Sett Mineral Sunscreen Spf 50
FDA Label NDC 83478-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sett Surf, Ltd. for the product Sett Mineral Sunscreen Spf 50 (NDC 83478-000). 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, do not use, stop use and ask a doctor, when using this product, 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) 12.5%

Titanium Dioxide (non-nano) 4.5%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn
  • If used as directed with othe 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.

Stop Use And Ask A Doctor

if rash occurs.

When Using This Product

keep out of eyes. Rinse with water to remove.

Keep Out Of Reach Of Children.

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

Directions

• Shake well before use • Apply liberally to all exposed skin 15 minutes before sun exposure • 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 increaases 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 measres including: • Limit time in the sun, especially between 10am and 2pm • Wear long-sleeved shorts, pants, hats and sunglasses • For children under 6 months of age - ask a doctor.

Other Information

Store below 90°F / 30°C

Inactive Ingredients

Aqua, Glycine Max (Soybean) Oil, Hydroxy Ethyl Cellulose (Cellulose Gum), Xanthan Gum, Glycerol Mono Stearate, Barium Sulphate, Cetearyl Alcohol, Glycerin, Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Hydrogenated Castor Oil, Copernicia Cerifera (Carnauba) Wax, Sodium Benzoate, Potassium Sorbate, Potassium Cetyl Phosphate, Cucumber Potpourri, Citrullus Vulgaris (Kalahari Melon) Oil, Simmondsia Chenensis (Jojoba) Oil, Argania Spinosa (Argan) Oil, Aloe Vera Extract, Ascorbic Acid (Vitamin C), Tocopherol Acetate (Vitamin E).

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