FDA.reportPublic FDA data

Photoblock

Manufacturer
Pella Pharmaceuticals Co. Ltd
Effective date
2021-11-24
Label type
HUMAN OTC DRUG LABEL
Version
221
Source
full-release
Hydrated at
2026-05-31 23:45:11

Label at a glance#

ProductPhotoblock
Active ingredientTITANIUM DIOXIDE, AVOBENZONE
Label structure14 sections

Dosage and administration

Before sun exposure, apply a sufficient quantity on skin and massage gently. Reapply every 2 hours or after swimming or sports.

Storage and handling

Store at a temperature below 30 ° C.

Label contents#

Full prescribing information#

Forms and Presentation

HOW SUPPLIED SECTION

Cream: Tube of 150 g.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone

Titanium Dioxide

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, Cetearyl Alcohol, Ceteareth-22, lsopropyl Myristate, Glyceryl Stearate, Disodium Phosphate, Citric Acid, Methylparaben, Propylparaben and BHA.

Purpose

OTC - PURPOSE SECTION

Sunscreen

Properties

DESCRIPTION SECTION

Photoblock ® Cream is a sunscreen that is characterized by its maximum protection.
Photoblock ® cream doesn't cause acne and doesn't clog the skin pores. Photoblock ® SPF 50+ Cream protects against UV A and UVB, it suits the whole family members.

Indications

INDICATIONS & USAGE SECTION

Photoblock ® cream is used to provide maximum protection as well as youth and freshness.
It contains Titanium Dioxide which is well known as a physical sunscreen that protects against UVB and sun burns, in addition to Avobenzone which provides complete protection against UVA.

Contraindications

CONTRAINDICATIONS SECTION

Hypersensitivity to any of the components

Precautions

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Warnings

WARNINGS SECTION

  • For external use only
  • Avoid contact with eyes

Side effects

ADVERSE REACTIONS SECTION

Photoblock ® Cream has no side effects, its use is harmless.
Preferably used by small children under the supervision of an adult.

Dosage and administration

DOSAGE & ADMINISTRATION SECTION

Before sun exposure, apply a sufficient quantity on skin and massage gently.
Reapply every 2 hours or after swimming or sports.

Storage conditions

STORAGE AND HANDLING SECTION

Store at a temperature below 30 ° C.

Primary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary PackagePrimary Package

Secondary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Secondary PackageSecondary Package

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82160-221-01Photoblock150 g in 1 TUBECREAM150221
82160-221-01Photoblock1 in 1 CARTONCREAM1221

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82160-221PHOTOBLOCK (AVOBENZONE, TITANIUM DIOXIDE) CREAM [PELLA PHARMACEUTICALS CO. LTD]221Legacy NDC, 2 package rows20211130_d1867c62-9af5-1abf-e053-2995a90a3c48.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82160-22182160-221-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
CETEARETH-2228VZG1E234IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
AVOBENZONEG63QQF2NOXACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d1867c62-9af6-1abf-e053-2995a90a3c48d1867c62-9af5-1abf-e053-2995a90a3c482021-11-24Warnings, Adverse reactionsExact identifier
spl id: d1867c62-9af6-1abf-e053-2995a90a3c48
spl set id: d1867c62-9af5-1abf-e053-2995a90a3c48

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.