Drug Fact
Active ingredient
Octinoxate 7.50%
Octisalate 5.00%
Zinc Oxide 4.90%
Titanium Dioxide 4.15%
Amiloxate 2.00%
Egf Uv Shield
FDA Label NDC 58831-2001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dermaesthetics Inc. for the product Egf Uv Shield (NDC 58831-2001). 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 drug fact, purpose, keep out of reach of children, indication & usage, warning, 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
Purpose
Sunscreen
Keep Out Of Reach Of Children
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.
Indication & Usage
Directions
-Apply generously and evenly 15-20 minutes before sun exposure.
-Use a water resistant sunscreen if swimming or sweating.
-Reapply every 1-2 hours after towel drying, swimming or perspiring.
-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 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-sleeve shirts, pants, hats, and sunglasses
-Children under 6 months: Ask a doctor
Warning
Warnings
Skin Cancer/Skin Aging Alert:
Spending time in the sun increases your risk of skin cancer and early skin aging.
This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
For external use only.
Do not use on damaged or broken skin. If sun irritation develops or increases.
When using this product keep out of eyes. Rinse with water to remove.
Dosage & Administration
for external use only
Inactive Ingredient
Water, Propylene Glycol, Cyclopentasiloxane, Hydrogenated Poly(C6-14 Olefin Polymer), pentylent glycol, Cetyl PEG/PPG-10/1 Dimethicone, PEG-10 Dimethicone, Betaine, Magnesium Sulfate, Disteardimonium Hectorite, Sorbitan Sesquioleate, butylene glycol, Aluminum Hydroxide, Stearic Acid, silica Dimethicone/Vinyl Dimethicone Crosspolymer, Methyl Methacrylate Crosspolymer, caprylyl glycol, tocopheryl acetate, Triethoxycaprylylsilane, Portulaca Oleracea Extract, Poncirus Trifoliata Fruit Extract, Tocopheryl Acetate, jojoba seed oil, ethyhexylglycerin, Aloe Barbadensis Leaf Juice, squalane, sorbitan isostearate, chamomilla recutita (matricaria) flower extract, macadamia ternifolia seed oil, rh-oligopeptide-1, chaenomeles sinensis fruit extract, cinnamomum cassia bark extract, diospyros kaki leaf extract, artemisia princeps leaf extract, sorbitol, camellia sinensis leaf extract, glycerin, chrysanthellum indicum extract, lecithin, glyceryl linoleate, glyceryl linolenate, phenoxyethano, xanthan gum, acetyl hexapeptide-8, sodium ascorbyl phosphate, retinyl palmitate, di-sodium edta, glyceryl caprylate, fragrance
Package Label.Principal Display Panel
Label (Label)
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