Drug Facts

Composition & Product

Active Ingredients

Avobenzone (3 g) Homosalate (13 g) Octisalate (5 g) Octocrylene (7 g) Oxybenzone (4 g)

Inactive Ingredients

Water Sorbitol Stearic Acid Trolamine Aluminum Starch Octenylsuccinate Benzyl Alcohol Sorbitan Isostearate Polyglyceryl-3 Distearate Tocopherol Edetate Disodium Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2014-07-02

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0% Homosalate 13.0% Octisalate 5.0% Octocrylene 7.0% Oxybenzone 4.0%

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

Section 60561-8

May stain some fabrics.

Warnings

For external use only

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

Do Not Use

on damaged or broken skin

Other Information

protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 3.0%

Homosalate 13.0%

Octisalate 5.0%

Octocrylene 7.0%

Oxybenzone 4.0%

Inactive Ingredients

Water, Sorbitol, Stearic Acid, Triethanolamine, Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Sorbitan Isostearate, VP/Eicosene Copolymer, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben, Fragrance.

Questions Or Comments?

Call 1-503-639-6300

Principal Display Panel

WESTERN FAMILY

baby Broad Spectrum SPF 50

sunscreen lotion

UVA/UVB protection

pediatrician tested

water resistant

(80 minutes)

10 FL OZ (295 mL)

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.

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

Section 60561-8 (60561-8)

May stain some fabrics.

Purpose

Sunscreen

Warnings

For external use only

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

Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)

protect this product from excessive heat and direct sun

Active Ingredients (Active ingredients)

Avobenzone 3.0%

Homosalate 13.0%

Octisalate 5.0%

Octocrylene 7.0%

Oxybenzone 4.0%

Inactive Ingredients (Inactive ingredients)

Water, Sorbitol, Stearic Acid, Triethanolamine, Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Sorbitan Isostearate, VP/Eicosene Copolymer, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben, Fragrance.

Questions Or Comments? (Questions or comments?)

Call 1-503-639-6300

Principal Display Panel

WESTERN FAMILY

baby Broad Spectrum SPF 50

sunscreen lotion

UVA/UVB protection

pediatrician tested

water resistant

(80 minutes)

10 FL OZ (295 mL)

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

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

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "60561-8": "May stain some fabrics.", "Purpose": "Sunscreen", "Warnings": "For external use only", "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", "Do not use": "on damaged or broken skin", "Other information": "protect this product from excessive heat and direct sun", "Active ingredients": "Avobenzone 3.0% Homosalate 13.0% Octisalate 5.0% Octocrylene 7.0% Oxybenzone 4.0%", "Inactive ingredients": "Water, Sorbitol, Stearic Acid, Triethanolamine, Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Sorbitan Isostearate, VP/Eicosene Copolymer, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben, Fragrance.", "Questions or comments?": "Call 1-503-639-6300", "Principal Display Panel": "WESTERN FAMILY baby Broad Spectrum SPF 50 sunscreen lotion UVA/UVB protection pediatrician tested water resistant (80 minutes) 10 FL OZ (295 mL)", "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."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information