Active Ingredients
Zinc Oxide 20.0%
Baby Mineral Sunscreen Spf55 Lotion
FDA Label NDC 73418-100
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 Spf55 (NDC 73418-100). 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
- 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
- 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:
- Limiting time in the sun, especially from 10a.m. - 2p.m.
- Wearing long-sleeved shirts, pants, hats and sunglasses
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 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
Package Label.Principal Display Panel
Hellobello_sunscreen_dieline_109c_march2022_ao (Hellobello Sunscreen Dieline 109c March2022 Ao)
* Please review the disclaimer below.
