Defend Hydrating Broad Spectrum Spf 15
FDA Label NDC 70384-100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Profile 4 Men Llc for the product Defend Hydrating Broad Spectrum Spf 15 (NDC 70384-100). 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:, warnings:, directions:, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Homosolate..............................8.0%
 Avobenzone ............................3.0%Purpose: Sunscreen
Octisalate.................................5.0%

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

Directions:

  • Apply to neck and face before exposure to the sun and the light of day.
  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating, reapply at least every two hours.
  • Children under 6 months. Ask a doctor.

    • USE ONLY AS DIRECTED.

    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularaly use a sunscreen with a Broad Spectrum value of SPF 15 or higher and other sun protection measures including:

    • Limit time in the sun, especially from 10 a.m.-2p.m.
    • Wear long-sleeved shirts, pants, hats and sunglasses

Inactive Ingredients

Water/Aqua/Eau, Silica, Caprylic/Capric Triglyceride, Glycerin, Xylitylglucoside, Anhydroxylitol, Xylitol, Chondrus Crispus Extract, Sodium Hyaluronate, Glyceryl Stearate, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Tocopheryl Acetate, Ilex Paraguariensis Leaf Extract, Avena Sativa (Oat) Kernel Extract, Vegetable Collagen, Stearic Acid, Polymethyl Methacrylate, Di-C12-15 Alkyl Fumarate, Cetyl Phosphate, Disodium EDTA, Carbomer, Fragrance, Aminomethyl Propanol, Phenoxyethanol, Caprylyl Glycol, Potassium Sorbate, Hexylene Glycol

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