Active Ingredients
Zinc Oxide 20.0%
Mineral Sunscreen Spf 50 Lotion
FDA Label NDC 73418-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hello Bello for the product Mineral Sunscreen Spf 50 (NDC 73418-102). 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, for external use only, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., 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 with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
For External Use Only
Do Not Use
on broken or damaged skin
When Using This Product
Keep out of eyes. Rinse with water to remove
Stop Use And Ask A Doctor If
rash occurs
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Shake well before use
Apply liberally and spread evenly by hand 15 minutes before sun exposure
Reapply:
- after 80 minutes of swimming or sweating immediately after towel use
- at least every 2 hours
- Limiting time in the sun, especially from 10a.m. - 2p.m.
- Wearing long-sleeved shirts, pants, hats and sunglasses
Sun Protection Measures
Spending time in the sun can increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
Children under six months: Ask a doctor
Other Information
Protect this product from excessive heat and direct sun
Avoid long-term exposure storage above 40°C (104°F)
May stain some fabrics
Inactive Ingredients
Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol*, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter*, Calendula Officinalis Flower Extract*, Camellia Sinensis (Green Tea) Leaf Extract*, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract*, Citric Acid, Citrus Aurantium Dulcis (Orange) Peel Oil, Coco Glucoside, Cocos Nucifera (Coconut) Oil*, Cucumis Sativus (Cucumber) Fruit Extract*, Diheptyl Succinate, Glycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Persea Gratissima (Avocado) Fruit Extract*, Polyhydroxystearic Acid, Prunus Armeniaca (Apricot) Kernel Oil*, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Triethyl Citrate, Vanilla Planifolia Fruit Extract, Water (Aqua) *Organic
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* Please review the disclaimer below.
