Solmate
FDA Label NDC 13630-0075

11 label sections · Submitted to the FDA by Prime Packaging, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prime Packaging, Inc. for the product Solmate (NDC 13630-0075). 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, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

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

Purpose

Sunscreen

Uses

  • helps prevent sunburn

Warnings

Otc - When Using

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

 •Keep away from face to avoid breathing it.

•Contents under pressure-do not puncture or incinerate. Do not store at temperatures above 120°F

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

  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly into face. Spray on hands then apply to face.
  • do not apply in windy conditions
  • use in a well-ventilated area
  • reapply:
  • After 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months: Ask a doctor

Inactive Ingredients

C12-15 Alkyl Benzoate, Fragrance (Parfum), SD Alcohol 40-B (Alcohol Denat.), VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other Information

•protect this product from excessive heat and direct sun

 •may stain fabrics.

Principal Display Panel - 177 Ml Can Label

Principal Display Panel (177mL Can Label)

Principal Display Panel (177mL Can Label)

SOL

MATE

Love the Sun

Continuous Spray

Sunscreen

8

Broad Spectrum SPF 8

Water Resistant (80) Minutes

Non-Greasy Formula

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