Otc - Active Ingredient
Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 8%
Naked Sundays Face Body Clear Glow Sunstick Spf50 Shimmer Broad Spectrum Spf50 19g Stick
FDA Label NDC 81104-107
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 Naked Sundays Face Body Clear Glow Sunstick Spf50 Shimmer Broad Spectrum Spf50 19g (NDC 81104-107). 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, inactive ingredient, indications & usage, dosage & administration, warnings, otc - keep out of reach of children, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
SUNSCREEN
Inactive Ingredient
INACTIVE INGREDIENTS: Aloe Barbadensis Leaf Extract, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, FD&C Yellow 6 Lake (CI 15985:1), Glycine Soja (Soybean) Oil, Iron Oxides (CI 77491), Mica, Ozokerite, Persea Gratissima (Avocado) Oil, Polyethylene, Titanium Dioxide (CI 77891)
Indications & Usage
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
Dosage & Administration
Directions: Apply liberally and evenly 15 minutes
before sun exposure. Reapply at least every 2
hours or immediately after swimming, sweating or
towel drying. Use a water-resistant sunscreen if
swimming or sweating.
Warnings
Warnings: For external use only. Do not use on
damaged or broken skin. Avoid prolonged sun
exposure. When using this product: Keep out of
eyes. Rinse with water to remove. 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. Stop use and ask a doctor if rashes
occur.
Other Safety Information
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 10AM - 2PM
Wear long-sleeved shirts, pants, hats, and
sunglasses Children under 6 months of age: Ask a
doctor.
Other Information: Protect this product
from excess heat and direct sun. Store below
30°C / 86°F.
Otc - Questions
Questions: [email protected]
* Please review the disclaimer below.
