FDA.reportPublic FDA data

NDC 49967-397 - Garnier Ombrelle Complete Sensitive Advanced Lightweight hypoallergenic SPF 45 Mexoryl Technology

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
49967-397
Package NDCs from labels
49967-397-01, 49967-397-02
Manufacturer
L'Oreal USA Products Inc | L'OREAL USA PRODUCTS, INC.
Effective date
2025-12-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Drug FactsL'Oreal USA Products Inc | L'OREAL USA PRODUCTS, INC.2025-12-09HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-397-01Garnier Ombrelle Complete Sensitive Advanced Lightweight hypoallergenic SPF 45 Mexoryl Technology1 in 1 CARTONLOTION14
49967-397-01Garnier Ombrelle Complete Sensitive Advanced Lightweight hypoallergenic SPF 45 Mexoryl Technology90 mL in 1 TUBELOTION904
49967-397-02Garnier Ombrelle Complete Sensitive Advanced Lightweight hypoallergenic SPF 45 Mexoryl Technology1 in 1 CARTONLOTION14
49967-397-02Garnier Ombrelle Complete Sensitive Advanced Lightweight hypoallergenic SPF 45 Mexoryl Technology200 mL in 1 TUBELOTION2004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-397GARNIER OMBRELLE COMPLETE SENSITIVE ADVANCED LIGHTWEIGHT HYPOALLERGENIC SPF 45 MEXORYL TECHNOLOGY (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE AND DROMETRIZOLE TRISILOXANE) LOTION [L'OREAL USA PRODUCTS INC]34 package rows20240101_f34fcf82-9b85-4ff8-8e80-fa92f9c5a606.zip

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 9 of 218 · 4,358 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RR Sun CremeHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEUndefined Incdc60b685-a7fc-47bb-ade9-44a8e3b548122026-07-17WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Cetaphil Tinted Daily Facial Moisturizer SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEGalderma Laboratories, L.P.0ef2ebae-7198-47f4-8891-d1ca3cf54d4b2026-07-16WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
Mederma Scar CreamAVOBENZONE, OCTOCRYLENE, AND OXYBENZONEPMI Branded Pharmaceuticals, Inc.f9be5adb-dce3-4b17-939f-d80d486f2cb02026-07-16WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
BaseLife Clear UV Defense SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWintech America, Inc.128db446-93ba-4347-bd39-66177572c6592026-07-15WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Biore Aqua Rich Facial Mist SPF 50OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATEKao USA Inc.56a80a0d-b0b5-1098-e063-6294a90a52702026-07-15WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Anti Aging Lip Balm Pot SPF 15LIP BALMEpicuren Disocovery4097e28a-ed11-e16a-e063-6294a90a5e9b2026-07-14WarningsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
X-Treme Cream Propolis Sunscreen SPF 45X-TREME CREAMEpicuren Discovery3b29976e-eee0-b978-e063-6294a90accd62026-07-14WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: 4X49Y0596W
Anti-Aging Lip Balm SPF 15LIP BALMEpicuren Discovery3cbd0550-b6e5-3e86-e063-6394a90ac07f2026-07-14WarningsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
FITISH SPF 50 FACEFITISH SPF 50 FACEFitish Holdings, LLC1c44a572-59e6-c3c5-e063-6394a90a0e242026-07-14WarningsExact identifier
unii: 5A68WGF6WM
unii: 4X49Y0596W
Vacation FaceAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.14b8a3cf-031c-4c52-ba81-e683e69d0f372026-07-14WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Mederma Scar CreamAVOBENZONE, OCTOCRYLENE, AND OXYBENZONEL. Perrigo Companybd5c9df7-8dfb-4d20-9966-e148c5667b222026-07-14WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Sun Juice Body Mist Sunscreen SPF30 - Watermelon Sugar PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC4081a4ad-b738-5fb6-e063-6394a90a91712026-07-13WarningsExact identifier
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Sun Juice Body Mist Sunscreen SPF30 - Coconut Cream PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC3cc5c1d8-91f8-8ad2-e063-6294a90a92292026-07-13WarningsExact identifier
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Olay Super Serum Body Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company5513c5e2-3baf-2f09-e063-6394a90a495a2026-07-13WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Sun Juice Body Mist Sunscreen SPF30 - Peach Sky PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC3cc48592-f70d-664e-e063-6294a90ac6e82026-07-13WarningsExact identifier
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Sun Juice Body Mist Sunscreen SPF30 - Cotton Candy Skies PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC568083ff-0da9-7f14-e063-6394a90a43012026-07-13WarningsExact identifier
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Sun Juice Body Mist Sunscreen SPF30 - Vanilla Breeze PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC3cc62c97-70c5-17f7-e063-6394a90abe252026-07-13WarningsExact identifier
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Cold Sore Fever Blister TreatmentDOCOSANOLSportpharm LLCe3e6c0b0-399f-41e4-9df9-109ee29179952026-07-12WarningsExact identifier
unii: 9G1OE216XY

Reported adverse events (FAERS/openFDA)#

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