FDA.reportPublic FDA data

Neora

Product NDC
72935-003
11-digit product format
729350003
Labeler code
72935
Product ID
72935-003_08698eda-076f-5919-e063-6294a90a1fa2
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
GEL
Route
TOPICAL
Labeler
Neora, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-01
Substance
OCTISALATE; AVOBENZONE; HOMOSALATE
Active strength
5; 3; 9.5 g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Neora
Brand name suffix
Age IQ Invisi-Bloc Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE5 g/100mL
AVOBENZONE3 g/100mL
HOMOSALATE9.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f2f3601f-081a-4bae-e053-2a95a90a4facAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72935-003-302023-10-23C16284748780-10191ceaa-6461-198a-e063-dbdaa90aec3eNeora Age IQ INVISI-BLOC Sunscreen Gel
72935-003-302023-07-28C16284748780-10191ceaa-6461-198a-e063-dbdaa90aec3eNeora Age IQ INVISI-BLOC Sunscreen Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72935-003-30NeoraAge IQ Invisi-Bloc Sunscreen30 mL in 1 TUBEGEL302
72935-003-30NeoraAge IQ Invisi-Bloc Sunscreen1 in 1 CARTONGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72935-003NEORA AGE IQ INVISI-BLOC SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [NEORA, LLC]2Current NDC, 2 package rows20231024_f2f3601f-081a-4bae-e053-2a95a90a4fac.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 255 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Softlips PearlOCTINOXATE, OCTISALATEThe Mentholatum Company43e175b4-7a48-431e-bf27-9ce7dee53f5e2024-12-17WarningsExact identifier
application number: M020
Softlips Oasis Watermelon BlackberryDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Companye1213808-4dad-4fd0-871a-04bba094a3cc2024-12-17WarningsExact identifier
application number: M020
Softlips PeppermintDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company1a0062f1-fcfc-4d6a-8274-2ebbc5fbdb272024-12-17WarningsExact identifier
application number: M020
Softlips Oasis Pineapple Coconut, Peach Mango, Strawberry KiwiDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Company7c8a4921-ae45-47fb-a64e-c72b1a386d0d2024-12-17WarningsExact identifier
application number: M020
Mentholatum Medicated Lip Balm CherryDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company6edb132d-bb67-4e6c-8e18-db0305073a712024-12-17WarningsExact identifier
application number: M020
Mentholatum Medicated Lip Balm OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Companyf84cc3a4-cc9f-4a38-8b7d-cf8d6cd39df12024-12-17WarningsExact identifier
application number: M020
Mentholatum Natural Ice Sport SPF 30AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company57c35631-42d3-4c6c-bcbb-e2de92b45b132024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMary Kay Inc.5f09503e-c455-4ac2-8d07-e8e66c2daa322024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Light to MediumHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.b5ca4bed-4f89-4020-a055-9d11f4cd50582024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.e5fffd20-1d22-485a-9311-4cb4f9264f6f2024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.404990e4-9499-4186-b39d-afc31834d3342024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.6028e210-a8a3-4d84-a462-16a414c310522024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very LightHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.af22b3a5-ac72-4c2a-aa7e-6b5ca07d89e82024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Daytime Defender Sunscreen Broad Spectrum SPF 30AVOBENZONE/OCTISALATE/OCTOCRYLENEMary Kay Inc.00f0f30d-236a-fd45-e063-6294a90a747d2024-12-17WarningsExact identifier
application number: M020
Softlips Cherry Cordial, Maple Butter, Frosted BerryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companybab8447b-58b8-4160-a91e-05f9fd09ed1d2024-12-17WarningsExact identifier
application number: M020
STUDIO FIX FLUID BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDEMAKEUP ART COSMETICSfb59afc1-1dc9-f783-e053-6394a90a196b2024-12-17WarningsExact identifier
application number: M020
Mary Kay Mineral Facial Sunscreen Broad Spectrum SPF30ZINC OXIDEMary Kay Inc.0e9b15e4-e59c-f266-e063-6394a90ab81c2024-12-17WarningsExact identifier
application number: M020
MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION SUNSCREENOCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEMAKEUP ART COSMETICSe5fd3e40-de1d-4cdd-b725-4a517514ca352024-12-17WarningsExact identifier
application number: M020
STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35OCTINOXATE AND TITANIUM DIOXIDEMAKEUP ART COSMETICS2d034810-7210-4ad4-be23-ec2100f8c2f12024-12-17WarningsExact identifier
application number: M020
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEAruba Aloe Balm NVacda1640-0d35-43dc-8734-d47b00cc85ed2024-12-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72935-003-30729350003301 TUBE in 1 CARTON (72935-003-30) / 30 mL in 1 TUBE1 tube2023-07-01NoNoCurrent