Active Ingredients
Zinc Oxide 22.1 %
Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum Spf50 Bronze 8g Stick
FDA Label NDC 81104-104
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 Bronze 8g (NDC 81104-104). 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, uses, dosage & administration, warning, inactive ingredients, other information:, otc - questions, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
SPF Product
Dosage & Administration
Directions: Shake well before use.
Apply liberally and reapply every 80 minutes,
especially after swimming or towel drying.
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 am-2 pm Wear longsleeved
shirts, pants, hats, and sunglasses For
Children under 6 months of age ask a doctor.
Warning
Warnings: For external use only. Do not use
on damaged or broken skin Avoid prolonged
sun exposure. If it gets in your eyes, wash well
with water. 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.
Inactive Ingredients
INACTIVE INGREDIENTS: Bis-Diglyceryl Polyacyladipate-2, Butylene Glycol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Coco-Caprylate/Caprate, Cocos Nucifera (Coconut) Oil, Dextrin Palmitate, Diisostearyl Malate, Ethylhexyl Methoxycrylene, Ethylhexyl Palmitate, Euphorbia Cerifera (Candelilla) Wax, Hexylene Glycol, Iron Oxides, Isostearic acid, Mica, Ozokerite, Palmitoyl Hexapeptide‐12, Pentaerythrityl Tetraisostearate, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Phenyl Trimethicone, Polyglyceryl-3 Polyricinoleate, Propylene Carbonate, Silica, Silica Dimethyl Silylate, Sodium Hyaluronate, Stearalkonium Hectorite
Other Information:
Other Information: Protect this product
from excess heat and direct sun. Store below
30°C / 86°F.
Otc - Questions
Questions: [email protected]
Indications & Usage
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.
Otc - Keep Out Of Reach Of Children
Warnings: For external use only. Do not use
on damaged or broken skin Avoid prolonged
sun exposure. If it gets in your eyes, wash well
with water. 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.
* Please review the disclaimer below.
