FDA.reportPublic FDA data

NDC 69378-001 - Soothe and Hydrate Starter Set

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
69378-001
Package NDCs from labels
69378-001-16
Manufacturer
Acheson & Acheson Ltd.
Effective date
2022-12-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Soothe & Hydrate Starter SetAcheson & Acheson Ltd.2022-12-14HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69378-001-152020-02-12070687bf-9823-4f5c-ad4d-72cde86d8209
69378-001-502020-02-12070687bf-9823-4f5c-ad4d-72cde86d8209
69378-001-512020-02-12070687bf-9823-4f5c-ad4d-72cde86d8209
69378-001-152020-01-31070687bf-9823-4f5c-ad4d-72cde86d8209
69378-001-502020-01-31070687bf-9823-4f5c-ad4d-72cde86d8209
69378-001-512020-01-31070687bf-9823-4f5c-ad4d-72cde86d8209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69378-001-16Soothe and Hydrate Starter Set15 g in 1 TUBECREAM15 g5 mg in 1g3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69378-001SOOTHE AND HYDRATE STARTER SET (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) KIT [ACHESON & ACHESON LTD.]3Unmatched20221217_d78476ae-4a90-2d19-e053-2a95a90af8de.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 124 of 290 · 5,785 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Jafra Sun sunscreen broad spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b9316e16-c571-4a5c-e053-2995a90ac6a82025-10-21WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Jafra Sun tinted face protector sunscreen broad spectrum 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b8df67f8-57d9-ddc1-e053-2995a90a50c62025-10-21WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
HAWAIIAN TROPICAVOBENZONE OCTISALATE OCTOCRYLENEEdgewell Personal Care Brands LLC0b625d48-9632-0464-e063-6394a90a9adc2025-10-21WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
e l f Camo Semi Matte CC SPF 30 Deep 530 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.940e0b2d-0b10-4534-ba36-e9980cead4922025-10-21WarningsExact identifier
unii: 5A68WGF6WM
M-Natal PlusVITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, CALCIUM, IRON, ZINC, COPPERMETHOD PHARMACEUTICALS, LLC1f8785db-3e65-49d7-b017-b1a65b5ec6b12025-10-21WarningsExact identifier
unii: 9E8X80D2L0
Sodium Chloride Normal SaltSODIUM CHLORIDEMethod Pharmaceuticalsce84727a-3677-4bf0-e053-2995a90a3ec82025-10-21WarningsExact identifier
unii: 451W47IQ8X
UV SOLUTIONS MATTIFYING BROAD SPECTRUM SPF 50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENECLINIQUE LABORATORIES LLC4198cfc0-a696-e279-e063-6294a90ac2392025-10-20WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
HAWAIIAN TROPICAVOBENZONE OCTISALATE OCTOCRYLENEEdgewell Personal Care Brands LLC419b8043-7921-ca77-e063-6394a90a99ba2025-10-20WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Lip Clear Lysine Plus ColdstickOCTINOXATE AND OXYBENZONEQuantum, Inc.66f84e56-4a5d-4b71-8bd3-79961e7bf4fe2025-10-20WarningsExact identifier
unii: 4Y5P7MUD51
Super Lysine Plus Strawberry Lip TreatmentOCTINOXATE AND OXYBENZONEQuantum, Inc.2cafc97f-4cd3-4755-b394-3802c28d4ed52025-10-20WarningsExact identifier
unii: 4Y5P7MUD51
Super Lysine Plus Tangerine Lip TreatmentOCTINOXATE AND OXYBENZONEQuantum, Inc.8a00194e-9e28-4257-82e5-59bc44f7897d2025-10-20WarningsExact identifier
unii: 4Y5P7MUD51
Super Lysine Plus ColdstickOCTINOXATE AND OXYBENZONEQuantum, Inc.c9318a8c-ba3b-4068-84df-110c9005ee1d2025-10-20WarningsExact identifier
unii: 4Y5P7MUD51
Terez Honor Hydro SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDEWYCREAM INC418d054b-436f-6aa3-e063-6294a90a0f562025-10-19WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Clinical Skin Filter Tinted SunscreenCLINICAL SKIN FILTER TINTED SUNSCREENKRX RESOURCES SDN. BHD.22b8856b-671f-def3-e063-6394a90a4ea02025-10-18WarningsExact identifier
unii: 5A68WGF6WM
Clinical Skin Filter Tinted Sunscreen Medium DarkCLINICAL SKIN FILTER TINTED SUNSCREEN MEDIUM DARKKRX RESOURCES SDN. BHD.22cead37-f862-e859-e063-6394a90a86ce2025-10-18WarningsExact identifier
unii: 5A68WGF6WM
Krx Aesthetics All Day Glow SunblockerKRX AESTHETICS ALL DAY GLOW SUNBLOCKERKRX RESOURCES SDN. BHD.22a60fb9-0fea-92c0-e063-6394a90a088c2025-10-18WarningsExact identifier
unii: 5A68WGF6WM
Danahan Moisture Daily Sunscreen Broad Spectrum SPF 50ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDECosmocos Co., Ltd41129799-85ed-2de2-e063-6394a90ab40c2025-10-17WarningsExact identifier
unii: 5A68WGF6WM
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCc5a67314-e5b2-4dd6-94e9-39c2f286c3462025-10-17WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Walgreens Ultra LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4533-2061-e063-6394a90a6e732025-10-17WarningsExact identifier
unii: 6DC9Q167V3
WalgreensSODIUM CHLORIDEWalgreen Company21dfc2cf-65ae-c3fb-e063-6294a90a0a942025-10-17Exact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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