Active Ingredients
Zinc Oxide 21%
Elaine Sterling Hydrating Sunscreen Cream
FDA Label NDC 87702-409
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Elaine Sterling Enterprises for the product Elaine Sterling Hydrating Sunscreen (NDC 87702-409). 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, otc - keep out of reach of children, directions, inactive ingredients, 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
Uses
Helps protect against sunburn
• Higher SPF gives more sunburn protection. Provides moderate protection against sunburn.
Warnings
Warnings
◦ Do not use on damaged or broken skin
◦ When using this product keep out of eyes. Rinse with water to remove
◦ Stop use and ask doctor if rash occurs
Otc - Keep Out Of Reach Of Children
◦ Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center
Directions
Directions
Apply generously and evenly 15 minutes before so exposure. Children under 6 months of age: Ask a docto 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 am - 2am
Wear long-sleeved shirts, pants, hats and sunglasses
Reapply at least every 2 hours sweating
Use a water-resistant sunscreen if swimming or sweating
Inactive Ingredients
C12-15 Alkyl Benzoate, Polyhdroxysteric Acid, Isostearic Acid, Coco Caprylate/Caprate, PPG-2, Myristyl Ether Propionate, Glycerin, Stearing Acid, Butylene Glycol, Cetyl Alcohol, Cyclopentasiloxane , Ethyl Macadamiate, Lysophosphatidic Acid, Myristoyl Pentapeptide-17, Panthenol, Sodium Hyaluronate, Allantoin, Sodium PCA, Tocopheryl Linoleate/Oleate, Prunus Persica (Peach) Kernal Oil, Corylus Avellana (Hazel) Seed Oil, Rosa Canina Fruit Oil, Potassium Cetyl Phosphate, Aloe Barbadensis Leaf Juice, Avena Sativa (Oat) Straw Extract, Citrus Aurantium, Dulcis (Orange) Peel Extract, Rosa Canina Fruit Extract, Magnesium, Aspartate, Zinc Gluconate, Propanediol, Magnesium Ascorbyl Phosphate, Avena Sativa (Oat) Kernal Flour, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Polysorbate 60, Xanthan Gum, Sodium Chloride, Polyaminopropyl Biguanide, Iron Oxides
Package Label.Principal Display Panel
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