Western Family Broad Spectrum Sunscreen

Western Family Foods, Inc.

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients
• Purpose
• Western Family Broad Spectrum Sunscreen Uses
• Warnings
  • Do not use
  • When using this product
  • Stop use and ask a doctor
  • Keep out of the reach of children
• Directions
• Inactive ingredients
• Western Family Broad Spectrum Sunscreen Other information
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 10.0%

Oxybenzone 6.0%

Purpose

Sunscreen

Western Family Broad Spectrum 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.

• 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.

Western Family Broad Spectrum Sunscreen Other information

• protect this product from excessive heat and direct sun
  

Questions or comments?

Call 1-503-639-6300

Principal Display Panel

WESTERN FAMILY

Broad Spectrum SPF 70

sunscreen lotion

UVA/UVB protection

moisturizing with vitamin e

water resistant

(80 minutes)

8 FL OZ (236 mL)

Western Family Broad Spectrum Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION Product Information Product Type Human otc drug label Item Code (Source) NDC:55312-000 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE AVOBENZONE 3 g HOMOSALATE Homosalate 15 g OCTISALATE OCTISALATE 5 g OCTOCRYLENE Octocrylene 10 g OXYBENZONE OXYBENZONE 6 g Inactive Ingredients Ingredient Name Strength water GLYCERYL MONOSTEARATE cellulose, microcrystalline BUTYLENE GLYCOL PEG-100 STEARATE BENZYL ALCOHOL Diethylhexyl Syringylidenemalonate docosanol PALMITIC ACID STEARIC ACID CARBOXYMETHYLCELLULOSE SODIUM TRICAPRYLIN VITAMIN A PALMITATE Tocopherol SODIUM ASCORBYL PHOSPHATE EDETATE DISODIUM CHLORPHENESIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55312-000-56 226 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date part part352 2014-03-03