Solmate
FDA Label NDC 58443-0140

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 58443-0140). 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 - 237 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 - 237 Ml  Bottle Label

Principal Display Panel-237ml Bottle Label (58443 0140 4)

Principal Display Panel-237ml Bottle Label (58443 0140 4)

SOL

MATE

BABY

SUNSCREEN LOTION

50

BROAD SPECTRUM SPF 50

WATER RESISTANT (80 MINUTES)

SHEER NON-GREASY FORMULA

FRAGRANCE FREE

8 FL.OZ./237mL

Active Ingredients

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 3 %

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Dictections), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

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, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Polyethylene, Polysorbate 20, Propylene Glycol, Propylparaben, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water

Other Information

  • protect this product from excesive heat and direct sun

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