Sun Defeated Sunscreen
FDA Label NDC 51702-114

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mission for the product Sun Defeated Sunscreen (NDC 51702-114). 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 otc - active ingredient, otc - purpose, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients:                                                               Purpose:

Avobenzone (3.0%)..............................................................Sunscreen

Octocrylene (7.0%)...............................................................Sunscreen

Oxybenzone (4.0%)...............................................................Sunscreen

Octisalate (8.0%)...................................................................Sunscreen

Otc - Purpose

  • Medium UVB sunburn/UVA protection
  • For skin highly sensitive to sunburn
  • Retains SPF after 80 minutes of activity

Warnings

Warnings: FOR EXTERNAL USE ONLY

UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using sunscreen.

  • When using this product keep out of eyes. Rinse with water to remove. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120 deg F.
  • Stop use and ask a doctor if skin rash occurs.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions:  Apply liberally before sun exposure. Apply and reapply, as directed to avoid lowering protection. Reapply after 80 minutes of swimming or sweating and after towel drying. Otherwise reapply at least every two hours. Children under 6 months: ask a doctor.

Inactive Ingredient

Aqua (Deionized Water), Glyceryl Stearate, Isopropyl Palmitate, Stearic Acid, PEG 100 Stearate, C 12-15 Alkyl Benzoate, Acrylates/C12-22 Alkylmethacrylates Copolymer, Sorbitol, Marshmallow Extract, Ivy Extract, Cucumber Extract, Elder Flower, Arnica Extract, Tocopheryl Acetate, Acrylates Copolymer, Cetyl Alcohol, Dimethicone, VP/Hexadecene Copolymer, Aloe Barbadenis Leaf Juice, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, EDTA, Phenoxyethanol, Ethylhexylglycerin

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