FDA.reportPublic FDA data

Intelligent Elixirs Tinted Broad Spectrum SPF 30 - Tan

Product NDC
84977-0033
11-digit product format
849770033
Labeler code
84977
Product ID
84977-0033_46b89221-798f-b226-e063-6394a90ab4be
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octisalate, Octinoxate
Dosage form
LOTION
Route
TOPICAL
Labeler
Intelligent Elixirs, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-04
Substance
OCTISALATE; OCTINOXATE; AVOBENZONE
Active strength
5; 7.5; 3 g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Intelligent Elixirs Tinted Broad Spectrum SPF 30 - Tan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE5 g/100mL
OCTINOXATE7.5 g/100mL
AVOBENZONE3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
287a61d8-0056-6211-e063-6394a90aa3daAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84977-0033-1Intelligent Elixirs Tinted Broad Spectrum SPF 30 - Tan51 mL in 1 TUBELOTION512
84977-0033-1Intelligent Elixirs Tinted Broad Spectrum SPF 30 - Tan1 in 1 CARTONLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84977-0033INTELLIGENT ELIXIRS TINTED BROAD SPECTRUM SPF 30 - NATURAL (AVOBENZONE, OCTISALATE, OCTINOXATE) LOTION INTELLIGENT ELIXIRS TINTED BROAD SPECTRUM SPF 30 - GOLDEN (AVOBENZONE, OCTISALATE, OCTINOXATE) LOTION INTELLIGENT ELIXIRS TINTED BROAD SPECTRUM SPF 30 - TAN (AVOBENZONE, OCTISALATE, OCTINOXATE) LOTION [INTELLIGENT ELIXIRS, LLC]1Current NDC, 2 package rows20241207_287a61d8-0056-6211-e063-6394a90aa3da.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 98 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eucerin Face immersive HydrationAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Incfe0b3717-f472-3a61-e053-6394a90a44fb2025-12-31WarningsExact identifier
application number: M020
NIVEA MEN Age Defense Face MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inc27cbec3e-e811-6498-e063-6394a90ada492025-12-31WarningsExact identifier
application number: M020
Nivea Men Maximum Hydration FaceAVOBENZONE, OCTISALATE, OCTOCRYLENEBeiersdorf Incf1276b11-6683-e982-e053-2a95a90a78032025-12-31WarningsExact identifier
application number: M020
Nivea Men Sensitive ProtectiveAVOBENZONE, OCTISALATE, OCTOCRYLENEBeiersdorf Incf6cff3d1-cca5-4b3e-a481-0c4def90684c2025-12-31WarningsExact identifier
application number: M020
Nivea Smoothness Lip CareAVOBENZONE,OCTOCRYLENEBeiersdorf Incc28e327d-ad39-9bd6-e053-2a95a90a04eb2025-12-31WarningsExact identifier
application number: M020
BOTANICAL SOOTHING SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INC00a923fe-e6da-420e-a705-4773ecc2176b2025-12-31WarningsExact identifier
application number: M020
AROMA MATTE DAY SUNSCREEN SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INCf822f3ec-3c57-100a-e053-6294a90ab0ec2025-12-31WarningsExact identifier
application number: M020
CONTROL CORRECTIVE TINTED MOISTURIZER SPF-30 SUNSCREENTITANIUM DIOXIDE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INC8ac09149-f7e7-40a8-b306-98964d0cd6e32025-12-31WarningsExact identifier
application number: M020
CONTROL CORRECTIVE SUNSCREEN SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INCe389b2bc-bb1c-443a-9bf6-c6d96380f3782025-12-31WarningsExact identifier
application number: M020
CONTROL CORRECTIVE INTENSIVE SKIN BRIGHTENING SPF-30 SUNSCREENOCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INC61b6dab9-3378-4206-bf1f-6f385a9c882c2025-12-31WarningsExact identifier
application number: M020
Blue Lizard Sensitive SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories32d78048-d281-1d80-e063-6394a90aec192025-12-31WarningsExact identifier
application number: M020
DAYWEAR ANTI OXIDANT 72H-HYDRATION SORBET CREME BROAD SPECTRUM SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEESTEE LAUDER INCdf535004-c94c-4a28-ad20-78bd1741e39f2025-12-31WarningsExact identifier
application number: M020
FUTURIST SKIN TINT SERUMOCTINOXATE,OCTISALATE,ZINC OXIDEESTEE LAUDER INCea21e5a5-69d6-2de4-e053-2995a90a93b42025-12-31WarningsExact identifier
application number: M020
Dr.Jart Cicapair Tiger Grass Color Correcting TreatmentZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.40f96baf-0359-4d68-801f-68562c9094462025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Fair-LightZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.b38b1b64-b433-4e11-9cf6-2108a552d1392025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Light Medium-MediumZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.45b1c2c6-a45b-4a45-bec9-e5341079c0a12025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Medium-TanZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.28a2ba45-1eff-488c-aae4-362b9f78b8df2025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Deep Tan-DeepZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.3c346960-b76b-4241-a188-8ee6948530782025-12-31WarningsExact identifier
application number: M020
DR.JART CICAPAIR TIGER GRASS CAMO DROPSZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.f06348f5-4ebc-325b-e053-2a95a90ada522025-12-31WarningsExact identifier
application number: M020
DR.JART EVERY SUN DAY MINERAL SUN SCREENTITANIUM DIOXIDE, ZINC OXIDEHave & Be Co., Ltd.f06c31b4-da5f-6495-e053-2995a90ae67c2025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84977-0033-1849770033011 TUBE in 1 CARTON (84977-0033-1) / 51 mL in 1 TUBE1 tube2024-12-04NoNoCurrent