Active Ingredients
Zinc Oxide 20.0%
Baby Mineral Sunscreen Probiotics Spf55 Lotion
FDA Label NDC 73418-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hello Bello for the product Baby Mineral Sunscreen Probiotics Spf55 (NDC 73418-101). 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, do not use on, 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
Warnings
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
- 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
- For children under 6 months of age, ask a doctor
- 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: • Limit time in the sun, especially from 10a.m. - 2p.m. • Wear long-sleeved shirts, pants, hats and sunglasses
Other Information
- Protect the product in this container from excessive heat and direct sun
- Avoid long-term exposure storage above 40°C (104°F)
- May stain some fabrics
Inactive Ingredients
Water (Aqua), Cocos Nucifera (Coconut) Oil*, Butyloctyl Salicylate, Diheptyl Succinate, Methyl Dihydroabietate, Butyrospermum Parkii (Shea) Butter*, Capryloyl Glycerin/Sebacic Acid Copolymer, Sodium Stearoyl Glutamate, Cetearyl Alcohol, Microcrystalline Cellulose, Arachidyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Cetyl Alcohol, Caprylyl Glycol, Coco Glucoside, Behenyl Alcohol, Citrus Aurantium Dulcis (Orange) Peel Oil, Polyhydroxystearic Acid, Bisabolol*, Arachidyl Glucoside, Sodium Gluconate, Sodium Hyaluronate, Citric Acid, Triethyl Citrate, Glycerin, Caprylhydroxamic Acid, Cellulose Gum, Vanilla Planifolia Fruit Extract, Prunus Armeniaca (Apricot) Kernel Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Chamomilla Recutita (Matricaria) Flower Extract*, Avena Sativa (Oat) Kernel Oil, Bacillus Ferment, Persea Gratissima (Avocado) Fruit Extract*, Calendula Officinalis Flower Extract*, Cucumis Sativus (Cucumber) Fruit Extract*
*Organic
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