Active Ingredients
ZINC OXIDE 7.0%
TITANIUM DIOXIDE 3.0%
Pelle Wellness Spf 50 Face And Body Broad Spectrum Mineral Sunscreen
FDA Label NDC 83625-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pelle Wellness Llc for the product Pelle Wellness Spf 50 Face And Body Broad Spectrum Mineral Sunscreen (NDC 83625-101). 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, purpose, uses, warnings, otc - keep out of reach of children, directions, storage and handling, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
SUNSCREEN
Uses
- Helps prevent sunburn
- If used as directed
- Decreases the risk of skin cancer and early signs of aging caused by the sun
Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
- 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 occurs.
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 generously and evenly 15 minutes before sun exposure
- Reapply after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- Use a water-resistant sunscreen if swimming.
Children after 6 months: Ask a doctor
Storage And Handling
- Protect this product from excessive heat and direct sun.
Inactive Ingredients
Water, Glycerin, Ethylhexyl Palmitate, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Propanediol, Sodium PCA, Glyceryl Stearate, PEG-100 Stearate, Polysorbate 60, Cetyl Alcohol, Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Citric
Acid, Sodium Citrate, Glyceryl Caprylate, Caprylyl Methicone, Alumina, Xanthan Gum, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Chlorphenesin, Cyclotetrasiloxane, Allantoin, Polyhydroxystearic Acid,
Triethoxycaprylylsilane, Glyceryl Undecylenate, 1,2-Hexanediol, Caprylyl Glycol, Disodium EDTA, Panthenol, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Euterpe Oleracea Fruit Extract, Sodium Hyaluronate, Phenoxyethanol
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