PHOTOBLOCK- avobenzone, bis-ethylhexyl hydroxydimethoxy benzylmalonate gel 
Pella Pharmaceuticals Co. Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Photo Gel

Forms and Presentation

Gel: Tube of 75 g.

Active ingredients

Avobenzone

Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate

Inactive Ingredients

Aqua, Alcohol, Glycerin, Isopropyl Myristate, Ceteareth-25, Carbomer, Methylparaben, Triethanolamine, Propylparaben and Disodium EDT A.

Purpose

Sunscreen

Properties

Photoblock ® Gel is a gel sunscreen with a protection factor SPF 50. The Photoblock ® Gel sunscreen is distinguished by its special formula; it is suitable for oily and acne-prone skin, Photoblock ® Gel provides long-term protection during times of peak temperatures during the day.

Indications

Photoblock ® Gel with its protection SPF 50 is recommended for oily and acne-prone skin.

Precautions

Keep out of reach of children

Warnings

Contraindications

Hypersensitivity to any of the components.

Side effects

Photoblock ® Gel has no known side effects, its use is harmless.

Dosage and administration

Apply Photoblock ® Gel before sun exposure and on dry skin, apply a sufficient amount of Photoblock ® Gel and spread it well on the whole area.
Reapply every 2 hours or after swimming or sports.

Storage conditions

Store at a temperature below 30 ° C.

Primary Package

Primary Package

Secondary Package

Secondary Package

PHOTOBLOCK 
avobenzone, bis-ethylhexyl hydroxydimethoxy benzylmalonate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82160-344
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV) (BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE - UNII:7D4Q5YJ8NV) BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE3.75 mg  in 75 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 75 g
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ALCOHOL (UNII: 3K9958V90M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
CETEARETH-25 (UNII: 8FA93U5T67)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82160-344-011 in 1 CARTON07/07/2011
175 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/07/2011
Labeler - Pella Pharmaceuticals Co. Ltd (562370925)

Revised: 11/2021
Document Id: d18a42cb-b736-9c36-e053-2a95a90a25ea
Set id: d18a42cb-b735-9c36-e053-2a95a90a25ea
Version: 344
Effective Time: 20211124
 
Pella Pharmaceuticals Co. Ltd