Seven Minerals Skin Friendly Spf 30 Lotion
FDA Label NDC 73609-220

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Seven Minerals Na Llc for the product Seven Minerals Skin Friendly Spf 30 (NDC 73609-220). 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, 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 Ingredients

Avobenzone 3.00%, Octisalate 5.00%, Octocrylene 5.00%

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.

Stop Use And Ask A Doctor

  • if rash or irritation develops and lasts.

Keep Out Of Reach Of Children.

  • If product is swallowed, get medical attention or contact poison control center immediately.

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 sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: • Limit time in the sun, especially between 10am and 2pm. • Wear long sleeve shirts, pants, hats and sunglasses.

Other Information:

• Protect this product from excessive heat and direct sunlight.

Inactive Ingredients:

Acrylates Copolymer, *Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Amodimethicone, Aqua (Deionized Water), Bis Vinyl Dimethicone/ Dimethicone Copolymer, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Olivate, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Cyclopentasiloxane, Daucus Carota Sativa (Carrot) Extract, Glycerin, Glyceryl Caprylate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Magnesium Chloride, Magnesium Sulfate, Mangifera Indica (Mango) Butter, Polysorbate-20, Sodium Hydroxide, Sorbitan Olivate, Stearic Acid, Tocopherol (Vitamin E), Zemea (Corn) Propanediol.

Package Labeling:

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* Please review the disclaimer below.