PHOTOBLOCK- avobenzone, bis-ethylhexyl hydroxydimethoxy benzylmalonate gel

Photoblock by

Drug Labeling and Warnings

Photoblock by is a Otc medication manufactured, distributed, or labeled by Pella Pharmaceuticals Co. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• For external use only
• Avoid contact with eyes

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

Secondary Package

INGREDIENTS AND APPEARANCE

PHOTOBLOCK 
avobenzone, bis-ethylhexyl hydroxydimethoxy benzylmalonate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82160-344
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV) (BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE - UNII:7D4Q5YJ8NV)	BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE	3.75 mg  in 75 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 75 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82160-344-01	1 in 1 CARTON	07/07/2011
1		75 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/07/2011

Labeler - Pella Pharmaceuticals Co. Ltd (562370925)