Collagen Glow Mineral Sunscreen Lotion
FDA Label NDC 81104-103

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 Collagen Glow Mineral Sunscreen (NDC 81104-103). 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 ingredient, 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 Ingredient

ZINC OXIDE 22.75%

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

For external use only.

  • Do not use on damaged or broken skin.
  • When using this product: keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if: rash occurs.
    • CONTAINS SODIUM BENZOATE.

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 GENEROUSLY 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

CETEARYL GLUCOSIDE, CETOSTEARYL ALCOHOL, COCO-CAPRYLATE, DISODIUM EDETATE, GLUCONOLACTONE, HYDROLYZED ADANSONIA DIGITATA SEED EXTRACT, HYDROLYZED RICE PROTEIN, HYDROLYZED SOY PROTEIN, ISOSTEARIC ACID, CAPRIC TRIGLYCERIDES, OCTYLDODECANOL, PEG-30 DIPOLYHYDROXYSTEARATE, POLYGLYCERYL-3 POLYRICINOLEATE, PROLINE, WATER (AQUA), SODIUM BENZOATE, SODIUM CHLORIDE.

Other Information

Protect the product in this container from excessive heat and direct sun.

* Please review the disclaimer below.