FDA.reportPublic FDA data

Essential Sunscreen SPF50

Manufacturer
Milbar Laboratories | Milbar Labs, Inc.
Effective date
2024-07-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:16:21

Label at a glance#

ProductEssential Sunscreen SPF50
Active ingredientZINC OXIDE, OCTINOXATE
Label structure6 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Dosage and administrationDosage and administration

WARNINGS SECTION

WarningsWarnings

INACTIVE INGREDIENT SECTION

Inactive ingredientsInactive ingredients

INDICATIONS & USAGE SECTION

indications and usageindications and usage

OTC - PURPOSE SECTION

PurposePurpose

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal DisplayPrincipal Display

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57577-571-01Essential Sunscreen SPF50100 mL in 1 TUBELOTION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57577-571ESSENTIAL SUNSCREEN SPF50 LOTION [MILBAR LABORATORIES]11 package rows20240802_1e6410d5-c522-5249-e063-6294a90ac503.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57577-57157577-571-01

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
CAPRYLYL GLYCOL00YIU5438UIACT
CHLORPHENESINI670DAL4SZIACT
XANTHAN GUMTTV12P4NEEIACT
SQUALANEGW89575KF9IACT
ISODODECANEA8289P68Y2IACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
PENTYLENE GLYCOL50C1307PZGIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PEG-40 MONOSTEARATEECU18C66Q7IACT
OCTINOXATE4Y5P7MUD51ACTIB
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
STEARYL ALCOHOL2KR89I4H1YIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PEG-10 DIMETHICONE (220 CST)287GF3Y3WCIACT

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
1e6410d5-c523-5249-e063-6294a90ac5031e6410d5-c522-5249-e063-6294a90ac5032024-07-29WarningsExact identifier
spl id: 1e6410d5-c523-5249-e063-6294a90ac503
spl set id: 1e6410d5-c522-5249-e063-6294a90ac503

Reported adverse events (FAERS/openFDA)#

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