Keep out of eyes. Rinse eyes thoroughly with water to remove. Stop use and ask a physician if rash or irritation develops and lasts. Store away from excessive heat and direct sun.

Solbar Zinc

Indications and Use (Indications and use)

Helps prevent sunburn.

Dosage and Administration

Apply liberally and evenly to all sun exposed areas of DRY skin 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating and immediately after towel drying. Apply at least every 2 hours. For children under 6 months, ask a physician.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Water

Isobutyl Stearate

PEG-100 Stearate

Glycerin

Dimethicone

PVP/Eicosene Copolymer

Glyceryl Dilaurate

Cetyl Alcohol

DEA Cetyl Phosphate

Benzyl Alcohol

Cyclomethicone

Stearyl Alcohol

Xanthan Gum

Disodium EDTA

Citric Acid

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Homosalate

Octinoxate

Zinc Oxide

Keep Out of the Reach of Children (Keep out of the reach of children)

Yes. If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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