Otc - Active Ingredient
Active Ingredients
Titanium Dioxide................4.31%
Zinc Oxide .......................19.27%
Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen Spf 30 Paste
FDA Label NDC 65278-619
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by June Jacobs Labs, Llc for the product Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen Spf 30 (NDC 65278-619). 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, warnings, otc - do not use, otc - when using, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
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 aging cause by the sun.
Warnings
Warnings For external use only
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
• Apply liberally 15 minutes before sun exposure
• Reapply every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• Children under 6 months 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 a.m.- 2 p.m.
• wear long sleeved shirts, pants, hats and sunglasses
Other Safety Information
Other information • Protect the product in this container from excessive heat and direct sun
Inactive Ingredient
Inactive ingredients
Ethyl Macadamiate, Caprylic/Capric Triglyceride, Saccharomyces Ferment, Coco-Caprylate/Caprate, Behenyl Behenate, Sorbitol/ Sebacic Acid Copolymer Behenate, Polyhydroxystearic Acid, Octyldodecyl Erucate, Euphorbia Cerifera (Candelilla) Wax, Fragrance/Parfum, Lauroyl Lysine, Iron Oxides, Stearic Acid, Alumina, Glyceryl Caprylate, Butyrospermum Parkii (Shea) Butter, Persea Gratissima (Avocado) Oil , Argania Spinosa Kernel Oil, Tocopheryl Acetate, Polyglyceryl-6 Polyricinoleate, Dilinoleic Acid/Butanediol Copolymer, Tocopherol, Glyceryl Undecylenate, Malic Acid, Castor Oil/IPDI Copolymer, Glycerin, Lycium Barbarum Fruit Extract , Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract , Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Limonene, Linalool, Citral.
Otc - Questions
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