Sunny Sailor Captain S Classic Clear Mineral Sunscreen Spf 40 Cream
FDA Label NDC 85135-577

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sunny Sailor Llc for the product Sunny Sailor Captain S Classic Clear Mineral Sunscreen Spf 40 (NDC 85135-577). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Zinc Oxide 22.50%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

  • Higher SPF gives more sunburn protection

  • Retains SPF after 80 minutes of swimming or sweating

  • 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.
  • Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°.

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.

If Pregnant Or Breast-Feeding,

ask health professional before use.

Directions

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • 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 the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10a.m.- 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Beeswax*, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract*, Chamomila Recutita (Matricaria) Flower Extract*, Helianthus Annuus (Sunflower) Seed Oil*, Hippophae Rhamnoides Oil*, Olea Europea (Olive) Fruit Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Tocopheryl Acetate.

* Indicates Certified Organic Ingredients

Questions

(954) 466-1933

Package Labeling:

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