Costa Sea Mineral Sunscreen Spf 50 Cream
FDA Label NDC 85045-558

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Costa Sea Inc for the product Costa Sea Mineral Sunscreen Spf 50 (NDC 85045-558). 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, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Zinc Oxide 17.50

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 store it at temperatures above 120°F.

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 a 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 10 a.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

Adansonia Digitata Oil, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Daucus Carota Sativa (Carrot) Seed Extract, Decyl Glucoside, Dodecane, Glycerin, Glyceryl Caprylate, Glyceryl Stearate SE, Glyceryl Undecylenate, Mangifera Indica (Mango) Seed Butter, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Propanediol, Punica Granatum Fruit Extract, Sodium Stearoyl Glutamate, Stearic Acid, Tocopherol, Tridecyl Salicylate, Vaccinium Angustifolium (Blueberry) Fruit Extract, Water (Aqua), Xanthan Gum

Questions?

+1 (813) 647-5251

Package Labeling:

Package (Package)

Package (Package)

* Please review the disclaimer below.