Clear Glow Broad Spectrum Suncreen Cream
FDA Label NDC 81104-984

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Naked Sundays Pty Ltd for the product Clear Glow Broad Spectrum Suncreen (NDC 81104-984). 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 - keep out of reach of children, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octilsalate 5%

Octocrylene 8%

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
ageing caused by the sun.

Warnings

Warnings: For external use only. Do not use on
damaged or broken skin. Avoid prolonged sun
exposure. If it gets in your eyes, wash well with
water. Keep out of reach of children. Stop use
and ask a doctor if rashes occur. If product is
swallowed, get medical help or contact a Poison
Control Center right away.

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 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE.
  • Reapply after 80 minutes of swimming or sweating.
  • Reapply immediately after towel drying.
  • Reapply at least every 2 hours.
  • Children under 3 years of age: Ask a doctor.

    • 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 10.00AM - 2.00PM
    • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

Inactive Ingredients: Medium Chain
Triglycerides, Ceresin, Dicaprylyl Carbonate,
Butyloctyl Salicylate, Polyethylene, Citrillus Lanatus

Other Information

Other Information: Protect this product
from excess heat and direct sun. Store below
30°C / 86°F.

* Please review the disclaimer below.