Soleil Superieur Body Spf 50 Us
FDA Label NDC 82691-145

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rv Skincare Llc for the product Soleil Superieur Body Spf 50 Us (NDC 82691-145). 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 if, 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%

Homosalate 10.00%

Octisalate 5.00%

Octocrylene 2.60%

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

Directions

• For sunscreen use:
• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply 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 a Broad Spectrum SPF value of 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
• Children under 6 months of age: Ask a doctor

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Aqua (Water, Eau), Ethylhexyl Salicylate, Dipropylene Glycol, Caprylyl Methicone, Dicaprylyl Carbonate, PEG/PPG-17/6 Copolymer, Potassium Cetyl Phosphate, PEG-100 Stearate, Glyceryl Stearate, Methyl Glucose Sesquistearate, Alcohol Denat., Oligopeptide-24, Tocopheryl Acetate, Caprylyl Glycol, Polyacrylate-15, PEG-10 Dimethicone,  Carnosine, Lecithin, Polyacrylate-17, Silybin, Tocopherol, Glycerin, Sodium Oleate, Glycine Soja (Soybean) Oil, Hydrogenated Lecithin, Hexylene Glycol, C11-15 Pareth-7, C11-15 Pareth-40, Parfum (Fragrance), Sodium Laureth-12 Sulfate, Disodium Lauryl Sulfosuccinate, Hydrogenated Palm Glycerides, Cetyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Disodium EDTA, Potassium Sorbate,  Potassium Hydroxide, Citric Acid. 

Questions Or Comments?

Call 1-866-986-7083, M – F 8am – 5pm CST.

Package Labeling:

Box4 (Box4)

Box4 (Box4)

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