Sunscreen In The Raw Spf 50 Cream
FDA Label NDC 82177-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Biomin Llc for the product Sunscreen In The Raw Spf 50 (NDC 82177-004). 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 17.50%

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 or irritation develops and lasts.

Keep Out Of Reach Of Children.

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

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 this risk, regularly use a sunscreen with broad-spectrum SPF 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:

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

Questions?

(877) 557-1010

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