Allswell Mineral Sunscreen Spf 30 Lotion
FDA Label NDC 69555-043

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Stream2sea, Llc for the product Allswell Mineral Sunscreen Spf 30 (NDC 69555-043). 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 ingredient, purpose, uses, warnings, directions, inactive ingredients, other information, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Zinc Oxide 22%

Purpose

Sunscreen

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.

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

Directions

  • Apply liberally 15 minutes before sun exposure, reapply after 80 minutes of swimming or sweating, immediately after towel drying, at least every two 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 value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10am – 2pm
    • wear long-sleeve shirts, pants, hats and sunglasses
    • Children under 6 months: Ask a doctor 

Inactive Ingredients

Helianthus Annus (Sunflower) Seed Oil, Persea Gratissima (Avocado) Oil, Caprylic Capric Triglycerides, Butyrospermum Parkii (Shea) Butter, Beeswax, Helianthus Annus (Sunflower) Seed Wax, Polyhydroxystearic Acid, Glyceryl Caprylate (and) Glyceryl Undecylenate, Non-GMO Corn Starch, Acrylates Copolymer, Vitamin E

Other Information

  • Protect this product from excessive heat and direct sun

Questions Or Comments?

  • Visit allswellgoods.com

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