FDA.reportPublic FDA data

NewGel Plus SPF

Manufacturer
Newmedical Technology, Inc.
Effective date
2017-11-07
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 22:52:53

Label at a glance#

ProductNewGel Plus SPF
Active ingredientZINC OXIDE
Label structure6 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Purpose Zinc Oxide 20% SunscreenPurpose Zinc Oxide 20% Sunscreen

INACTIVE INGREDIENT SECTION

Inactive IngredientsInactive Ingredients

WARNINGS SECTION

WarningsWarnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC-Keep out of Reach of ChildrenOTC-Keep out of Reach of Children

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20% SunscreenZinc Oxide 20% Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Silagen Bottle Pump 69291-6215-2Silagen Bottle Pump 69291-6215-2Silagen CartonSilagen CartonSilagen BottleSilagen BottleSilagen CartonSilagen CartonPackage LabelPackage Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69291-0850-12020-01-31C16284748780-19d75b9d0-4279-f424-e053-dadaa90a57ce051735b9-d24c-595d-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69291-0850-1NewGel Plus SPF1 in 1 CARTONGEL15
69291-0850-2NewGel Plus SPF15 g in 1 BOTTLE, PUMPGEL155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69291-0850NEWGEL PLUS SPF (ZINC OXIDE, SUNSCREEN) GEL [NEWMEDICAL TECHNOLOGY, INC.]5Legacy NDC, 2 package rows20171107_051735b9-d24c-595d-e054-00144ff88e88.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)INACTIVE INGREDIENTUF7620L1W61
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0F1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69291-085069291-0850-2, 69291-0850-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ZINC OXIDESOI2LOH54ZACTIB

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
5d67ccc0-6b15-f8f8-e053-2a91aa0a5630051735b9-d24c-595d-e054-00144ff88e882017-11-07WarningsExact identifier
spl id: 5d67ccc0-6b15-f8f8-e053-2a91aa0a5630
spl set id: 051735b9-d24c-595d-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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