Hydrating Sunscreen Moisturizer Broad Spectrum Spf50 Cream
FDA Label NDC 81104-802

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 Hydrating Sunscreen Moisturizer Broad Spectrum Spf50 (NDC 81104-802). 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

Use:
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, Ethylhexyl
Methoxycrylene, Dimethicone, Potassium
Cetyl Phosphate, Glyceryl Stearate, Sodium
Polyacrylate, Niacinamide, Tocopheryl
Acetate, Hydroxyacetophenone, Sodium
Benzoate, Glyceryl Caprylate, Sodium
Hyaluronate, Disodium EDTA, Citric Acid,
Sodium Hydroxide

Other Information

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

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