Western Family Broad Spectrum Sunscreen
FDA Label NDC 55312-000

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Western Family Foods, Inc. for the product Western Family Broad Spectrum Sunscreen (NDC 55312-000). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, keep out of the reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor

→ Keep Out Of The Reach Of Children

→ Other Safety Information

→ Directions

→ Inactive Ingredients

→ Other Information

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredients

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 10.0%

Oxybenzone 6.0%

Purpose

Sunscreen

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

Warnings

For external use only

Do Not Use

on damaged or broken skin

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor

if rash occurs

Keep Out Of The Reach Of Children

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

Other Safety Information

May stain some fabrics.

Directions

apply liberally 15 minutes before sun exposure
reapply: after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
Sun Protection Measures.
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including
limit time in the sun especially from 10 a.m. - 2 p.m.
wear long-sleeve shirts, pants, hats and sunglasses
children under 6 months of age: Ask a doctor

Inactive Ingredients

Water, Glyceryl Stearate, Microcrystalline Cellulose, Butylene Glycol, PEG-100 Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Behenyl Alcohol, Butylated PVP, Palmitic Acid, Stearic Acid, C12-16 Alcohols, Cellulose Gum, Caprylic/Capric Triglyceride, Lecithin, Retinyl Palmitate, Tocopherol, Sodium Ascorbyl Phosphate, Disodium EDTA, Chlorphenesin.