Broad Spectrum Spf50 Gel
FDA Label NDC 81104-801

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 Broad Spectrum Spf50 (NDC 81104-801). 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%

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.
Skin Cancer/Skin Aging Alert:
Spending time in the sun increases
your risk of skin cancer and early skin
aging. This product has been shown
only to help prevent sunburn, not skin
cancer or early skin aging. 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. Keep out of reach of
children: If product is swallowed, get
medical help or contact a Poison
Control Center right away. Use a
water-resistant sunscreen if swimming
or sweating.

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:
Water, Butyloctyl Salicylate,
Propylene Glycol, Acrylates
Copolymer, Euphorbia Cerifera
(Candelilla) Wax, Phenoxyethanol,
Hydroxyacetophenone,
Acrylates/C10-30 Alkyl Acrylate
Crosspolymer, Glycerin, Tocopheryl
Acetate, Polyacrylate
Crosspolymer-6, Ethylhexylglycerin,
Sodium Hyaluronate, Sodium
Hydroxide, Terminalia Ferdinandiana
(Kakadu Plum) Fruit Extract,
Disodium EDTA, Citric Acid

Other Information

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

* Please review the disclaimer below.