Form And Presentation
Cream-Gel: Plastic Tube, 50 g
Derma Pella Sunscreen Advance Cream-gel Cream
FDA Label NDC 82160-726
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pella Pharmaceuticals Co. Ltd for the product Derma Pella Sunscreen Advance Cream-gel (NDC 82160-726). 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 form and presentation, active ingredients, inactive ingredients, purpose, properties, indications, precautions, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Octocrylene, Butyl Methoxydibenzoylmethane (Avobenzone), Ethylhexyl Salicylate, Phenylbenzimidazole Sulfonic Acid, Polysilicone-15, Titanium Dioxide
Inactive Ingredients
Aqua, Butylene Glycol Dicaprylate/Dicaprate, Potassium Cetyl Phosphate, Silica, Diisopropyl Sebacate, Butylene Glycol, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Behenyl Alcohol, Tromethamine, VP/Hexadecene Copolymer, Phenoxyethanol, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Ethylhexylglycerin
Purpose
Sunscreen
Properties
This product is developed to be suitable for all types of skin, with high sun protection factors (SPF 50 +) and optimum combination of UVB/UVA filters, they efficiently protect the skin pigmentation spots and skin ageing.
It is fast absorbing with dry touch and matte feel for optimal protection without leaving any white residue on skin.
Paraben Free, Water resistant.
Indications
Sunscreen for all skin types
Precautions
Keep out of reach of children
Warnings
- If irritation occurs, immediately rinse with water and discontinue use.
- If irritation persists, consult with a physician.
- Keep away from your eyes, in case of eye contact, flush with water.
- For external use only.
Contraindications
Hypersensitivity to any of the components.
Side Effects
There are no known side effects.
Dosage And Administration
Apply a sufficient amount of the sunscreen about 15 minutes before sun exposure on intact skin and massage gently. Reapply every 2 hours, after swimming, or sport.
Storage Conditions
Store below 30 ◦C.
* Please review the disclaimer below.
