Drug Fact
Active ingredient
Octinoxate 7.50%
Octisalate 5.00%
Zinc Oxide 4.90%
Titanium Dioxide 4.15%
Amiloxate 2.00%
The following Structured Product Label (SPL) was submitted to the FDA by Dermaesthetics Inc. for the product Egf Uv Shield (NDC 58831-1001). 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, egf uv shield, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient
Octinoxate 7.50%
Octisalate 5.00%
Zinc Oxide 4.90%
Titanium Dioxide 4.15%
Amiloxate 2.00%
Sunscreen
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 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
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.
Uses
Helps prevent sunburn.
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.
Water, Propylene Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Hydrogenated Poly(C6-14 Olefin), Cetyl PEG/PPG-10/1 Dimethicone, PEG-10 Dimethicone, Betaine, Disteardimonium Hectorite, Magnesium Sulfate, Sorbitan Sesquioleate, Aluminum Hydroxide, Stearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Methyl Methacrylate Crosspolymer, Triethoxycaprylylsilane, Portulaca Oleracea Extract, Poncirus Trifoliata Fruit Extract, Tocopheryl Acetate, Sorbitan Isostearate, Squalane, Simmondsia Chinensis(Jojoba) Seed Oil, Macadamia Ternifolia Seed Oil, Diospyros Kaki Leaf Extract, Cinnamomum Cassia Bark Extract, Artemisia Princeps Leaf Extract, Chrysanthellum Indicum Extract, Chaenomeles Sinensis Fruit Extract, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Juice, Chamomilla Recutita(Matricaria) Flower Extract, Lecithin, Sorbitol, Xanthan Gum, Glyceryl Linoleate, Glyceryl Linolenate, rh-Oligopeptide-1, Acetyl Hexapeptide-8, Sodium Ascorbate, Retinyl Palmitate, Phenoxyethanol, Methylparaben, Propylparaben, Butylparaben, Fragrance
* Please review the disclaimer below.