FDA.reportPublic FDA data

Derma Pella Sunscreen Advance Cream-Gel

Manufacturer
Pella Pharmaceuticals Co. Ltd
Effective date
2025-01-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:53:25

Label at a glance#

ProductDerma Pella Sunscreen Advance Cream-Gel
Active ingredientENSULIZOLE, TITANIUM DIOXIDE, OCTISALATE, POLYSILICONE-15, OCTOCRYLENE, AVOBENZONE
Label structure14 sections

Dosage and administration

Apply a sufficient amount of the sunscreen about 15 minutes before sun exposure on intact skin and massage gently. Reapply every 2 hours, after swimming, or sport.

Storage and handling

Store below 30 ◦ C.

Label contents#

Full prescribing information#

Form and Presentation

HOW SUPPLIED SECTION

Cream-Gel: Plastic Tube, 50 g

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene, Butyl Methoxydibenzoylmethane (Avobenzone), Ethylhexyl Salicylate, Phenylbenzimidazole Sulfonic Acid, Polysilicone-15, Titanium Dioxide

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Butylene Glycol Dicaprylate/Dicaprate, Potassium Cetyl Phosphate, Silica, Diisopropyl Sebacate, Butylene Glycol, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Behenyl Alcohol, Tromethamine, VP/Hexadecene Copolymer, Phenoxyethanol, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Ethylhexylglycerin

Purpose

OTC - PURPOSE SECTION

Sunscreen

Properties

DESCRIPTION SECTION

This product is developed to be suitable for all types of skin, with high sun protection factors (SPF 50 +) and optimum combination of UVB/UVA filters, they efficiently protect the skin pigmentation spots and skin ageing.

It is fast absorbing with dry touch and matte feel for optimal protection without leaving any white residue on skin.

Paraben Free, Water resistant.

Indications

INDICATIONS & USAGE SECTION

Sunscreen for all skin types

Precautions

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Warnings

WARNINGS SECTION

- If irritation occurs, immediately rinse with water and discontinue use.
- If irritation persists, consult with a physician.
- Keep away from your eyes, in case of eye contact, flush with water.
- For external use only.

Contraindications

CONTRAINDICATIONS SECTION

Hypersensitivity to any of the components.

Side Effects

ADVERSE REACTIONS SECTION

There are no known side effects.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Apply a sufficient amount of the sunscreen about 15 minutes before sun exposure on intact skin and massage gently. Reapply every 2 hours, after swimming, or sport.

Storage Conditions

STORAGE AND HANDLING SECTION

Store below 30 ◦C.

Primary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary PackagePrimary Package

Secondary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Secondary PackageSecondary Package

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82160-726-01Derma Pella Sunscreen Advance Cream-Gel1 in 1 CARTONCREAM12
82160-726-01Derma Pella Sunscreen Advance Cream-Gel50 g in 1 TUBECREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82160-726DERMA PELLA SUNSCREEN ADVANCE CREAM-GEL (OCTOCRYLENE, AVOBENZONE, ETHYLHEXYL SALICYLATE, PHENYLBENZIMIDAZOLE SULFONIC ACID, POLYSILICONE-15, TITANIUM DIOXIDE) CREAM [PELLA PHARMACEUTICALS CO. LTD]22 package rows20250123_fe95fdbf-73df-a587-e053-6394a90a53a0.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82160-72682160-726-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ENSULIZOLE9YQ9DI1W42ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
OCTISALATE4X49Y0596WACTIB
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
POLYSILICONE-15F8DRP5BB29ACTIB
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
DOCOSANOL9G1OE216XYIACT
HEXADECYL POVIDONEAG75W62QYUIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DIISOPROPYL SEBACATEJ8T3X564IHIACT
OCTOCRYLENE5A68WGF6WMACTIB
XANTHAN GUMTTV12P4NEEIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TROMETHAMINE023C2WHX2VIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE7D4Q5YJ8NVIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
AVOBENZONEG63QQF2NOXACTIB
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE75D21FL1PIIACT

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
2c494b27-5187-c3a8-e063-6394a90acd91fe95fdbf-73df-a587-e053-6394a90a53a02025-01-22Warnings, Adverse reactionsExact identifier
spl id: 2c494b27-5187-c3a8-e063-6394a90acd91
spl set id: fe95fdbf-73df-a587-e053-6394a90a53a0

Reported adverse events (FAERS/openFDA)#

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