Western Family Sport Sunscreen
FDA Label NDC 55312-005

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 Sport Sunscreen (NDC 55312-005). 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, when using this product, stop use and ask a doctor if, keep out of reach of children., other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Avobenzone 2.0 %

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 4.0%

Oxybenzone 5.0%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

When Using This Product

  • keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor If

  • rash or irritation develops and lasts

Keep Out Of Reach Of Children.

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

Other Information

  • protect this product from excessive heat and direct sun

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, Neopentyl Glycol Diheptanoate, Styrene/Acrylates Copolymer, Propylene Glycol, Polyglyceryl-3 Methylglucose Distearate, Benzyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Disodium EDTA, Oleth-3, Tocopherol, Chlorphenesin, Fragrance.


Principal Display Panel

WESTERN FAMILY

SPORT

Broad Spectrum SPF 30

SUNSCREEN LOTION

UVA/UVB protection

Wont Run into Eyes

Water Resistant (80 Minutes)


3 FL OZ ( 88 mL)

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WESTERN FAMILY

SPORT

Broad Spectrum SPF 30

SUNSCREEN LOTION

UVA/UVB protection

Wont Run into Eyes

Water Resistant (80 Minutes)


8 FL OZ ( 236 mL)

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