FDA.reportPublic FDA data

EB-5 Super Hydrating Anti-Aging SPF-50

Product NDC
84060-439
11-digit product format
840600439
Labeler code
84060
Product ID
84060-439_1b1351b4-4425-3bb5-e063-6394a90a683f
Type
HUMAN OTC DRUG
Nonproprietary name
OCTOCRYLENE, ZINC OXIDE, OCTISALATE
Dosage form
CREAM
Route
TOPICAL
Labeler
LIFE O, INC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-26
Substance
OCTOCRYLENE; ZINC OXIDE; OCTISALATE
Active strength
100; 80; 50 mg/mL; mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
EB-5 Super Hydrating Anti-Aging SPF-50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE100 mg/mL
ZINC OXIDE80 mg/mL
OCTISALATE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
SOI2LOH54ZInternal 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
b9521112-d119-4d48-8504-4e46b434f76fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84060-439-00EB-5 Super Hydrating Anti-Aging SPF-5050 mL in 1 TUBECREAM503
84060-439-00EB-5 Super Hydrating Anti-Aging SPF-501 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84060-439EB-5 SUPER HYDRATING ANTI-AGING SPF-50 (OCTOCRYLENE, ZINC OXIDE, OCTISALATE) CREAM [LIFE O, INC.]3Current NDC, 2 package rows20240618_b9521112-d119-4d48-8504-4e46b434f76f.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 118 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eclipse Body Non TintedZINC OXIDEDENISE BELL SKIN CARE396f56df-d0de-1344-e063-6294a90a46ea2025-12-15Exact identifier
application number: M020
Solar Shield TintedTITANIUM DIOXIDE, ZINC OXIDEDENISE BELL SKIN CARE396eb781-5947-3665-e063-6294a90a38dd2025-12-15Exact identifier
application number: M020
Sun Veil Illuminating Sunscreen SPF30ZINC OXIDEKoco Life LLC46001097-540e-65da-e063-6294a90af2992025-12-15WarningsExact identifier
application number: M020
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC3542d8d3-35a3-7d63-e063-6394a90a6fd12025-12-15Exact identifier
application number: M020
Mineral Primer non-tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC354357de-1a85-3bdb-e063-6294a90aa9a22025-12-15Exact identifier
application number: M020
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC35433254-1dc8-a8f3-e063-6394a90a29f02025-12-15Exact identifier
application number: M020
Sun Therapy SunscreenZINC OXIDESkin Therapy Studio LLC3544916b-3f63-3a7a-e063-6394a90ae5072025-12-15Exact identifier
application number: M020
Ultra Zinc Mineral Non TintedZINC OXIDESkin Therapy Studio LLC3545d603-3d01-c51d-e063-6394a90a15992025-12-15Exact identifier
application number: M020
Sun Therapy SunscreenZINC OXIDESkin Therapy Studio LLC357efafb-aa1c-0d69-e063-6394a90a51352025-12-15Exact identifier
application number: M020
Ultra Zinc Mineral Non TintedZINC OXIDESkin Therapy Studio LLC35806102-6919-116f-e063-6294a90ad9222025-12-15Exact identifier
application number: M020
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357eee3c-1c21-5efb-e063-6294a90a4bb72025-12-15Exact identifier
application number: M020
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357e75ec-473e-df76-e063-6294a90a70c72025-12-15Exact identifier
application number: M020
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357f2f62-904a-2234-e063-6394a90aee722025-12-15Exact identifier
application number: M020
Superscreen Daytime Mineral SunscreenZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357f915a-bd77-350b-e063-6294a90ad27f2025-12-15Exact identifier
application number: M020
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357ff025-84ad-6d77-e063-6394a90aad952025-12-15Exact identifier
application number: M020
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY358021a2-235b-825b-e063-6394a90a76f52025-12-15Exact identifier
application number: M020
Superscreen Daytime Mineral SunscreenZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY35805e66-18e6-0e45-e063-6294a90afe582025-12-15Exact identifier
application number: M020
Ultra Zinc Physical DefenseZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER35474ac4-8a9d-6a84-e063-6394a90a9bad2025-12-15Exact identifier
application number: M020
Ultra Zinc Physical DefenseZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER357e315e-8802-ad73-e063-6394a90a24952025-12-15Exact identifier
application number: M020
Tinted Physical DefenseTITANIUM DIOXIDE, ZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER35477ed2-0875-58d5-e063-6294a90a3d5d2025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84060-439-00840600439001 TUBE in 1 BOX (84060-439-00) / 50 mL in 1 TUBE1 tube2023-12-26NoNoCurrent