Otc - Active Ingredient
Zinc Oxide 19%
Shiny Hiny Spf 45 Mineral Sunscreen Lotion
FDA Label NDC 85465-045
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shiny Hiny Products, Llc for the product Shiny Hiny Spf 45 Mineral Sunscreen (NDC 85465-045). 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, package label.principal display panel, 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 no 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 Center right away.
Dosage & Administration
Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at lease every 2 hours.
For children under 6 months of age: ask a doctor.
Inactive Ingredient
Aloe Barbadensis (Aloe) Leaf Juice*, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Curcuma Longa (Turmeric) Root Extract*, Deionized Water, Diisostearoyl Polyglycery-3 Dimer Dilinoleate, Ethyl Lauroyl Arginate HCl, Extracts of Alaria Esculenta (Wakame Seaweed), Camelia Sinensis (Green Tea) Leaf*, Ocimum Tenuiflorum (Tulsi) Leaf*, Olea Europa (Olive) Leaf* in Cocos Nucifera (Coconut) Oil, Iron Oxides (CI 77492, CI 77491, CI 77499), Isoamyl Laurate, Jojoba Esters, Mica, Mixed Tocopherols, Olive Squalane Oil, Polyglyceryl-3 Oleate, Polyhydroxystearic Acid, Olive Squalane Oil, Polyglceryl-3 Oleate, Polyhydroxystearic Acid, Propanediol, Silica, Sodium Chloride, Sodium Stearoyl Glutamate, Tetrasodium Glutamate Diacetate, Vegetarian Glycerin, Xanthan Gum, *ORGANIC INGREDIENTS
* Please review the disclaimer below.
