Otc - Active Ingredient
Zinc Oxide 22.75%
Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum Spf50 Pink Pop 8g Stick
FDA Label NDC 81104-106
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 Glow Balm Mineral Peptide Stick Broad Spectrum Spf50 Pink Pop 8g (NDC 81104-106). 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, indications & usage, otc - keep out of reach of children, dosage & administration, other safety information, warnings, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
SPF Suncscreen
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
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-resistance sunscreen if
swimming or sweating. Children
under 6 months of age: Ask a Doctor
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
10.00AM - 2.00PM Wear
long-sleeved shirts, pants, hats, and
sunglasses.
Warnings
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 skin rash occurs.
Keep out of reach of children. If
product is swallowed, get medical
help or contact a Poison Control
Center right away.
Inactive Ingredient
INACTIVE INGREDIENTS: C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, FD&C Red No. 4 (CI 14700), FD&C Yellow 6 Lake (CI 15985:1), Isostearic Acid, Mica, Microcrystalline Wax, Palmitoyl Hexapeptide-12, Paraffin Wax, Pentaerythrityl Tetraisostearate, Polyglyceryl-3 Polyricinoleate, Propylene Carbonate, Ricinus Communis (Castor) Seed Oil, Stearalkonium Hectorite, Theobroma Cacao (Cocoa) Seed Butter, Tin Oxide, Titanium Dioxide (CI 77891), Tocopheryl Acetate
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