Otc - Active Ingredient
Active ingredients Purpose
Homosalate 8% Sunscreen
Octisalate 4% Sunscreen
Octinoxate 3% Sunscreen
Octocrylene 2% Sunscreen
Moisturising Sunscreen
FDA Label NDC 42315-672
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eshu Pty Ltd for the product Moisturising Sunscreen (NDC 42315-672). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, 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
Otc - Purpose
Uses
-Helps prevent sunburn
-higher SPF gives more sunburn protection
-provides high protection against sunburn
-for skin highly sensitive to sunburn
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Indications & Usage
-Stop use and ask a doctor if rash or irritation occurs. -Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce risk of skin aging, skin cancer, and other harmful effects of the sun-Does not provide protection for already burnt skin-every case of sunburn damages the skin permanently -does not provide 100% protection against UV radiation-store in a cool dry place-keep carton. It contains important information
Warnings
warnings
For external use only
When using this product keep out of eyes. rinse with water to remove
If swallowed, get medical help or call a poison control center right away
Dosage & Administration
Directions-apply liberally and generously onto clean, dry skin and rub in evenly 20 minutes prior to sun exposure-apply enough to give a visible layer before rubbing in .-re-apply as needed every 1-2 hours, or after towel drying, swimming, or perspiring.-Children under 6 years of age: ask a doctor.
Inactive Ingredient
Inactive ingredients
Allantoin, Ammonium Acryloyldimethicone/VP copolymer, Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Cetyl Dimethicone, Cylcomethicone, Disodium EDTA, Ethyl Linoleate, Fragrance, Isostearyl Neopentoate, Lactic Acid, Glycerin, Peg-40 Stearate, Polypropylene, Xanthan gum, Octanohydroxamic acid, Oleyl Alcohol, Panthenol, Panthenyl Triacetate, Pentylene Glycol, Serine, Silica, Sodium chloride, Sodium Lactate, Sorbitol, Tocopherol, Triacontanyl PVP, Urea, water.
Image Of Back Label (Back)
Package Label.Principal Display Panel
Moisturizing Sunscreen SPF 30+
100 mL/3.4 oz
Image Of Front Panel (Front)
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