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 62 of 218 · 4,358 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands, LLC56ab90db-51bd-ffb3-e063-6294a90a852b2026-01-06WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands, LLC56ac28e7-41f1-bd4e-e063-6294a90a0e7b2026-01-06WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Moisturizing Antioxidant SPF 50OCTINOXATE, OCTISALATE, HOMOSALATE, OXYBENZONE, ZINC OXIDETopiderm, Inc.727c14d3-ad26-4e8b-91f6-b7a5f07e4e2f2026-01-05WarningsExact identifier
unii: V06SV4M95S
unii: 4X49Y0596W
ANTISEPTIC CLEANSING WIPE(0.9% NACL)ANTISEPTIC CLEANSING WIPE(0.9% NACL)SHENZHEN BENLIJU BIO-TECH CO.,LTD33e1c026-8a35-a47a-e063-6294a90a24062026-01-05WarningsExact identifier
unii: HIE492ZZ3T
ORLASKIN HYDRATING SUNSCREENORLASKIN HYDRATING SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd0808b0cd-2cfb-8554-e063-6294a90ad6c42026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC228fab45-e0d2-f219-e063-6294a90a1ef62026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC228055ec-ff59-4412-e063-6394a90abe142026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAYAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION4bd99626-690b-49e8-8c42-a2e2dbca09bf2026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
cle de peau BEAUTE LONG-LASTING HYDRATING VEILAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf04ece6c-66b6-48e9-8f6b-e898a538ba002026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
cle de peau BEAUTE BRIGHTENING ENHANCER VEILOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbb00d6d7-cc51-4fee-a0df-68bbd5bc50d62026-01-05WarningsExact identifier
unii: 5A68WGF6WM
cle de peau BEAUTE PROTECTIVE LIP TREATMENT SPF 25AVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONaddd9885-362c-4ce0-9a6e-759e71d8756c2026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
cle de peau BEAUTE PROTECTIVE FORTIFYING nAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION65ca1240-6ee8-40c0-b62f-3597e0872c6e2026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Dominas Dark Spot UV Defense Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co.,Ltd.098c0a9b-2b96-6be3-e063-6294a90a959a2026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Poolside Butter Screen SPF 30 Sunscreen ButterHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCae838725-79ab-4c17-905b-d4138ad6af1f2026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Poolside Bronze Service Instant Bronzing Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONEI World LLCb98a9cec-3c48-4614-b091-4e59fa7d196e2026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Poolside Orange Creme SPF 30 Sunscreen Oil MistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC5a9f8888-529d-40d7-9489-baa5ff657cb42026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
SHISEIDO FUTURE solution LX UNIVERSAL DEFENSE EOCTISALATE, OCTOCRYLENE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATION6d2f82d5-b3af-44af-b6b0-de96a4cd95fc2026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: 4X49Y0596W
SHISEIDO VITAL PERFECTION UPLIFTING AND FIRMING DAYAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND HOMOSALATESHISEIDO AMERICAS CORPORATION4a16dbb7-e860-4aae-8e8b-67abbe8295bd2026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
SHISEIDO ULTIMATE SUN PROTECTOROCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATIONc656792a-e1ed-478d-b501-9bdc92d16eca2026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: 4X49Y0596W
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING nAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION207e2035-5f31-4745-a801-b386b040b7382026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX

Reported adverse events (FAERS/openFDA)#

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