Salt And Stone Tinted Sunscreen Spf 50
FDA Label NDC 71585-138

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Salt And Stone Llc for the product Salt And Stone Tinted Sunscreen Spf 50 (NDC 71585-138). 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, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, 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 Ingredients

Zinc Oxide (Non-Nano) 24. 05%

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.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

When using this product, keep out of eyes. Rinse with water to remove.

Otc - Stop Use

If rash occurs, stop use and see a doctor.

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:
    • After 80 minutes of swimming or sweating,
    • Immediately after towel drying,
    • At least every two ( 2 ) hours.
  • Sun Protection Measures
    Spending time in the sun increases the risk of skin cancer and early skin aging. To decrease the risk, regularly use: a sunscreen with a broad-spectrum SPF of 15 or higher, and sun protection measures including:
    • Limiting 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 excess heat and direct sun.

Inactive Ingredients

Argania Spinosa Kernel Oil, Beeswax,* Bisabolol, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil,* Copernicia Cerifera (Carnauba) Wax,* Helianthus Annuus (Sunflower) Seed Oil,* Iron Oxides, Mica, Silica, Simmondsia Chinensis (Jojoba) Seed Oil,* Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethoxycaprylylsilane.

Package Label

Image Description (Label3)

Image Description (Label3)

* Please review the disclaimer below.