Maui Island Secret Browning Creme Broad Spectrum Sunscreen Spf 5 Cream
FDA Label NDC 82086-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Formula 7venz L.l.c. for the product Maui Island Secret Browning Creme Broad Spectrum Sunscreen Spf 5 (NDC 82086-003). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Zinc Oxide 3%
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 aging caused by the sun.
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 doctor if rash or irritation develops or lasts.
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
• Apply liberally 15 minutes before sun exposure
• Reapply: After 80 minutes of swimming or sweating
· immediately after towel drying · at least every 2 hours
• 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 broad spectrum SPF of 15 or higher and other sun protection measures including: · Limit time in the sun, especially from 10
a.m.-2 p.m. · Wear long sleeve shirts, pants, hats, & sunglasses
• Children under 6 months: Ask a doctor
Other Information
• Protect this product from excessive heat and direct sun.
Inactive Ingredients
Water, Coco-Caprylate/Caprate, Isoamyl Laurate, Glycerin, Propanediol, Shea (Butyrospermum Parkii) Butter, Jojoba (Simmondsia Chinensis) Seed Oil, Polyglyceryl-6 Stearate, Polyglyceryl-6 Behenate, Aloe Barbadensis Leaf Extract, Rose (Rosa Damascena) Flower Oil, Coffee (Coffea Arabica) Seed Oil, Green Tea (Camellia Sinensis) Leaf Extract, Sphingomonas Ferment Extract, Pongamia Pinnata Seed Extract, Xanthan Gum, Cetyl Alcohol, Silica, Lecithin, Sclerotium Gum, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Pullulan, Titanium Dioxide, Iron Oxides (Cl 77492), Iron Oxides (Cl 77491), Iron Oxides (Cl 77499), Caprylic/Capric Triglyceride, Disteardimonium Hectorite, Isopropyl Titanium Triisostearate, 1,2-Hexanediol, Fragrance, Caprylyl Glycol, Phenoxyethanol, Ethylhexylglycerin
Questions?
(866) MAUITAN | (866) 628-4826
Packaging
Maui Island Secret Browning Creme (82086003 3)
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