Extreme Sport Spf 70
FDA Label NDC 36800-727

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Top Care for the product Extreme Sport Spf 70 (NDC 36800-727). 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, warningsfor external use only, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients                  Purpose

Avobenzone - 3.00%               Sunscreen
Homosalate - 15.00%              Sunscreen
Octisalate - 5.00%                   Sunscreen
Octocrylene - 4.00%                Sunscreen
Oxybenzone - 6.00%               Sunscreen

Warningsfor External Use Only

Flammable: Do not use near heat, flame, or while smoking

Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing it. Do not puncture or incinerate. Contents under pressure. Do not store at temperature 120F

Stop use and ask a doctor if rash occurs

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: Ask a doctor

Inactive Ingredients

Acrylates/Dimethicone Copolymer, Acrylates/Octylacrylamide Copolymer, Alcohol Denat., Artemia Extract, Ascorbyl Palmitate, Butyloctyl Salicylate, Cyclopentasiloxane, Fragrance, Glycerin, Polyester-8, Retinyl Palmitate, Tocopheryl Acetate

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