Sun Shades
FDA Label NDC 54473-163

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Melaleuca, Inc. for the product Sun Shades (NDC 54473-163). 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 otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, general precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients
Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

Otc - Purpose

Purpose
Sunscreen

Warnings

Warnings
For external use only

Flammable: do not use near heat, flame, or while smoking

Otc - When Using

When using this product

  • keep out of eyes. Rinse with water to remove.
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

Otc - Stop Use

Stop use and ask a doctor if rash or irritation develops and lasts

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • shake well before first use
  • apply evenly and liberally to all exposed areas before sun exposure
  • do not spray directly on face. Spray on hands to apply to face
  • use in well-ventilated area
  • reapply after 80 minutes of swimming or sweating and after towel drying. Otherwise, reapply at least every 2 hours.
  • children under 6 months of age: ask a doctor

General Precautions

  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun
  • may stain some fabrics

Storage And Handling

Other information

  • do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

Inactive Ingredient

Inactive ingredients
acrylates/octacrylamide copolymer, aleurites moluccana seed oil, ascorbyl palmitate, bisabolol, bixa orellana seed extract, C12-15 alkyl benzoate, caprylic/capric triglyceride, disodium lauriminodipropionate tocopheryl phosphate, macadamia ternifolia seed oil, parfum, phenyl trimethicone, polyester-10, propylene glycol dibenzoate, SD alcohol 40-B, tocopherol

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