FDA.reportPublic FDA data

Anti Aging Lip Balm Pot SPF 15

Product NDC
84378-103
11-digit product format
843780103
Labeler code
84378
Product ID
84378-103_56331742-cd4b-67d5-e063-6294a90aa19d
Type
HUMAN OTC DRUG
Nonproprietary name
Lip Balm
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Epicuren Disocovery
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-07
Substance
AVOBENZONE; OCTISALATE; OCTINOXATE
Active strength
3; 4.5; 7.5 g/100g; g/100g; g/100g
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
Anti Aging Lip Balm Pot SPF 15
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100g
OCTISALATE4.5 g/100g
OCTINOXATE7.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4097e28a-ed11-e16a-e063-6294a90a5e9bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84378-103-07Anti Aging Lip Balm Pot SPF 157 g in 1 JAROINTMENT71

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 27 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUNFORGETTABLE TOTAL FACE PROTECTION FACE SHIELD CLASSICZINC OXIDEColorescienced46533c7-c92d-d161-e053-2995a90a8e4b2026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Face Shield GlowZINC OXIDEColoresciencecdb5397a-c463-4b41-e053-2a95a90a9e032026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Face Shield MatteZINC OXIDEColoresciencecd879b3e-16a2-2cca-e053-2a95a90a14f82026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Body ShieldZINC OXIDEColoresciencecdb413bb-58ab-1e0f-e053-2995a90aab0f2026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Face Shield FlexZINC OXIDEColoresciencecdb55347-aedd-4de6-e053-2a95a90afec72026-05-21WarningsExact identifier
application number: M020
Odacite Flex Perfecting Mineral Drops Tinted SunscreenZINC OXIDEOdacite52560b2d-ebb5-5d96-e063-6294a90a15ee2026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Face Shield BronzeZINC OXIDEColoresciencecdb577e4-5c80-7eac-e053-2a95a90a105b2026-05-21WarningsExact identifier
application number: M020
Mineral SPF 30 MoisturizerMINERAL SPF 30 MOISTURIZERDont Run Out Inc (DBA: Public Goods)52462e7e-0c2c-6b64-e063-6394a90a42302026-05-21WarningsExact identifier
application number: M020
Tinted Mineral Sunscreen 20% Zinc OxideZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC52564e2f-983d-89ba-e063-6394a90ab4242026-05-21WarningsExact identifier
application number: M020
DRMTLGY Radiance PowderTITANIUM DIOXIDE, ZINC OXIDEDRMTLGY15bda8d5-8c3c-6ba5-e063-6394a90a82d92026-05-21WarningsExact identifier
application number: M020
Agent Natuer holi (sun) dewy tinted skin dropsZINC OXIDEAgent Natuer043734b8-9aee-cdf1-e063-6294a90aec602026-05-21WarningsExact identifier
application number: M020
Organys Derma MadeZINC OXIDEOrganys Beauty09bb5f97-f4db-a2d4-e063-6394a90a84fd2026-05-21WarningsExact identifier
application number: M020
Skin Metal Green StealthZINC OXIDESkin Metal47f562cc-48cc-97f9-e063-6294a90a72162026-05-21WarningsExact identifier
application number: M020
Blume Sunburst SunscreenZINC OXIDEBlume21ef2c6b-8ae7-8bcf-e063-6294a90ae9e12026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST13 KAMARI)ZINC OXIDEIlia, Inc.b595ca2c-177e-b357-e053-2995a90a54f62026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST6 ORA)ZINC OXIDEIlia, Inc.b59537d4-e1d8-53e4-e053-2995a90a2ce32026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST16 PAVONES)ZINC OXIDEIlia, Inc.b595f1e9-36f7-615d-e053-2a95a90abb1c2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST2.5 SOMBRIO)ZINC OXIDEIlia, Inc.b97dc2ac-dd6d-403d-e053-2995a90a0d9c2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST14 DOMINICA)ZINC OXIDEIlia, Inc.b595db16-7969-726f-e053-2995a90ab7832026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST11 MATIRA)ZINC OXIDEIlia, Inc.b595b5f0-dd3d-79ef-e053-2a95a90ad9fb2026-05-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84378-103-07843780103077 g in 1 JAR (84378-103-07) 7 g2025-10-07NoNoCurrent