Active Ingredients
Zinc Oxide 21%
Fhf Elevated Shade 100% Mineral Sunscreen Lotion
FDA Label NDC 72788-601
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Summer Soles, Llc Dba Farm House Freash Goods for the product Fhf Elevated Shade 100% Mineral Sunscreen (NDC 72788-601). 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 ingredients, otc - purpose, uses, warnings, directions, otc - keep out of reach of children, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Uses
Uses
• Helps prevent sunburn
• Provides moderate protection against sunburn
Warnings
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 doctor if rash occurs
◦ Keep out of reach of children. If swallowed, get medical help or contact Poison Control
Directions
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 od skin cancer and earloy 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 10a.m.-2p.m.
• Wear long sleeve shirts, pants, hats and sunglasses
Reapply at least every 2 hours
Use a water-resistant sunscreen is swimming or sweating
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact Poison
Other Information
Other Information
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
Quercetin
Sodium Ascorbyl Phosphate
Camellia Sinensis Leaf Extract
Sodium Chloride
Glyceryl Isostearate
Polyhydroxystearic
Sorbital Olivate
Linum Usitatissmum (flax) seed oil
Tocopherol
Iron Oxides
Triethoxysilylpropyl Acetyl Hydroxyprolinate
Phenoxyethanol
Caprylyl Glycol
Polymethyl Methacrylate
Tromethamine
Pisum sativum (Dwarf Gray Sugar Pea) Extract
Parfum
Package Label.Principal Display Panel
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