Otc - Active Ingredient
Zinc Oxide 20%
Hiya Kids Spf 40 Mineral Sunscren Paste
FDA Label NDC 85447-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hiya Health Products Llc for the product Hiya Kids Spf 40 Mineral Sunscren (NDC 85447-001). 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 - keep out of reach of children, dosage & administration, inactive ingredient, hiya kids mineral sunscreen package label, 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
Helps prevent sunburn.
Warnings
For external use only.
Do not use on damaged or broken skin.
Stop use and ask a doctor if rash occurs.
When using this product keep out of eyes. Rinse with water to remove.
Otc - Keep Out Of Reach Of Children
If product is swallowed, get medical help or contact a Poison Control Ceenter immediately.
Dosage & Administration
Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.
For 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 am - 2 pm. Wear long-sleeved shirts, pants, hats, and sunglasses.
Inactive Ingredient
Cera Alba (Beeswax), Extracts of Calendula Officinalis (Marigold) Flower*, Melissa Officinalis (Lemon Balm) Leaf* and Pantago Lanceolata (Plantain) Leaf in Healianthus Annuus (Sunflower) Seed Oil, Jojoba Esters, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Silica, Sorbitan Olivate, Squalan (Plant-Based) *Certified Organic Ingredients.
* Please review the disclaimer below.
