FDA.reportPublic FDA data

XXL Sun Block SPF 50

Manufacturer
Peer Pharma Ltd.
Effective date
2019-09-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:13

Label at a glance#

ProductXXL Sun Block SPF 50
Active ingredientOCTOCRYLENE, OCTISALATE, AVOBENZONE, HOMOSALATE, OXYBENZONE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

XXL Sun BlockXXL Sun Block

OTC - ACTIVE INGREDIENT SECTION

Oxybenzone​ 7%

Octocrylene 4%

Octisalate 5%

Avobenzone 3%

Homosalate 13%

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PURPOSE SECTION

Provides SPF 50 protection

INDICATIONS & USAGE SECTION

Directions for Use: Apply generously to face and body regularly before sun exposure and as needed.

Reapply: after 40 minutes before of or 80 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours.

WARNINGS SECTION

DOSAGE & ADMINISTRATION SECTION

Directions for Use: Apply generously to face and body regularly before sun exposure and as needed.

Reapply: after 40 minutes before of or 80 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours.

INACTIVE INGREDIENT SECTION

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69435-1905-12021-01-29C16284748780-1ba0f9c33-3225-a910-e053-dadaa90a0b85Gold Cosmetics XXL Sun Block SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69435-1905-1XXL Sun Block SPF 50100 mL in 1 CONTAINERCREAM1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69435-1905XXL SUN BLOCK SPF 50 (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, HOMOSALATE CREAM) CREAM [PEER PHARMA LTD.]1Legacy NDC, 1 package rows20190907_91e7d23d-2bea-545b-e053-2995a90a75e4.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69435-190569435-1905-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
JOJOBA OIL724GKU717MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALMOND OIL66YXD4DKO9IACT
DMDM HYDANTOINBYR0546TOWIACT
ALLANTOIN344S277G0ZIACT
CHLORPHENESINI670DAL4SZIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ASCORBYL TETRAISOPALMITATE47143LT58AIACT
ISOHEXADECANE918X1OUF1EIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERINPDC6A3C0OXIACT
PUNICA GRANATUM ROOT BARKCLV24I3T1DIACT
SHEA BUTTERK49155WL9YIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
NIACINAMIDE25X51I8RD4IACT
DIMETHICONE92RU3N3Y1OIACT
SEA SALT87GE52P74GIACT
ALOE VERA LEAFZY81Z83H0XIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PANTHENOLWV9CM0O67ZIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CHAMAEMELUM NOBILE FLOWERO2T154T6OGIACT
AVOCADO OIL6VNO72PFC1IACT
WATER059QF0KO0RIACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OXYBENZONE95OOS7VE0YACTIB
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEANQ870JD20IACT

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
91e7bee2-7de8-542f-e053-2995a90aec4f91e7d23d-2bea-545b-e053-2995a90a75e42019-09-06Exact identifier
spl id: 91e7bee2-7de8-542f-e053-2995a90aec4f
spl set id: 91e7d23d-2bea-545b-e053-2995a90a75e4

Reported adverse events (FAERS/openFDA)#

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