Solmate
FDA Label NDC 58443-0104

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prime Enterprises, Inc. for the product Solmate (NDC 58443-0104). 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 principal display panel - 177 ml  bottle label, active ingredients, purpose, uses, warnings, otc - when using, otc - stop use, otc - 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

Principal Display Panel - 177 Ml  Bottle Label

Principal Display Panel (88 mL Bottle Label)

Principal Display Panel (88 mL Bottle Label)

SOL

MATE

Love the Sun

SUNSCREEN LOTION

8

BROAD SPECTRUM SPF 8

WATER RESISTANT (80 MINUTES)

SHEER NON-GREASY FORMULA

6 FL.OZ/ 177mL

Active Ingredients

Avobenzone 1%, Octisalate 3%, Octocrylene 0.85%, and Oxybenzone 1%

Purpose

Sunscreen

Uses

  • helps prevent sunburn

Warnings

Skin Cancer/ Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. this product has been shown only to prevent sunburn, not skin cancer or early skin aging.

Otc - When Using

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

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

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 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 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-sleeve shirts, pants, hats, and sunglasses
      • children under 6 months: Ask a doctor

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Fragrance (Parfum), Hydroxypropyl Methylcellulose, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Polyethylene, Polysorbate 20, Propylene Glycol, Propylparaben, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

Other Information

  • protect this product from excesive heat and direct sun

Questions Or Comments?

Biocycle Laboratories, Inc.

16363 NW 49 Avenue, Miami, FL, 33014

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