FDA.reportPublic FDA data

Photoblock Plus

Manufacturer
Pella Pharmaceuticals Co. Ltd
Effective date
2021-11-24
Label type
HUMAN OTC DRUG LABEL
Version
276
Source
full-release
Hydrated at
2026-05-31 23:45:11

Label at a glance#

ProductPhotoblock Plus
Active ingredientAVOBENZONE, TITANIUM DIOXIDE, BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE
Label structure14 sections

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 and handling

Store at a temperature below 30 ° C.

Label contents#

Full prescribing information#

Forms and Presentation

HOW SUPPLIED SECTION

Cream: Tube of 75 g.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone

Titanium Dioxide

Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Sunscreen

Properties

DESCRIPTION SECTION

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

INDICATIONS & USAGE SECTION

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

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 conact with eyes

Side effects

ADVERSE REACTIONS SECTION

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

Dosage and administration

DOSAGE & ADMINISTRATION SECTION

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

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
82160-276-01Photoblock Plus75 g in 1 TUBECREAM75276
82160-276-01Photoblock Plus1 in 1 CARTONCREAM1276

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82160-276PHOTOBLOCK PLUS (AVOBENZONE, TITANIUM DIOXIDE, BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE) CREAM [PELLA PHARMACEUTICALS CO. LTD]276Legacy NDC, 2 package rows20211130_d189a85e-9537-5d8b-e053-2a95a90ac409.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82160-27682160-276-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
AVOBENZONEG63QQF2NOXACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
CETEARETH-2228VZG1E234IACT
BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE7D4Q5YJ8NVACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
BUTYLATED HYDROXYANISOLEREK4960K2UIACT

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
d189a85e-9538-5d8b-e053-2a95a90ac409d189a85e-9537-5d8b-e053-2a95a90ac4092021-11-24Warnings, Adverse reactionsExact identifier
spl id: d189a85e-9538-5d8b-e053-2a95a90ac409
spl set id: d189a85e-9537-5d8b-e053-2a95a90ac409

Reported adverse events (FAERS/openFDA)#

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