Forms And Presentation
Cream: Tube of 75 g.
Photoblock Plus
FDA Label NDC 82160-276
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 Photoblock Plus (NDC 82160-276). 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 forms and presentation, active ingredients, inactive ingredients, purpose, properties, indications, contraindications, precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Avobenzone
Titanium Dioxide
Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate
Inactive Ingredients
Aqua, Glycerin, Isopropyl Myristate, Cetearyl Alcohol, Ceteareth-22, Glyceryl Stearate, Disodium Phosphate, Citric Acid, Methylparaben, Propylparaben and BHA.
Purpose
Sunscreen
Properties
Photoblock
® Plus Cream is a sunscreen and anti-aging cream. which is characterized by its maximum protection SPF 50 + (recognized by global health authorities and scientists) that protects against UVA and UVB.
Photoblock
® Plus Cream does not cause acne and will not clog pores. Photoblock
® Plus Cream provides sustained protection during peak daytime temperature.
Indications
Photoblock
® Plus Cream is used to provide maximum sun protection while maintaining a youthful and radiant skin.
Photoblock
® Plus Cream protects the skin against premature aging caused by exposure to UVA due to its components Ronacare AP and Parsol 1789 (A vobenzone ), the only substances approved by the American FDA "Food and Drug Administration", which provide complete protection against UVA. It also contains Titanium Dioxide which provides protection against UVB rays that cause redness and burns.
Contraindications
Hypersensitivity to any of the components.
Precautions
- Keep out of reach of children
Warnings
- For external use only
- Avoid conact with eyes
Side Effects
Photoblock ® Plus Cream has no known side effects, its use is harmless.
Dosage And Administration
Apply Photoblock
® Plus Cream about 15 minutes before sun exposure. Apply Photoblock
® Plus Cream on intact skin, apply a sufficient amount and massage gently.
Reapply every 2 hours or after swimming or sports.
Storage Conditions
Store at a temperature below 30 ° C.
* Please review the disclaimer below.
