FDA.reportPublic FDA data

NDC 61354-047-01 - Sunscreen

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
61354-047
Requested NDC
61354-047-01
Package NDCs from labels
61354-047-01, 61354-047-02, 61354-047-03, 61354-047-04
Manufacturer
Oxygen Development, LLC
Effective date
2023-02-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sunscreen - Oxygen Development, LLCOxygen Development, LLC2023-02-03HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61354-047-042025-01-30C16284748780-12cef2736-8b50-d83d-e063-dadaa90ab31fBroad Spectrum Sunscreen Clear as Day SPF 46 Starface

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-047-01Sunscreen100 mg in 1 TUBEGEL1002
61354-047-02Sunscreen1 in 1 PACKAGEGEL12
61354-047-03Sunscreen1 in 1 CARTONGEL12
61354-047-04Sunscreen1 in 1 PACKAGEGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-047SUNSCREEN (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) GEL [OXYGEN DEVELOPMENT, LLC]2Legacy NDC, 4 package rows20230204_d7fe4990-507e-4062-e053-2a95a90ae6d9.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 171 of 175 · 3,495 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLARINS UV PLUS ANTI-POLLUTION BROAD SPECTRUM SPF 50 NON-TINTED Sunscreen Multi-ProtectionHOMOSALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDELaboratoires Clarins0695e3a4-0e8f-419e-b128-9b02bdb8b02a2023-10-11WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
Orange Soda SPF 15 Broad Spectrum Lip BalmORANGE SODA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca0c362ae-b878-c630-e053-2995a90ad4c42023-10-10WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
TOM FORD SHADE AND ILLUMINATE SOFT RADIANCE FOUNDATION BROAD SPECTRUM SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDETOM FORD BEAUTY DIST4bae83b7-2c98-4928-8e71-bb4f19cc48f02023-10-05WarningsExact identifier
unii: 4X49Y0596W
CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - VERY DRY/DRYAVOBENZONE AND OCTISALATECLINIQUE LABORATORIES LLC59eeb180-1ac6-44b3-9742-dc65287896bf2023-10-05WarningsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
REPAIRWEAR LASER FOCUS LINE SMOOTHING BROAD SPECTRUM SPF 15 -VERY DRY TO DRY COMBINATIONOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC4c40047b-01d6-4221-a044-9f884519bdd52023-10-05WarningsExact identifier
unii: 4X49Y0596W
CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - COMBINATION/OILY TO OILYAVOBENZONE AND OCTISALATECLINIQUE LABORATORIES LLC9c9a0fa4-b440-4d7f-805e-d997e120024d2023-10-05WarningsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
Laura Mercier Pure Canvas Primer Protecting Broad Spectrum SPF 30 SunscreenOCTINOXATE, OCTOCRYLENE, AVOBENZONE, AND OXYBENZONELaura Mercier US Buyer LLCe7903f3d-9c59-f397-e053-2995a90a78952023-10-04WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Laura Mercier Tinted Moisturizer Light Revealer Natural Skin Illuminator Broad Spectrum SPF 25 Sunscreen 0N1 PetalAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENELaura Mercier US Buyer LLCe78e17bf-5606-1031-e053-2a95a90adb352023-10-04WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Laura Mercier Tinted Moisturizer Natural Skin Perfector Broad Spectrum SPF 30 Sunscreen 0N1 PetalAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONELaura Mercier US Buyer LLCe78f9689-2f8b-1524-e053-2995a90adc792023-10-04WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Laura Mercier Flawless Skin Repair Day Creme Broad Spectrum SPF 15 SunscreenAVOBENZONE, OCTINOXATE, AND OXYBENZONELaura Mercier US Buyer LLCe931d389-6b3d-5a7d-e053-2a95a90a7aa32023-10-04WarningsExact identifier
unii: G63QQF2NOX
PLANTSCRIPTION SPF 25 POWER ANTI AGING BROAD SPECTRUM 25AVOBENZONE, HOMOSALATE, OCTISLATE, AND OCTOCRYLENEORIGINS NATURAL RESOURCES INC.c706fed8-f215-4c53-bfc5-2bd87b8f884e2023-09-11WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Anubis Barcelona Vital LineHYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDESANUBIS COSMETICS SLebe024f7-7c45-ad60-e053-2995a90a45d62023-09-01WarningsExact identifier
unii: G63QQF2NOX
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: G63QQF2NOX
Bath and Body Works SPF20 Coconut Lip BalmSPF20 LIP BALMAutumn Harpf5744a48-2b39-4949-e053-2a95a90ab15d2023-02-24WarningsExact identifier
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
f3cf2641-92cd-67b2-e053-2a95a90ab73bd7fe4990-507e-4062-e053-2a95a90ae6d92023-02-03WarningsExact identifier
spl id: f3cf2641-92cd-67b2-e053-2a95a90ab73b
spl set id: d7fe4990-507e-4062-e053-2a95a90ae6d9
Replenix Lip Therapy homosalateHOMOSALATETopiderm, Inc.b60dc004-d713-47bc-a6e9-ea4783aa70192023-02-02WarningsExact identifier
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless PrimerAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENECharlotte Tilbury Beauty Ltd.d34669b8-acbc-7c93-e053-2a95a90adbe42022-07-15WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Basin French Pear SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a39d91c-2dcf-71d6-e063-6394a90a54742022-02-10WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W

Reported adverse events (FAERS/openFDA)#

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