FDA.reportPublic FDA data

NDC 69291-0850-2 - NewGel Plus SPF

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
69291-0850
Requested NDC
69291-0850-2
Package NDCs from labels
69291-0850-2, 69291-0850-1
Manufacturer
Newmedical Technology, Inc.
Effective date
2017-11-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NewGel Plus SPF - Newmedical Technology, Inc.Newmedical Technology, Inc.2017-11-07HUMAN OTC DRUG 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
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZSILAGEN (ZINC OXIDE, SUNSCREEN) GEL [NEWMEDICAL TECHNOLOGY INC.]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZSILAGEN (ZINC OXIDE, SUNSCREEN) GEL [NEWMEDICAL TECHNOLOGY INC.]1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQSILAGEN (ZINC OXIDE, SUNSCREEN) GEL [NEWMEDICAL TECHNOLOGY INC.]1
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQSILAGEN (ZINC OXIDE, SUNSCREEN) GEL [NEWMEDICAL TECHNOLOGY INC.]1
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)INACTIVE INGREDIENTUF7620L1W6SILAGEN (ZINC OXIDE, SUNSCREEN) GEL [NEWMEDICAL TECHNOLOGY INC.]1
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0FSILAGEN (ZINC OXIDE, SUNSCREEN) GEL [NEWMEDICAL TECHNOLOGY INC.]1

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 49 of 203 · 4,043 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coppertone Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Incd8d80a15-8282-a18e-e053-2a95a90a2c6c2025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Coppertone Sunscreen SPF 50ZINC OXIDE 20%Beiersdorf Incd46359e7-b585-c43a-e053-2995a90a08632025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Sei Bella CC Brightening Creme LightOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.6894b9d9-a5b5-4c98-e053-2991aa0a9ca22025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Sei Bella CC Brightening Creme FairOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.6892952a-d032-30bf-e053-2a91aa0a3bba2025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Sei Bella CC Brightening Creme Medium TanOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.68a4e8b4-36cb-6306-e053-2a91aa0a6d252025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Sei Bella CC Brightening Creme MediumOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.68a4ed34-f492-67a6-e053-2a91aa0a04282025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Sei Bella Daily UV Defense Broad-Spectrum SPF 25 SunscreenSUNSCREENMelaleuca Inc.1f1d1575-cf37-5d66-e063-6394a90ab2a32025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Sei Bella Tinted BB Moisturizing Creme Sheer to Light 140 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.a13e5326-73c3-9fa8-e053-2a95a90aae9d2025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Sei Bella Tinted BB Moisturizing Creme Sheer to Light 20 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.a13e3f45-8e6f-6a3f-e053-2995a90a17d22025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Sei Bella Tinted BB Moisturizing Creme Deep 550 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e31a82-0cd0-5a1a-e053-2991aa0a33f82025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Sei Bella Tinted BB Moisturizing Creme Light to Medium 200 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e2dfaa-d173-e6a9-e053-2a91aa0a46632025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Sei Bella Tinted BB Moisturizing Creme Medium 300 WTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e2e541-c583-0f12-e053-2991aa0a4ab22025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Sei Bella Tinted BB Moisturizing Creme Medium to Deep 500 WTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e30231-4fba-35d4-e053-2991aa0a33cb2025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Sei Bella Tinted BB Moisturizing Creme Medium 440 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e30255-5640-3b4a-e053-2991aa0ab3f72025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Sei Bella Tinted BB Moisturizing Creme Medium to Deep 450 WTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e30255-564f-3b4a-e053-2991aa0ab3f72025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Sei Bella Tinted BB Moisturizing Creme Medium 320 CTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e2e541-c596-0f12-e053-2991aa0a4ab22025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Sei Bella Tinted BB Moisturizing Creme Light to Medium 160 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e20c57-7b30-4e96-e053-2991aa0aab3e2025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Sun Shades Mineral Plus Sunscreen with Zinc OxideOCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%Melaleuca Inc.8886cbd0-ed2b-4a2b-a724-a0d4f12296c92025-12-31WarningsExact identifier
unii: SOI2LOH54Z
BOTANICAL SOOTHING SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INC00a923fe-e6da-420e-a705-4773ecc2176b2025-12-31WarningsExact identifier
unii: SOI2LOH54Z
AROMA MATTE DAY SUNSCREEN SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INCf822f3ec-3c57-100a-e053-6294a90ab0ec2025-12-31WarningsExact identifier
unii: SOI2LOH54Z

Reported adverse events (FAERS/openFDA)#

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