Suzanne Organics Tinted Mineral Sunscreen Broad Spectrum Spf 25 - Sand Cream
FDA Label NDC 15435-300

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Slc Skincare for the product Suzanne Organics Tinted Mineral Sunscreen Broad Spectrum Spf 25 - Sand (NDC 15435-300). 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, 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 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 is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally 15 minutes before sun exposure.
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating
  • 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-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Other Information

  • protect this product from excessive heat and direct sun

Inactive Ingredients

Acetyl Tetrapeptide-2, Allantoin, Artemisia Vulgaris Extract, Benzyl Alcohol, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Olivate, Coco-Caprylate, Ethylhexylglycerin, Iron Oxides, Laminaria Digitata Extract, Mixed Tocopherols, Panthenol, Polyhydroxystearic Acid, Saccharide Isomerate, Sorbitan Olivate, Stearyl Octyldodecyl Citrate Crosspolymer, Tetrasodium Glutamate Diacetate, Tocopherol, Water (Aqua), Xanthan Gum, Zingiber Officinale Root Oil.

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