Active Ingredient
Zinc Oxide
Fhf Elevated Shade 100% Mineral Sunscreen Lotion
FDA Label NDC 59958-601
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Owen Biosciences Inc for the product Fhf Elevated Shade 100% Mineral Sunscreen (NDC 59958-601). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask doctor, 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
Provides moderate protection against sunburn
Warnings
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 docctor if rash occurs
Keep out of reach of children. If swallowed, get medical help or contact Poison Control.
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 Doctor
if rash occurs
Keep Out Of Reach Of Children
If swallowed get medical help or contact Poison Control
Directions
Apply generously and evenly 15 minutes before sun exposure
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 decreasse 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 especialy from 10a.m. - 2 p.m.
Wear long-sleeve shirts, pants, hats, and sunglasses
Reapply at least every 2 hours
Use a water-resistant sunscreen if swimming or sweating
Other Information
Protect the product in this container from excessive heat and direct sun
Inactive Ingredients
Water, Caprylic/Capric Triglyceride, Ethyl Macadamiate, Glycerin, Propanediol, Polyglyceryl-3 Polyricinoleate, Triethoxycaprylylsilane, Polyglyceryl-10 Stearate, Cetearyl Olivate, Xanthan Gum, Magnesium Aluminum Silicate, Sodium Hyaluronate, Sodium PCA, Niacinamide, Allantoin, Quercitin, Sodium Ascorbyl Phosphate, Camellia Sinensis Leaf Extract, Sodium Chloride, Glyceryl Isostearate, Polyhydroxystearic, Sorbitan Olivate, Linum Usitatissimum (Linseed) Seed Oil, Tocopherol, Iron Oxides, Triethoxysilylpropyl Acetyl Hydroxyprolinate, Phenoxyethanol, Caprylyl Glycol, Polymethyl Methacrylate, Tromethamine, Pisum Sativum (Dwarf Grey Sugar Pea) Extract, Parfum
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