Solbar Fifty Spf50

Solbar Fifty Spf50
SPL v17
SPL
SPL Set ID 41fd3844-181c-4cb2-8379-f313104351ef
Route
TOPICAL
Published
Effective Date 2014-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (0.1 g) Octinoxate (0.08 g) Oxybenzone (0.06 g) Avobenzone (0.011 g)
Inactive Ingredients
Water Propylene Glycol Diethylhexanoate Dimethicone Eicosyl Povidone (2 Eicosyl Branches/repeat) Stearic Acid Cetyl Phosphate Glycerin Benzyl Alcohol Cetyl Alcohol Carbomer 1342 Trolamine

Identifiers & Packaging

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

Description

Sun screen

Purpose

Sun screen


Medication Information

Purpose

Sun screen

Description

Sun screen

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.

Otc Purpose Section

Sun screen

Inactive Ingredient Section

Purified Water

Propylene Glycol Diethylhexanoate

Dimethicone

PVP/Eicosene Copolymer

Stearic Acid

Cetyl Phosphate

Glycerin

Benzyl Alcohol

Cetyl Alcohol

Carbomer 1342

Triethanolamine

Indications & Usage Section

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

Dosage & Administration Section

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.

Otc Active Ingredient Section

Octocrylene

Ethylhexyl Methoxycinnamate

Oxybenzone

Avobenzone

Package Labe; Principal Display Panel

Otc Keep Out of Reach of Children Section

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


Structured Label Content

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.

Otc Purpose Section (OTC - PURPOSE SECTION)

Sun screen

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Purified Water

Propylene Glycol Diethylhexanoate

Dimethicone

PVP/Eicosene Copolymer

Stearic Acid

Cetyl Phosphate

Glycerin

Benzyl Alcohol

Cetyl Alcohol

Carbomer 1342

Triethanolamine

Indications & Usage Section (INDICATIONS & USAGE SECTION)

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

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

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.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Octocrylene

Ethylhexyl Methoxycinnamate

Oxybenzone

Avobenzone

Package Labe; Principal Display Panel

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)