Otc - Active Ingredient
Active Ingredients Purpose
Avobenzone 3.0% sunscreen
Homosalate 10.0% sunscreen
Octisalate 2.6% sunscreen
octocrylene 2.4% sunscreen
Oxybenzone 5.0% sunscreen
Sun Protection Emulsion Face
FDA Label NDC 59614-221
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Juvena Gmbh for the product Sun Protection Emulsion Face (NDC 59614-221). 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
- Helps prevent sunburn
- for skin that burns easily
-provides moderate protection against sunburn
-higher SPF gives more sunburn protection
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. Do not use on infants under 6 months of age.
Indications & Usage
Stop use and ask a doctor if rash or irritation develops and lasts.
Warnings
when using this product keep out of eyes.
rinse with water to remove.
Dosage & Administration
Apply daily after cleansing and toning .
Smooth over face and throat.
Apply evenly before sun exposure.
Reapply as needed or after towel drying, swimming or perspiring.
Inactive Ingredient
Water (Aqua), Caprylyl Methicone, Hexyldecanol, Dimethicone, Polyglyceryl-3 Methylglucose Distearate, Undercrylene Dimethicone, Aluminum Starch Octenylsuccinate, Steareth-21, Octyldodecyl Olivate, Cetyl Alcohol, Silica, Glycerin, Glycoproteins, Panax Ginseng Root Extract*, Equisetum Arvense (Horsetail) Extract*, Sodium Hyaluronate, Corallina Officinalis Extract, Sea Water ( Maris Aqua), Algae Extract, Aloe Barbadensis Leaf Juice, Steareth-2, Ethylhexyl Glycerin, Disodium EDTA, Benzylidene Dimethoxydimethylindanone, sodium hydroxide, porphyra Umbilicalis Extract, Squalane, Carbomer, Potassium Sorbate, Hydroxyethyl acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Palmaria Pakmata Extract, Tocopheryl Acetate, Diethylhexyl Syringyldenemalonate, Pelvetia Canaliculata Extract, Polysorbate 60, Lecithin, Caprylic/ Capric Triglyceride, Sodium Lactate, Caprylyl Glycol, Alcohol, Benzyl Alcohol, Fragrance ( parfum), Phenoxyethanol, Chlorphenesin, Sodium Benzoate, Methylparaben, Ethylparaben, Propyparaben
Image Of Back Label (Back)
Package Label.Principal Display Panel
Sun protection emulsion face SPF 30125mL/ 4.2 FL. OZ.
* Please review the disclaimer below.
