Otc - Active Ingredient
ZINC OXIDE 9.70%
OCTINOXATE 7.00%
OCTISALATE 3.00%
TITANIUM DIOXIDE 1.52%
Elroel Pang Pang Sun Cushion S7 Cream
FDA Label NDC 83154-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Monoglot Holdings Inc. for the product Elroel Pang Pang Sun Cushion S7 (NDC 83154-003). 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, indications & usage, dosage & administration, warnings, otc - keep out of reach of children, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
Helps prevent sunburn
Dosage & Administration
For sunscreen use:
■ apply liberally 15 minutes before sun exposure
■ reapply at least every two hours
■ use a water resistant sunscreen if swimming or sweating
■ 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 a.m. – 2 p.m.
– wear long-sleeved shirts, pants, hats and sunglasses
■ children under 6 months of age: ask a doctor
Warnings
For external use only.
Do not use on damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove.
Stop using and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.
Inactive Ingredient
Aloe Barbadensis Leaf JuiceCyclopentasiloxane, Butylene Glycol, Butyloctyl Salicylate, Caprylyl Methicone, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Niacinamide, Diphenylsiloxy Phenyl Trimethicone, Alcohol Denat., Propylene Glycol Dicaprylate, Sodium Chloride, Silica, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hydroxyacetophenone, Synthetic Beeswax, Disteardimonium Hectorite, Triethoxycaprylylsilane, Dipropylene Glycol, Water, Fragrance, Caprylyl Glycol, Squalane, Tocopheryl Acetate, Propylene Carbonate, Ethylhexylglycerin, Glycerin, Adenosine, Butyrospermum Parkii (Shea) Butter, Xylitylglucoside, Anhydroxylitol, Disodium EDTA, Methyl Diisopropyl Propionamide, Laminaria Japonica Extract, Ulmus Davidiana Root Extract, Aloe Barbadensis Leaf Extract, Viola Mandshurica Flower Extract, Dioscorea Japonica Root Extract, Xylitol, CI 77492, 1,2-Hexanediol, Glucose, Menthyl Lactate, Beeswax, Ethyl Menthane Carboxamide, Glyceryl Stearate, Caprylic/Capric Triglyceride, Hydrogenated Phosphatidylcholine, Calcium Pantothenate, Centella Asiatica Extract, Sucrose Stearate, Stearamidopropyl Dimethylamine Lactate, Phenethyl Alcohol, PEG-100 Stearate, Sodium Ascorbyl Phosphate, Dipotassium Glycyrrhizate, Cetearyl Alcohol, Polyquaternium-67, Pyridoxine HCl, Madecassoside, Madecassic Acid, Asiaticoside, Asiatic Acid
Other Safety Information
Protect the product in this container from excessive heat and direct sunlight
* Please review the disclaimer below.
