Active Ingredients
ZINC OXIDE 11.0%
Isntree Hyaluronic Acid Sensitive Sunscreen Cream
FDA Label NDC 81100-506
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Isntree Inc. for the product Isntree Hyaluronic Acid Sensitive Sunscreen (NDC 81100-506). 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, 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 • higher SPF gives more sunburn protection
• 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 damaged skin or broken skin.
When Using This Product
• keep out of eyes. Rinse with water to remove.
Stop Use And Ask A Doctor If
•rash or irritation develops and lasts.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact
a Poison Control Center right away.
Directions
■ apply liberally 15 minutes before sun exposure.
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 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
■ children under 6 months of age: Ask a doctor
■ reapply at least every 2 hours.
■ use a water-resistant sunscreen if swimming or sweating.
Other Information
■ protect the product from exessive heat and
direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and
using sunscreens may reduce the risks of skin aging, skin cancer, and other
harmful effects of the sun.
Inactive Ingredients
Water, Propanediol, Butylene Glycol, Caprylic/Capric Triglyceride, Acrylates Copolymer, Butyloctyl Salicylate, Caprylyl Methicone, Polyglyceryl-3 Distearate, Propylene Glycol Dicaprylate/Dicaprate, C12-15 Alkyl Benzoate, 1,2-Hexanediol, Pentylene Glycol, Cetearyl Alcohol, Polyhydroxystearic Acid, Glyceryl Stearate, Panthenol, Dimethicone/Vinyl Dimethicone Crosspolymer, Sodium Polyacryloyldimethyl Taurate, Glycerin, Hydrolyzed Jojoba Esters, Sodium Acrylic Acid/MA Copolymer, Triethoxycaprylylsilane, Glyceryl Stearate Citrate, Polyacrylate Crosspolymer-6, Methylpropanediol, Xanthan Gum, Ethylhexylglycerin, Caprylyl Glycol, Hydrolyzed Hyaluronic Acid, Zinc Hydrolyzed Hyaluronate, Polyether-1, Ceramide NP, Maltodextrin, Hydrolyzed Vegetable Protein, Tocopherol, Biosaccharide Gum-1
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